CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 592 enrolled
Drug / intervention
adalimumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00573794
NCT00573794Phase 3Completed
CompareCT.gov

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

AbbVie (prior sponsor, Abbott)·interventional·Posted Dec 14, 2007·Updated Jul 7, 2021

In Brief

A Phase 3 clinical trial evaluating adalimumab for Ulcerative Colitis. Completed, enrolled 592 participants.

Detailed Summary

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2007
Enrollment StartNov 28, 2007
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9.0 yearsPosted 18.6 years ago

Interventions

adalimumabbiological

adalimumab prefilled syringes administered as subcutaneous injection EW or EOW