A Multi-Center, Randomized, Double-Blind, Placebo ??? Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.
- Conditions
- Crohn's DiseaseInflammatory disorder affecting the lining of the gastrointestinal tract1001796910003816
- Registration Number
- NL-OMON29817
- Lead Sponsor
- Abbott
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 7
1. Diagnosis of Crohn's Disease for greater than 4 months.
2. A diagnosis of ileocolonic Crohn's Disease confirmed by endoscopy or radiologic evaluation within 3 years of Baseline.
3. For subjects that have had operations in the ileocolonic region of the intestine after documented diagnosis of ileocolonic disease, postoperative recurrence of the disease must be documented.
4. Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3 on the Ulcerated Surface subscore of the SES-CD.
5. Crohn's Disease Activity Index (CDAI) score of ><= 220 and <<= 450.
6. Males and females ><= 18 and ><= 75 years of age at the Baseline visit.
7. Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.
8. Subjects must agree to undergo up to 4 endoscopies.
1. History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix.
2. History of listeria, human immunodeficiency virus (HIV), Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or untreated TB.
3. Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the investigator and Abbott Medical Monitor.
4. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
5. Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
6. Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded.
7. Previous treatment with adalimumab or previous participation in an adalimumab clinical study.
8. Subjects on prednisone >40 mg/day (or equivalent).
9. Subjects on budesonide >9 mg/day.
10. Subjects with any prior exposure to Tysabri® (natalizumab).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable is the presence or absence of mucosal ulceration<br /><br>by endoscopy. The primary outcome analysis will be a comparison of the<br /><br>proportions of subjects without mucosal ulceration on endoscopy in the<br /><br>adalimumab and placebo groups at Week 12.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy variables will be:<br /><br>- Crohn's Disease Endoscopic Index of Severity (CDEIS) scores,<br /><br>- the Simple Endoscopic Score for Crohn's Disease (SES-CD) and ulcer counts<br /><br>- CDAI score<br /><br>- number of subjects discontinued from steroids<br /><br>- total IBDQ scores<br /><br>- WPAI scores<br /><br>- SF * 36<br /><br>- dimension scores<br /><br>- Unscheduled Outpatient Visits<br /><br>- Emergency Room Visits<br /><br>- Hospitalizations Questionnaire</p><br>