B0151005 Crohn's disease ANDANTE II study
Research type
Research Study
Full title
A Multicenter Open-Label Extension Study For Subjects Who Participated In Study B0151003 (Andante II)
IRAS ID
86291
Contact name
John Mansfield
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2011-000722-30
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Crohn??s disease (CD) is a chronic, inflammatory disease of the gastrointestinal (GI) tract. Although the exact cause of CD remains unclear, over production of inflammatory agents, such as cytokines, may be potential targets for treatment. Additional treatments are needed for CD despite currently available therapies. This is an open-label, safety extension of study B0151003 (a proof of concept study to determine the efficacy and safety of a monoclonal antibody, study drug, PF-04236921) in subjects with moderate to severe Crohn??s Disease who have failed to improve with anti-TNF treatment. Men and women between the ages of 18-75 who have completed the 12-week double blind induction period of study B0151003 will be permitted to start open label active treatment in B0151005. Subjects will receive an injection of 50mg of study drug administered under the skin. The first injection will be administered at the baseline visit and then every 8 weeks through Week 40 (Visit 11). The dose may be increased to 100 mg in subjects who do not respond or relapse. The final interval visit is week 48, and no treatment will be administered. Subjects who complete the study or who do not respond to the higher dose will terminate dosing and enter the follow-up period. The follow-up period will continue for 28 weeks (36 weeks from final dose). At Week 76, subjects will undergo the final study evaluation.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
11/NE/0301
Date of REC Opinion
12 Apr 2012
REC opinion
Further Information Favourable Opinion