A Study of Abatacept in Patients With Active Crohn's Disease

Summary

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

Timeline

Start

2006-12

Primary completion

2009-11

Completion

2009-11

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor Decision”

registry ABA 30/~10 mg/kg, IP vs Placebo, IP; p = 0.611; Risk Ratio (RR) 1.2 (95% CI 0.6 to 2.4) NCT00406653 ↗

paper vs 14.4% receiving placebo (P = .611, P = .311, and P = .812, respectively). PMID 22504093 ↗

Publications

• Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, Bressler B, Geboes K, Schreiber S, Aranda R, Gujrathi S, Luo A, Peng Y, Salter-Cid L, Hanauer SB. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology. 2012 Jul;143(1):62-69.e4. doi: 10.1053/j.gastro.2012.04.010. Epub 2012 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	3 mg/kg	Intravenous
Subject	Abatacept	Other / unclassified	10 mg/kg	Intravenous
Subject	Abatacept	Other / unclassified	30 mg/kg	Intravenous

Indications