A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceratio
- Conditions
- Crohn's diseaseMedDRA version: 18.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-001746-33-FR
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 514
1)Subject is between the ages of 18 to 75 years
2) Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period
3) Active CD with a Crohn's Disease Activity Index (CDAI) = 220 and = 450 despite treatment with oral corticosteroids and/or immunosuppressants
4) Mucosal ulceration on endoscopy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1) Subject with ulcerative colitis or indeterminate colitis
2) Subject who has had surgical bowel resections within the past 6 months or is planning resection
3) Subject with an ostomy or ileoanal pouch
4) Subject with bowel stricture or abdominal or peri-anal abscess
5) Subject who has short bowel syndrome
6) Chronic recurring infections or active TB
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission at Week 4 and endoscopic improvement at Week 12 in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.;Secondary Objective: • To assess the safety and efficacy of two adalimumab induction regimens in reducing signs and symptoms of Crohn's disease at Week 12.<br>• To assess pharmacokinetics (PK) and immunogenicity of two adalimumab induction regimens following subcutaneous (SC) administration.<br>;Primary end point(s): Proportion of subjects who achieve clinical remission at Week 4 and proportion of subjects who achieve endoscopic response at Week 12.;Timepoint(s) of evaluation of this end point: Week 4 and Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Clinical remission at Week 12. <br>2. Proportion of subjects who discontinued corticosteroid use and<br>achieved clinical remission at Week 12.<br>3. Proportion of subjects with clinical response at Week 4.<br>4. Proportion of subjects with clinical response at Week 12.<br>5. Proportion of subjects with endoscopic response at Week 12.<br>6. Change in IBDQ from Baseline at Week 4. <br>7. Change in IBDQ from Baseline at Week 12.<br>;Timepoint(s) of evaluation of this end point: Week 4 and 12 depending on the endpoints