PHASE 2b Study To Evaluate SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN PATIENTS WITH MODERATE TO SEVERE CROHNâ??S DISEASE

A PHASE 2b â??A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHNâ??S DISEASE - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003272

Enrollment

275

Registered

2012-12-31

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- Crohns disease.

Interventions

Intervention1: Experimental: 5mg BID: Drug: CP-690,550 oral tablets twice daily Duration 30 weeks Intervention2: Experimental: 10mg BID: Drug: CP-690,550 oral tablets twice daily Duration 30 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083. 2. Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI 3. Women of childbearing potential must test negative for pregnancy prior to study enrolment.

Exclusion criteria

Exclusion criteria: 1. Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study. 2. Subjects likely to require any type of surgery during the study period. 3. Fecal culture/toxin assay indicating presence of pathogenic infection.

Design outcomes

Primary

Measure	Time frame
â?¢The proportion of subjects maintaining clinical response-100, as defined by a decrease in CDAI score at least 100 points from A3921083 baseline, or being in clinical remission, as defined by a CDAI score less than 150, at Week 26.Timepoint: At 26 week	—

Secondary

Measure	Time frame
The proportion of subjects achieving a steroid-free clinical remission at Week 26 of the maintenance phase among subjects on steroids at baseline.Timepoint: At 26 week;The proportion of subjects achieving sustained clinical response in the maintenance phase. Sustained clinical response is defined as having at least a clinical response-100 at both Weeks 20 and 26 from the A3921083 Baseline.Timepoint: At 20 and 26 weeks.;The proportion of subjects in clinical remission at Weeks 4, 8, 12, 20 and 26.Timepoint: At 4, 8, 12, 20 and 26 weeks.;The proportion of subjects in clinical remission at Weeks 4, 8, 12, 20, and 26 among subjects in clinical remission at baseline of maintenance study.Timepoint: At 4, 8, 12, 20, and 26 Weeks;The proportion of subjects in sustained clinical remission in the maintenance phase. Sustained clinical remission is defined as being in clinical remission at both Weeks 20 and 26.Timepoint: At 20 and 26 Weeks.;The proportion of subjects maintaining at least a clinical response-100 at Weeks 4, 8, 12, 20 and 26.Timepoint: at 4, 8, 12, 20 and 26 Weeks.;The proportion of subjects maintaining clinical response-100 or being in clinical remission at Weeks 4, 8, 12, 20 and 26 from the A3921083 Baseline.Timepoint: At 4, 8,12,20 and 26 weeks	—

Measure

Time frame

The proportion of subjects achieving a steroid-free clinical remission at Week 26 of the maintenance phase among subjects on steroids at baseline.Timepoint: At 26 week;The proportion of subjects achieving sustained clinical response in the maintenance phase. Sustained clinical response is defined as having at least a clinical response-100 at both Weeks 20 and 26 from the A3921083 Baseline.Timepoint: At 20 and 26 weeks.;The proportion of subjects in clinical remission at Weeks 4, 8, 12, 20 and 26.Timepoint: At 4, 8, 12, 20 and 26 weeks.;The proportion of subjects in clinical remission at Weeks 4, 8, 12, 20, and 26 among subjects in clinical remission at baseline of maintenance study.Timepoint: At 4, 8, 12, 20, and 26 Weeks;The proportion of subjects in sustained clinical remission in the maintenance phase. Sustained clinical remission is defined as being in clinical remission at both Weeks 20 and 26.Timepoint: At 20 and 26 Weeks.;The proportion of subjects maintaining at least a clinical response-100 at Weeks 4, 8, 12, 20 and 26.Timepoint: at 4, 8, 12, 20 and 26 Weeks.;The proportion of subjects maintaining clinical response-100 or being in clinical remission at Weeks 4, 8, 12, 20 and 26 from the A3921083 Baseline.Timepoint: At 4, 8,12,20 and 26 weeks

—

Countries

Australia, Austria, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Japan, Netherlands, Norway, 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