Remission in Subjects With Crohn's Disease, 1 Year Phase (CLASSICII)

Abbott

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Biological: Double-blind (DB) adalimumab placebo; Biological: DB adalimumab 40 mg eow; Biological: DB adalimumab 40 mg ew; Biological: OL adalimumab 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00055497

M02-433

Details and patient eligibility

About

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.

Full 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).

Enrollment: 276 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Patient must have successfully completed the induction study NCT00055523
• Diagnosis of Crohn's disease
• Willing and able to give informed consent

Exclusion:

• Diagnosis of ulcerative colitis
• Pregnancy or breastfeeding
• Previous use of infliximab or other anti-TNF antagonists
• Previous history of active tuberculosis or listeria infection
• Previous history of cancer other than successfully treated skin cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 4 patient groups, including a placebo group

Double-blind (DB) adalimumab placebo

Placebo Comparator group

Description:

Double-blind nonactive matching subcutaneous injection

Treatment:

Biological: Double-blind (DB) adalimumab placebo

Double-blind adalimumab 40 mg every other week (eow)

Experimental group

Description:

Double-blind adalimumab 40 mg eow by subcutaneous injection

Treatment:

Biological: DB adalimumab 40 mg eow

Double-blind adalimumab 40 mg every week (ew)

Experimental group

Description:

Double-blind adalimumab 40 mg every week by subcutaneous injection

Treatment:

Biological: DB adalimumab 40 mg ew

Open-label adalimumab 40 mg

Experimental group

Description:

Open-label adalimumab 40 mg eow or ew by subcutaneous injection

Treatment:

Biological: OL adalimumab 40 mg