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

Sponsor
AbbVie
Study ID
NCT02185014
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab pre-filled syringe, administered by subcutaneous injection

Study Details

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.

Key Dates

Start date
Aug 12, 2014
Status verified
Oct 2018
Primary completion
Nov 3, 2017
Completion
Nov 3, 2017

Study Design

Enrollment
252 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0 [ Time Frame: Week 40 ]

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