Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

AbbVie

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02065570

M14-115

2013-001746-33 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

Enrollment: 514 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.
• Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
• Mucosal ulceration on endoscopy.

Exclusion criteria

• Subject with ulcerative colitis or indeterminate colitis.
• Subject who has had surgical bowel resections in the past 6 months or is planning resection.
• Subjects with an ostomy or ileoanal pouch.
• Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
• Subject who has short bowel syndrome.
• 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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514 participants in 4 patient groups

Induction: Standard Induction Dose

Experimental group

Description:

Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.

Treatment:

Drug: Adalimumab

Drug: Placebo

Induction: Higher Induction Dose

Experimental group

Description:

Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.

Treatment:

Drug: Adalimumab

Maintenance: Clinically Adjusted (CA) Regimen

Experimental group

Description:

Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to every week (ew) starting as early as Week 14 and up to Week 54 based on Crohn's Disease Activity Index (CDAI) or high-sensitivity C-reactive protein (hs-CRP) values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.

Treatment:

Drug: Adalimumab

Maintenance: Therapeutic Drug Monitoring (TDM) Regimen

Experimental group

Description:

At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM will be determined by protocol-established dose adjustment criteria. Doses will be determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 will receive 40 mg ew.

Treatment:

Drug: Adalimumab