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
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adalimumab
Arm Description
Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02185014
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 12, 2014 (undefined)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab
Arm Type
Other
Arm Description
Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira, ABT-D2E7
Intervention Description
Adalimumab pre-filled syringe, administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0
Description
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.
Time Frame
Week 40
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://rxabbvie.com/
Description
Related Info
Learn more about this trial
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
We'll reach out to this number within 24 hrs