Overview

This trial is active, not recruiting.

Condition ulcerative colitis
Treatment adalimumab
Phase phase 3
Target TNF-alpha
Sponsor AbbVie (prior sponsor, Abbott)
Start date November 2007
End date September 2016
Trial size 800 participants
Trial identifier NCT00573794, 2007-004157-28, M10-223

Summary

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
adalimumab ABT-D2E7
Prefilled syringes 40 mg EOW subcutaneous and prefilled syringes 40 mg weekly subcutaneous

Primary Outcomes

Measure
Change from Baseline in Mayo Scores
time frame: Week 48, Week 96, Week 144, Week 192, Week 240; Week 292 Week 340, Week 388, Week 436,
Change from Baseline in Partial Mayo Scores
time frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292 Week 340 and Week 388

Secondary Outcomes

Measure
Change from Baseline in IBDQ & SF-36
time frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292 Week 340 and Week 388
Change from Baseline in Work Productivity and Activity Impairment Questionnaire
time frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292; Week 340; Week 388, Week 436;
AEs, Laboratory data, physical exams, and vital signs
time frame: Throughout course of the study
Cumulative number of unscheduled outpatient visits
time frame: Throughout course of the study

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Subject must have successfully enrolled and completed either the M06-826 study or the M06-827 study - Subject is judged to be in generally good health as determined by the principal investigator Exclusion Criteria: - Subject has not responded to weekly adalimumab therapy in M06-826 or M06-827 - Subject considered by the investigator, for any reason, to be an unsuitable candidate - Female subject who is pregnant or breast-feeding or considering becoming pregnant

Additional Information

Official title A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AbbVie.