A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

Summary

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).

Timeline

Start

2011-10

Primary completion

2015-02

Completion

2015-03

Outcome

Missed primary endpoint

paper Primary efficacy endpoints were not significantly different from placebo, although there was evidence of a minor treatment effect. PMID 28209624 ↗

registry analysis (superiority or other test); Placebo vs Tofacitinib 5 mg BID; p = 0.3249; Mean Difference (Final Values) 6.86 (95% CI -7.64 to 21.36); Cochran-Mantel-Haenszel NCT01393626 ↗

registry analysis (superiority or other test); Placebo vs Tofacitinib 10 mg BID; p = 0.3916; Mean Difference (Final Values) 6.36 (95% CI -8.09 to 20.80); Cochran-Mantel-Haenszel NCT01393626 ↗

Publications

• Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tofacitinib	Small molecule	5 mg	Oral
Subject	Tofacitinib	Small molecule	10 mg	Oral

Indications