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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-12

Study Completion Date

2017-11-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adalimumab

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

Group Type OTHER

Adalimumab

Intervention Type DRUG

Adalimumab pre-filled syringe, administered by subcutaneous injection

Interventions

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Adalimumab

Adalimumab pre-filled syringe, administered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Humira ABT-D2E7

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No