Remission in Subjects With Crohn's Disease, 1 Year Phase
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of
      clinical remission up to 56 weeks in participants with Crohn's disease who participated in
      NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with
      Crohn's disease up to 56 weeks.
    

Detailed description: 
      Study NCT00055497 was designed to evaluate the efficacy and safety of adalimumab in the
      maintenance of clinical remission in patients with Crohn's disease (CD). The study consisted
      of 2 phases: 1. the first year phase lasting until Week 56 and consisting of a randomized,
      double-blind (DB), placebo-controlled portion (NCT00055497) and of a concomitant open label
      (OL) portion, and 2. a long-term extension phase (NCT01070303) that lasted 264 additional
      weeks (Week 56 to Week 320).

      Potential participants were screened at the time of enrollment in the lead-in, induction
      therapy study (NCT00055523). Participants who completed the lead-in study, NCT00055523, were
      eligible to participate in the rollover study, NCT00055497.

      In Study NCT00055497, all participants received 40 mg of adalimumab subcutaneously (SC) at
      Baseline (Week 0) and Week 2 of Study NCT00055497. Baseline of Study NCT00055497 is
      synonymous with NCT00055523 Week 4. At Week 4 of Study NCT00055497, participants were
      randomized based on their clinical remission status at Baseline and Week 4 of Study
      NCT00055497. Participants who demonstrated clinical remission (defined as a Crohn's Disease
      Activity Index [CDAI] score < 150 points) at Baseline of Study NCT00055497 and who remained
      in clinical remission at Week 4 of Study NCT00055497 (those participants constituted the
      randomized analysis set) were randomized to receive 1 of 3 blinded treatments: adalimumab 40
      mg every other week (eow), adalimumab 40 mg every week (ew), or placebo. Participants who did
      not demonstrate clinical remission at Baseline of Study NCT00055497, or who were no longer in
      clinical remission at Week 4 of Study NCT00055497 were assigned to receive OL adalimumab 40
      mg eow; those participants constituted the OL analysis set. At any time during Study
      NCT00055497, participants receiving OL adalimumab 40 mg SC eow who developed a flare or were
      non-responders during OL treatment could have had his/her dose increased to 40 mg SC weekly.
      Participants who were documented as having completed Week 56 are counted in the study
      completion total.

      After 1 year (Week 56), participants who met eligibility criteria for the long-term extension
      phase (NCT01070303) were switched to OL adalimumab 40 mg subcutaneous (SC) eow, and
      participants previously in the OL treatment group of Study NCT00055497 continued on their
      previous OL adalimumab dose (adalimumab 40 mg SC eow or every week).
    

Intervention name(s): Double-blind (DB) adalimumab placebo; DB adalimumab 40 mg eow; DB adalimumab 40 mg ew; OL adalimumab 40 mg
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Double-blind nonactive matching subcutaneous injection; Double-blind adalimumab 40 mg every other week by subcutaneous injection; Double-blind adalimumab 40 mg every week by subcutaneous injection; Open-label adalimumab every other week or every week by subcutaneous injection
Other intervention name(s): Humira®; Humira®; Humira®; Humira®
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment