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Medical advancements and improvements in how doctors treat disease are made possible by what we learn through clinical trials. Commonly done in a medical setting such as a hospital, clinical trials are research studies that evaluate the safety and effectiveness of new treatments, whether they are drugs, devices, or preventative and other therapeutic measures that can influence health. Patients who participate in clinical trials have the opportunity to access treatments before they are publically available and also help others by contributing to medical research.  

Atlantic Health System hospitals participate in numerous clinical trials in partnership with other research organizations and pharmaceutical or biotech sponsors. Please browse the listing of clinical trials below to learn more about our open and active studies. Our physicians are committed to finding the latest treatments within a variety of medical areas, with a particular focus on cancer, genetics and congenital disease, movement disorders such as Parkinson’s disease, pediatrics, valve disease, and women’s health. 

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Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
973-630-2233
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
973-630-2233
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
973-630-2233
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
973-630-2233
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Bowel Disease
Open to Enrollment

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration...

Investigator:
Razvan Arsenescu, MD

in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

CNTO1275UCO3001 | PHASE III

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening
• Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (>=) 2 as determined by a central reading of the video endoscopy
• Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
• Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks

Exclusion Criteria:
• Has severe extensive colitis and is at imminent risk of colectomy
• Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon
• Presence of a stoma or history of a fistula
• Participants with history of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity
• Participants with history of colonic mucosal dysplasia. Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia''

Contact:
973-630-2232
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Bowel Disease
Open to Enrollment

An Open-Label, Multicenter, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically

The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.

Investigator:
Razvan Arsenescu, MD
Vedolizumab-4001 | PHASE IV

Sponsor:
Takeda Development Center Americas, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Is capable of understanding and complying with protocol requirements.
2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Is female and at least 18 years of age at the time of informed consent.
4. Weighs at least 50 kilogram at Screening and Day 1.
5. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study.
6. Is on established vedolizumab maintenance therapy of (received at least two 300 mg once every 8 weeks doses prior to the delivery of infant and one 300 mg once every 8 weeks dose of vedolizumab postpartum), which has been commenced by the participant's treating physician for the treatment of active UC or CD prior to enrolling in this study.
7. Has delivered a single, normal term infant (at least 37 weeks' gestation) that is, a mother-infant pair is required.
8. Is at least 6 weeks postpartum by Day 1.
9. Lactation is well established and the mother is exclusively breast feeding their infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study.
10. Participant has independently decided to be treated with vedolizumab or to breastfeed prior to providing consent to participate in this study.
11. Plans to continue breastfeeding at least throughout the duration of this study.
12. Agrees to use only the emollient or nipple cream recommended by the investigator for use during the sampling period as described per protocol.

Exclusion Criteria:
1. Has received any investigational compound or approved biologic or biosimilar agent, except for vedolizumab within 60 days prior to enrollment in the study.
2. Within 30 days prior to enrollment, the participant has received any of the following for the treatment of underlying disease:
a. Nonbiologic therapies [example (eg), cyclosporine], other than those listed in the protocol.
b. An approved nonbiologic therapy in an investigational protocol.
3. Is expected to receive additional vedolizumab treatment between Day 2 and Study Exit/Follow-up (Day 57).
4. Has received natalizumab treatment.
5. Has received any live vaccinations within 30 days prior to study drug administration.
6. Has a positive test result for hepatitis B surface antigen, antibody to hepatitis C virus, at Screening or a known history of human immunodeficiency virus infection (eg, common variable immunodeficiency, human immunodeficiency virus infection, organ transplantation).
7. Has clinically significant infection (eg, pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.
8. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
9. Has evidence of unstable or uncontrolled, clinically significant cardiovascular, central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic or other medical disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures or allergic skin rash that, in the opinion of the investigator, would confound the study results or compromise participant safety. Additionally, if there is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking vedolizumab, or a similar drug that might interfere with the conduct of the study.
10. Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period.
11. Has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrollment. Participants with remote history of malignancy (eg, greater than (>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment.
12. Has a positive progressive multifocal leukoencephalopathy subjective symptom checklist at screening.
13. Has a current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
14. Has active psychiatric problems that, in the investigator's opinion, may interfere with compliance with the study procedures.
15. Has history of breast implants, breast augmentation, or breast reduction surgery.
16. Has a prior history of difficulty establishing lactation.
17. Has a positive urine/blood drug result for drugs of abuse (defined as any illicit drug use) at Screening.
18. Has donated or lost 450 milliliter or more of her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day 1.
19. Has active or latent tuberculosis (TB)

