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A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: adalimumab (Biological); Placebo (Other)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Kazuko Kobayashi, Study Director, Affiliation: Abbott

Summary

To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.

Clinical Details

Official title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment

Secondary outcome:

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

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

Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment

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

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

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

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

Detailed description: This was a Phase 2/3, multicenter, randomized, double-blind (DB), placebo-controlled, two-arm, efficacy, safety, and pharmacokinetic study designed to demonstrate the effectiveness of adalimumab in Japanese patients with moderate to severe Crohn's Disease (CD). All participants who had completed Study M04-729 (NCT00445939), the lead-in adalimumab induction therapy study, were eligible for this study. Participants who rolled over into this study received either DB treatment (adalimumab or placebo) or open-label (OL) treatment with adalimumab. Crohn's Disease Activity Index (CDAI) was used to determine participants who were responders and participants who were in clinical remission. CDAI documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. It yields a total score >= 0 and without upper limit. Baseline scores in the study ranged from 221 to 448. Low score=less severe CD activity. Decrease in score indicates improvement. Clinical remission is a CDAI score < 150. Clinical response-70 (CR-70) = decrease in CDAI ≥ 70 points from lead-in study Baseline score. Clinical response-100 (CR-100) = decrease in CDAI ≥ 100 points from lead-in study Baseline score. Participants who had CR-70 response at Week 4 of the induction study were randomized into 1 of 2 treatment groups (double-blind adalimumab 40 mg every other week or adalimumab placebo

every other week) using 2 stratification factors - CDAI category (CDAI less than 150 and

CDAI 150 or higher) and presence/absence of fistula at Week 0 of this study. The double-blind treatment was to last from Week 0 to Week 52. Any time at or after Week 4 of this study, if a participant's disease flared (defined as a recurrence of very active disease, specifically an increase in CDAI when compared to Week 0 in this study of ≥ 70 points and a CDAI above 220) during the double-blind treatment period, the participant was allowed to move to OL treatment. At Week 52, all participants still receiving DB treatment were to be moved to open-label treatment and could continue in the study until adalimumab is approved for commercial use in Japan. Participants who did not respond by Week 4 in the induction study and participants who had disease flare during DB treatment of this study entered OL treatment and received adalimumab 40 mg every other week. At or after Week 4 of this study, if a participant in the open-label treatment group had a disease flare or if the participant was still not responding to treatment, the participant was allowed to dose escalate to adalimumab 80 mg every other week. Participants who entered open-label treatment were to be allowed to continue on open-label adalimumab until adalimumab is approved for commercial use in Japan. The study is complete. Results of this study are reported for endpoints at Week 52 (end of the DB treatment period) for subjects who received DB treatment (adalimumab or placebo) or OL adalimumab treatment and for endpoints at Week 148 for all subjects who received at least one dose of adalimumab in this study.

Eligibility

Minimum age: 15 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Site Ref # / Investigator 46965, Aichi, Japan

Site Ref # / Investigator 46977, Aichi, Japan

Site Ref # / Investigator 46978, Aichi, Japan

Site Ref # / Investigator 46979, Aichi, Japan

Site Ref # / Investigator 46922, Chiba, Japan

Site Ref # / Investigator 46974, Chiba, Japan

Site Ref # / Investigator 46970, Ehime, Japan

Site Ref # / Investigator 46971, Fukuoka, Japan

Site Ref # / Investigator 46985, Fukuoka, Japan

Site Ref # / Investigator 46986, Fukuoka, Japan

Site Ref # / Investigator 46987, Fukuoka, Japan

Site Ref # / Investigator 46968, Hiroshima, Japan

Site Ref # / Investigator 46973, Hokkaido, Japan

Site Ref # / Investigator 6881, Hokkaido, Japan

Site Ref # / Investigator 46982, Hyogo, Japan

Site Ref # / Investigator 46969, Kagawa, Japan

Site Ref # / Investigator 46927, Kanagawa, Japan

Site Ref # / Investigator 46984, Kochi, Japan

Site Ref # / Investigator 46981, Kyoto, Japan

Site Ref # / Investigator 46921, Miyagi, Japan

Site Ref # / Investigator 46983, Okayama, Japan

Site Ref # / Investigator 46966, Osaka, Japan

Site Ref # / Investigator 46967, Osaka, Japan

Site Ref # / Investigator 46980, Shiga, Japan

Site Ref # / Investigator 46964, Shizuoka, Japan

Site Ref # / Investigator 46923, Tokyo, Japan

Site Ref # / Investigator 46924, Tokyo, Japan

Site Ref # / Investigator 46975, Tokyo, Japan

Site Ref # / Investigator 46976, Tokyo, Japan

Additional Information

Starting date: March 2007
Last updated: February 1, 2012

Page last updated: August 23, 2015

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