Phase 3
Completed N=82
A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
Source: ClinicalTrials.gov NCT00445432 ↗Enrolled (actual)
82
Serious AEs
43.5%
Results posted
Jun 2010
Primary outcomePrimary: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment — 8; 2 Participants
Summary
To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment |
8; 2 | — |
| SECONDARY Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment |
9; 2; 10 | — |
| SECONDARY Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment |
8; 2; 8 | — |
| SECONDARY Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment |
-83.7; -9.1 | — |
| SECONDARY Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment |
5 | — |
| SECONDARY Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment |
-0.8; -0.2 | — |
| SECONDARY Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment |
27.8; 1.8 | — |
| SECONDARY Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment |
4.4; 0.2 | — |
| SECONDARY Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment |
9.6; 0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who successfully enrolled in and completed the M04-729, (NCT00445939) study
Exclusion Criteria
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Data sourced from ClinicalTrials.gov (NCT00445432). 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.