A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470599

A3921086

2011-003622-27 (EudraCT Number)

Details and patient eligibility

About

The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.

Enrollment: 150 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
• Women of childbearing potential must test negative for pregnancy prior to study enrolment.
• Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

Exclusion criteria

• Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
• Subjects who were discontinued from the A3921084 study due to an adverse event.
• Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

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