The Safety And Efficacy Of Maintenance Therapy With CP-690,550

Pfizer

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01393899

A3921084

2011-001754-28 (EudraCT Number)

Details and patient eligibility

About

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
• Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
• Women of childbearing potential must test negative for pregnancy prior to study enrolment.

Exclusion criteria

• Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
• Subjects likely to require any type of surgery during the study period.
• Fecal culture/toxin assay indicating presence of pathogenic infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups, including a placebo group

Placebo BID

Placebo Comparator group

Treatment:

Drug: Placebo

5mg BID

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

10mg BID

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550