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

(CLASSICII Trial)

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Abbott

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Patient must have successfully completed the induction study NCT00055523

Diagnosis of Crohn's disease

Willing and able to give informed consent

Treatment Details

Interventions

• Adalimumab (Monoclonal Antibodies)

Participant Groups

Group I: Open-label adalimumab 40 mg Experimental Treatment 1 Intervention

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

Group II: Double-blind adalimumab 40 mg every week (ew) Experimental Treatment 1 Intervention

Double-blind adalimumab 40 mg every week by subcutaneous injection

Group III: Double-blind adalimumab 40 mg every other week (eow) Experimental Treatment 1 Intervention

Double-blind adalimumab 40 mg eow by subcutaneous injection

Group IV: Double-blind (DB) adalimumab placebo Placebo Group 1 Intervention

Double-blind nonactive matching subcutaneous injection

Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

🇺🇸 Approved in United States as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis
• Hidradenitis suppurativa

🇨🇦 Approved in Canada as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

🇯🇵 Approved in Japan as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Altoona Center for Clinical Research Duncansville, PA

Gastroenterology Specialties, P.C. Lincoln, NE

Atlanta Gastroenterology Assoc. Atlanta, GA

Northwest Gastroenterologists, S.C. Arlington Heights, IL

More Trial Locations

Who Is Running the Clinical Trial?

Abbott Lead Sponsor

References