Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-28

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Open-Label Adalimumab for Ulcerative Colitis Patients

NCT00421642

Ulcerative Colitis

COMPLETED PHASE1

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

NCT00385736

Ulcerative Colitis

COMPLETED PHASE3

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

NCT00408629

Ulcerative Colitis

COMPLETED PHASE3

Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions

NCT02738125

Ulcerative Colitis (UC)

COMPLETED

Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

NCT02632175

Ulcerative Colitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adalimumab 40 mg EOW/EW

Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

adalimumab prefilled syringes administered as subcutaneous injection EW or EOW

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adalimumab

adalimumab prefilled syringes administered as subcutaneous injection EW or EOW

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-D2E7 HUMIRA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629)
* 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 (NCT00385736) or M06-827 (NCT00408629)
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No