To Evaluate SAFETY AND EFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHNâ??S DISEASE

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHNâ??S DISEASE - Not Applicable

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/01/003294

Enrollment

275

Registered

2013-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Crohnâ??s disease

Interventions

Intervention1: Experimental: 5mg BID: Drug: CP-690,550 oral tablets twice daily Duration: 8 weeks Intervention2: Experimental: 10mg BID: Drug: CP-690,550 oral tablets twice daily Duration: 8 weeks

Eligibility

Inclusion criteria

Inclusion criteria: •Male or female subjects between the ages of 18 and 65 years at screening.

Exclusion criteria

Exclusion criteria: •Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC. •Subjects diagnosed with Crohns disease but without previous exposure to treatment (i.e., treatment-naÃ¯ve). •Subjects receiving the following treatment for Crohns disease: •Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline. •Anti-TNFÎ± therapy within 8 weeks prior to baseline. •Interferon therapy within 8 weeks prior to baseline. •Cyclosporine, mycophenolate, or tacrolimus within 8 weeks prior to baseline. •Intravenous corticosteroids within 2 weeks prior to baseline.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects in clinical remission at week 8 as defined by a Crohns disease activity index (CDAI) score of less than 150 points.Timepoint: Time frame: week 8	—

Secondary

Measure	Time frame
The proportion of subjects achieving clinical response-100 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 100 points from baseline.Timepoint: Time Frame: week 2, 4 and 8;The proportion of subjects achieving clinical response-70 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 70 points from baseline.Timepoint: Time Frame: week 2, 4 and 8;The proportion of subjects achieving either clinical response-100 or clinical remission (CDAI150) at Week 2, 4, and 8.Timepoint: Time Frame: week 2, 4 and 8;The proportions of subjects in clinical remission (CDAI150) at Week 2 and 4.Timepoint: Time Frame: Week 2 and 4.	—

Measure

Time frame

The proportion of subjects achieving clinical response-100 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 100 points from baseline.Timepoint: Time Frame: week 2, 4 and 8;The proportion of subjects achieving clinical response-70 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 70 points from baseline.Timepoint: Time Frame: week 2, 4 and 8;The proportion of subjects achieving either clinical response-100 or clinical remission (CDAI150) at Week 2, 4, and 8.Timepoint: Time Frame: week 2, 4 and 8;The proportions of subjects in clinical remission (CDAI150) at Week 2 and 4.Timepoint: Time Frame: Week 2 and 4.

—

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 ContactSwapnali Raut

Pfizer Limited

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026