Health Condition 1: null- Crohnâ??s disease.
Conditions
Interventions
Intervention1: Experimental: 5mg BID: Drug: CP-690,550
oral tablets twice daily
Duration: 48 weeks
Intervention2: Experimental: 10mg BID: Drug: CP-690,550
oral tablets twice daily
Duration: 48 week
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
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
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse eventsTimepoint: Time Frame:52 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| CDAI scores over time and change from baseline in CDAI scores.Timepoint: Time Frame: WEEK 48;Corticosteroid use over time.Timepoint: Time Frame: WEEK 48;Serum CRP and fecal calprotectin over time and change from baseline in CRP and fecal calprotectinTimepoint: Time Frame: WEEK 48;Sustained clinical remission is defined as being in clinical remission at both Week 24 and Week 48.Timepoint: Time Frame: WEEKS 24 AND 48;The median time to relapse among subjects in clinical remission at baseline. Relapse is defined as increase in CDAI of 100 points from the baseline and an absolute CDAI score of 220 points.Timepoint: Time Frame: WEEK 48;The proportion of all enrolled subjects in clinical remission and sustained clinical remission at Week 48.Timepoint: Time Frame: WEEK 48;The proportion of subjects achieving a steroid-free clinical remission at Week 48 among subjects on steroids at baseline.Timepoint: Time Frame: WEEK 48;The proportion of subjects in clinical remission and sustained clinical remission among subjects in clinical response (CDAI-100 response from Study A3921083 baseline) or clinical remission at A3921086 baseline.Timepoint: Time Frame: WEEK 48;The proportions of subjects in clinical remission and sustained clinical remission among subjects in clinical remission at A3921086 baseline.Timepoint: Time Frame: WEEK 48 | — |
Countries
Australia, Austria, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Japan, Netherlands, Republic of Korea, Romania, South Africa, Spain, Ukraine, United States of America
Contacts
Public ContactPriya D Souza
Pfizer Limited
Outcome results
None listed