Phase 3
N=135
Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00348283 ↗Enrolled (actual)
135
Serious AEs
14.8%
Results posted
Feb 2010
Primary outcome: Primary: Number of Subjects Without Mucosal Ulceration at Week 12 — 8; 17 Subjects — p=0.056
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological); placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Without Mucosal Ulceration at Week 12 |
8; 17 | 0.056 |
| SECONDARY Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12 |
18; 30 | 0.021 sig |
| SECONDARY Number of Subjects Without Mucosal Ulceration at Week 52 |
0; 15 | <0.001 sig |
| SECONDARY Number of Subjects With Clinical Remission (CDAI < 150) at Week 52 |
6; 21 | 0.001 sig |
| SECONDARY Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52 |
0; 7 | 0.150 |
| SECONDARY Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52 |
3; 19 | <0.001 sig |
Summary
The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Crohn's Disease for greater than 4 months.
- A diagnosis of ileocolonic Crohn's Disease confirmed by endoscopy or radiologic evaluation within 3 years of Baseline.
- For subjects who have had operations in the ileocolonic region of the intestine after documented diagnosis of ileocolonic disease, postoperative recurrence of the disease must be documented.
- Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3 in at least one of the five segments of the colon on the Ulcerated Surface subscore of the Simple Endoscopic Score for Crohn's Disease (SES-CD).
- Crohn's Disease Activity Index (CDAI) score of >= 220 and = 18 and 40 mg/day (or equivalent).
- Subjects on budesonide > 9 mg/day.
- Subjects with any prior exposure to Tysabri® (natalizumab).
- Subjects with a previous history of dysplasia of the gastrointestinal tract, or found to have dysplasia in any biopsy performed during the Screening endoscopy.
Data sourced from ClinicalTrials.gov (NCT00348283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.