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Contact:
973-660-3553
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Bowel Disease
Open to Enrollment

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications

The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin [vedolizumab intravenous (IV)], a tumor necrosis factor (TNF) antagonist [adalimumab subcutaneously (SC)], and an immunomodulator (oral methotrexate) on...

Investigator:
Razvan Arsenescu, MD

endoscopic remission in participants with newly-diagnosed Crohn's disease stratified at higher risk for complications.

Vedolizumab-4006 | PHASE IV

Sponsor:
Takeda Development Center Americas, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
2. The participant or, when applicable, the participant's legally acceptable representative has signed and dated a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Is male or non-pregnant, non-breast-feeding female and aged 18 to 80 years, inclusive at time of Screening.
4. Has an initial diagnosis of Crohn's disease (CD) established within 24 months prior to enrollment with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
5. Has moderate to severely active CD during Screening defined by:
1. Crohn's disease activity index (CDAI) score ≥ 220 within 10 days prior to enrollment, AND
2. Centrally assessed simple endoscopic score for Crohn's disease (SES-CD) score ≥7 (or ≥4 if isolated ileal disease) during Screening, AND
3. Elevated biomarker of inflammation [C-reactive protein (CRP) >5 mg/L OR fecal calprotectin level >250 μg/g stool) during Screening.
6. By investigator judgement, the participant is assessed as having CD at moderate-high risk for complications. Investigator judgement may include clinical assessment, the Crohn's Disease Personalized Risk and Outcome Prediction Tool (PROSPECT), or criteria defined by the 2014 American Gastroenterology Association (AGA) CD Clinical Care Pathway.
7. May be receiving a stable therapeutic dose of conventional therapies for CD.
8. If on corticosteroids, must be on a stable dose of oral corticosteroids up to 20 mg of prednisone daily or 9 mg of budesonide daily for at least 7 days prior to enrollment.
9. If on corticosteroids, must be willing to follow a mandatory taper of prednisone or budesonide within 60 days after enrollment.
10. Must be willing to stop treatment with 5-aminosalicylate (5-ASA), antibiotics, and probiotics for luminal CD at enrollment.
11. Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
12. Female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
13. Family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance (may be performed during Screening as standard of care).

Exclusion Criteria:

Gastrointestinal (GI) Exclusion Criteria
1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.
2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal abscess.
3. Has a known perianal fistula with abscess. (The participant may have a perianal fistula without abscess.)
4. Has a known fistula (other than perianal fistula).
5. Had non-CD related abdominal surgery within 6 months prior to enrollment.
6. Has any prior CD-related surgery OR CD complication requiring surgery at any time (other than seton placement for perianal fistula without abscess).
7. Has a history of 2 or more non CD related small bowel resections or diagnosis of short bowel syndrome.
8. Has extensive non CD related colonic resection, ie, subtotal or total colectomy with <15 cm colon remaining.
9. Has an ileostomy, colostomy.
10. Has a history or evidence of adenomatous colonic polyps that have not been removed.
11. Has a history or evidence of colonic mucosal dysplasia.
12. Has intolerance or contraindication to undergo ileocolonoscopy.
13. Has known fixed stricture or stenosis of the intestine.

