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

Crohn's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185014
• Other study ID #: M14-347
• Secondary ID: 2013-004034-15
• Status: Completed
• Phase: Phase 3
• Start date: August 12, 2014
• Est. completion date: November 3, 2017

Study information

• Verified date: October 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Adalimumab
Adalimumab pre-filled syringe, administered by subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0	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.	Week 40

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