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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. 

Showing 3 Results for ulcerative colitis

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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

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