PHASE III Study: A study of Oral CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITISâ??. - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/01/003301

Enrollment

654

Registered

2013-01-15

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- Ulcerative Colitis

Interventions

Intervention1: Experimental: 5mg BID: Drug: CP-690,550 oral tablets twice daily Duration: 53 weeks Intervention2: Experimental: 10mg BID: Drug: CP-690,550 oral tablets twice daily Duration: 53 week

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095 2.Subjects who achieved clinical response in Study A3921094 or A3921095 3.Women of childbearing potential must test negative for pregnancy prior to study enrollment 4.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 5.Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Note: There is no upper age limit mentioned in the protocol

Exclusion criteria

Exclusion criteria: 1. Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095 2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns disease 3. Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects in remission at Week 52Timepoint: Time frame: week 52	—

Secondary

Measure	Time frame
1. The proportion of subjects with mucosal healing at Week 52 Timepoint: Time Frame: 52 Week;The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096Timepoint: Time Frame: 24 Week & 52 Week	—

Countries

Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States of America

Contacts

Public ContactSwapnali Raut

Representing Pfizer Limited

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

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