Infectious Disease Exclusion Criteria
14. Has any identified congenital or acquired immunodeficiency [eg, common variable immunodeficiency, human immunodeficiency virus (HIV) infection].
15. Has undergone organ transplantation.
16. Has evidence of an active infection during Screening.
17. Infections requiring treatment with oral (PO) or intravenous (IV) antibiotics, antivirals, or antifungals within 28 days of enrollment.
18. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
1. History of TB.
2 .A diagnostic TB test performed during Screening that is positive, as defined by:
• A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests OR
3. A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of >15 mg/day prednisone)
19. Has a history of listeria, histoplasmosis, coccidioidomycosis, blastomycosis, candidiasis, aspergillosis, legionella, or pneumocystosis.
20. Has a history of any bacterial, viral, and other infection due to opportunistic pathogens.
21. Has chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
22. Has evidence of active Clostridium difficile infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening.
23. Has received any live vaccinations within 28 days prior to enrollment.

General Exclusion Criteria
24. Has other inflammatory or rheumatic diseases (eg, psoriasis, rheumatoid arthritis, ankylosing spondylitis).
25. Had a surgical procedure requiring general anesthesia within 60 days prior to enrollment or is planning to undergo major surgery during the study period.
26. Is taking, has taken, or is required to take any excluded medications.
27. Has received either approved or investigational biologic or nonbiologic agents for the treatment of inflammatory bowel disease (IBD) in an investigational protocol.
28. Has had prior exposure to any tumor necrosis factor (TNF) antagonist including infliximab, certolizumab pegol, golimumab, adalimumab, or biosimilar TNF antagonist agents.
29. Has had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.
30. Has received either approved or investigational biologic agents for the treatment of non-inflammatory bowel disease (IBD) conditions, other than localized injections (eg, intraocular injections for wet macular degeneration).
31. Has a history of hypersensitivity or allergies to methotrexate, vedolizumab, adalimumab, or their components.
32. Has a medical history that contraindicates the use of vedolizumab, adalimumab, or methotrexate as per each drug's package insert.
33. Has conditions which, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
34. Has a history of any lymphoma or lymphoproliferative disease.
35. Has a history of congestive heart failure (New York Heart Association class III/IV) or unstable angina.
36. Has renal insufficiency, ascites, pleural effusion, or underlying liver disease.
37. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
38. Has had gastric bypass surgery.
39. Has symptoms of shortness of breath and cough and/or a diagnosis of clinically significant lung disease.
40. Has a history of malignancy, except for the following: adequately-treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to Screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to Screening. Participants with a remote history of malignancy (eg, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.
41. Has a history of any major neurological disorders, including stroke, central nervous system demyelinating disease, brain tumor, or neurodegenerative disease.
42. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of study drug.
43. Has a history of pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia (WBC count <3 × 10^9/L), thrombocytopenia (platelet count <100 × 10/L), or significant anemia (hemoglobin level <8 g/dL).
44. Has rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
45. Has any of the following laboratory abnormalities during the Screening period:
1. Hemoglobin level <8 g/dL.
2. WBC count <3 x 10^9/L.
3. Lymphocyte count <0.5 x 10^9/L.
4. Platelet count <100 x 10^9/L or >1200 x 10^9/L.
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 the upper limit of normal (ULN).
6 .Alkaline phosphatase >1.5 x ULN.
7. Renal dysfunction (serum creatinine concentration greater than 1.5 mg per deciliter [133 µmol per liter]) or estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m^2 at Screening Note: Retesting laboratory values during the screening interval may be considered with consultation from the Medical Monitor.
46. Has a history of high alcohol consumption (more than 7 drinks per week), a history of prior alcohol abuse within 5 years prior to enrollment, has alcoholic liver disease, has withdrawal symptoms, or a history of illicit drug use.
47. Has an active psychiatric problem that, in the investigator's opinion, may interfere with compliance with study procedures.
48. Is unable to attend all the study visits or comply with study procedures.
49. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g, spouse, parent, child, sibling) or may consent under duress.
50. Body mass index is >35.
51. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 6 months after participating in this study; or intending to donate ova during such time period.
52. If male, the participant intends to father a child or donate sperm during the course of this study or for 6 months thereafter.

