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

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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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adalimumab

Drug

Adalimumab pre-filled syringe, administered by subcutaneous injection

Other names: Humira, ABT-D2E7

Primary outcomes

Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0

Time frame: Week 40

Endoscopic improvement defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4 and at least a 2-point reduction compared with Study M14-115 (NCT02185014) Baseline and no subscore greater than 1 in any individual endoscopic variable. The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The Total Score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Nonresponder imputation (NRI) was used for missing data.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jul 9, 2014
Registry last updated: Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed