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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Biological: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00573794

M10-223

2007-004157-28 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 592 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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592 participants in 1 patient group

Adalimumab 40 mg EOW/EW

Experimental group

Description:

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.

Treatment:

Biological: adalimumab