Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

AbbVie

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis (UC)

Treatments: Drug: Adalimumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02065622

M14-033

2013-001682-16 (EudraCT Number)

Details and patient eligibility

About

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

Enrollment: 952 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
• Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.

Exclusion criteria

• Subject with Crohn's disease (CD) or indeterminate colitis (IC).
• Current diagnosis of fulminant colitis and/or toxic megacolon.
• Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
• Chronic recurring infections or active tuberculosis (TB).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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952 participants in 5 patient groups

Induction (Main Study + Japan Sub-study): I-SD

Experimental group

Description:

Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.

Treatment:

Other: Placebo

Drug: Adalimumab

Induction (Main Study + Japan Sub-study): I-HD

Experimental group

Description:

Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4, and 40 mg at Week 6.

Treatment:

Drug: Adalimumab

Maintenance (Main Study + Japan Sub-study): M-SD

Experimental group

Description:

Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.

Treatment:

Other: Placebo

Drug: Adalimumab

Maintenance (Main Study + Japan Sub-study): M-HD

Experimental group

Description:

Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.

Treatment:

Drug: Adalimumab

Maintenance (Main Study): TDM Regimen

Experimental group

Description:

Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments.

Treatment:

Other: Placebo

Drug: Adalimumab