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973-630-2232
research@atlantichealth.org

More info:
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More Detail
Bowel Disease
Open to Enrollment

Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome

The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and...

Investigator:
Razvan Arsenescu, MD

Irritable Bowel Syndrome (IBS).

ALP Cal01

Sponsor:
Buhlmann Laboratories AG

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 22 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample

Study Population

100 adult subjects with Inflammatory Bowel Disease or Irritable Bowel Syndrome each have provided a stool sample. In addition, 50 pediatric subjects, age 2 years to 21 years, 25 subjects in each diagnostic group (IBD, IBS) will be enrolled. Recruitment of 120 normal subjects who will provide samples.

Inclusion Criteria:
1. Adults or pediatric patients evaluated by a gastroenterological service for investigation of possible inflammatory intestinal disease or IBS. Patients are referred for sub-specialty evaluation of symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia.
◦IBD: Eligible subjects will be analyzed as patients with IBD after a confirmed diagnosis of Inflammatory Bowel Disease (CD, UC, or Indeterminate Colitis), based on endoscopy and confirmed by histology of biopsies taken during endoscopy.
◦IBS: Eligible candidate subjects can also include patients who are self-referred with the relevant constellation of complaints. Eligible subjects will be enrolled after having a diagnosis of IBS based on the Rome III criteria confirmed by negative endoscopy including the colon and terminal ileum.
◦other GI Disorders: Eligible subjects will be enrolled after having a diagnosis of a gastrointestinal disorder other than IBD or IBS, confirmed by endoscopy results and other appropriate diagnostic studies.
◦Healthy Controls: Adults (≥22) with no abdominal complaints and no history of IBS, IBD or other chronic intestinal disorder, confirmed by medical history and physical examination at enrolment.
2. Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of age (pediatric samples).
3. IBD patients whose diagnostic endoscopy occurred within the previous month.
4. Individuals able to understand the study and the tasks required, and who sign the Informed Consent Form (adult subjects; ICF) or whose parent/guardian provides consent (ICF) and, if age 7-to-18 years of age, who provide assent (pediatric subjects).

Exclusion Criteria:
1. Individuals unable or unwilling to provide a stool specimen.
2. Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal disease
3. Individuals receiving chemotherapy or systemic immunosuppressive drugs.
4. Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or H2-receptor antagonists.
5. Individuals with previously diagnosed Inflammatory Bowel Disease managed with immunomodulators, 5-ASA (5-aminosalicylic acid) or biologic therapies or who have undergone a surgical resection or diversion procedure.
6. Individuals who have taken NSAIDs (nonsteroidal anti-inflammatory drugs), including aspirin, on 7 or more days during the 2 weeks before providing the sample.

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Contact:
973-630-2232
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Bowel Disease
Open to Enrollment

Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

Investigator:
Razvan Arsenescu, MD
MLN-0002_401

Sponsor:
Takeda Development Center Americas, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population

Participants with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating Entyvio or another biologic agent. Participants may be biologic-naive or have prior use of a biologic agent

Inclusion Criteria:
1. Signed informed consent, by the participant or a legally acceptable representative.
2. Aged at least 18 years.
3. Initiating vedolizumab or another biologic agent for UC or CD.
4. Signed release form, by the participant or a legally acceptable representative, permitting abstraction of the participant's medical records at Baseline and during participation in the study.

Exclusion Criteria:
1. The participant is enrolled in a clinical trial in which treatment for CD or UC is managed through a protocol.
2. Prior treatment with vedolizumab.
3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

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Contact:
973-630-2232
research@atlantichealth.org

More info:
ClinicalTrials.gov