A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical
 remission in Japanese subjects with Crohn's disease.
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.
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