P11-282 LEGACY Version Amendment 3
Research type
Research Study
Full title
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)
IRAS ID
181394
Contact name
John Paul Seenan
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Clinicaltrials.gov Identifier
LEGACY , 3524; Clintrials.gov , NCT01848561
Duration of Study in the UK
12 years, 4 months, 16 days
Research summary
This study is taking place at a number of locations in various countries around the world. It will capture information regarding the routine care of adult patients (18 years or older) who have moderately to severely active Ulcerative Colitis (UC). These patients will be receiving treatment with either Humira® or other immunosuppressant drugs [azathioprine (AZA) or 6-mercaptopurine (6-MP)].
The study will review the long-term safety and effectiveness of Humira® over a ten year period. The study (registry) will only monitor the safety and effectiveness of the drugs as they are regularly used by your doctor. There will be no change to any treatment as a result of the study.
Approximately 5500 patients around the world will be monitored while using Humira and approximately 2750 patients will be monitored on other immunosuppressant drugs used to treat UC.
As well as reviewing the safety and effectiveness of Humira®, the impact of any interruptions to treatment will also be assessed.
This registry study is part of a postmarketing commitment from AbbVie to the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0519
Date of REC Opinion
15 Jul 2015
REC opinion
Further Information Favourable Opinion