Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115

AbbVie

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02185014

2013-004034-15 (EudraCT Number)

M14-347

Details and patient eligibility

About

The purpose of this study is to evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in participants with Crohn's disease.

Enrollment: 252 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the Week 12 ileocolonoscopy.

Exclusion criteria

• If the Week 12 (Study M14-115; NCT02185014) colonoscopy shows evidence of dysplasia or malignancy.
• Subject is not in compliance with prior and concomitant medication requirements throughout M14-115 (NCT02185014).
• Subject who developed active Tuberculosis (TB) during M14-115 (NCT02185014), or subject who is non compliant with prophylaxis for latent tuberculosis (TB) initiated per M14-115 (NCT02185014) procedures.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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252 participants in 1 patient group

Adalimumab

Other group

Description:

Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.

Treatment:

Drug: Adalimumab