Phase 3
Completed N=90
A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
Source: ClinicalTrials.gov NCT00445939 ↗Enrolled (actual)
90
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 — 11; 6; 3 Particpants
Summary
The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 |
11; 6; 3 | — |
| SECONDARY Clinical Remission (CDAI < 150) at Week 2 |
6; 5; 1 | — |
| SECONDARY Clinical Response (CR-70 and CR-100) in Period A |
15; 17; 4; 23; 20; 7 | — |
| SECONDARY Clinical Response (CR-70 and CR-100) in Period B |
1; 4; 9; 3; 5; 12 | — |
| SECONDARY Clinical Remission (CDAI <150) at Week 6 and Week 8 |
0; 1; 2; 0; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450
- If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy
Exclusion Criteria
- Ulcerative colitis or indeterminate colitis
- History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
- Body weight is below 30 kg
- Surgical bowel resections within the past 6 months
- Females who are pregnant or breast-feeding or considering becoming pregnant during the study
Data sourced from ClinicalTrials.gov (NCT00445939). 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. Informational only — not medical advice.