A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01458574
• Date of registration: 21/10/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis OCTAVE
• Scientific title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
• Date of first enrolment: July 20, 2012
• Target sample size: 593
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01458574
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who met study entry criteria and completed 8-week induction treatment from
Study A3921094 or A3921095

- Subjects who achieved clinical response in Study A3921094 or A3921095

- Women of childbearing potential must test negative for pregnancy prior to study
enrollment

- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures

- 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.

Exclusion Criteria:

- Subjects who had major protocol violation (as determined by the Sponsor) in Study
A3921094 or A3921095

- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: CP-690,550

Drug: Placebo

Drug: CP690,550

Primary Outcome(s)

Percentage of Participants In Remission at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline [Time Frame: Week 24, 52]

Percentage of Participants With Clinical Response at Week 24 and 52 [Time Frame: Week 24, 52]

Change From Baseline in Total Mayo Score at Week 24 and 52 [Time Frame: Baseline, Week 24, 52]

Percentage of Participants in Deep Remission at Week 24 and 52 [Time Frame: Week 24, 52]

Percentage of Participants in Endoscopic Remission at Week 24 and 52 [Time Frame: Week 24, 52]

Percentage of Participants in Remission, Among Participants With Remission at Baseline [Time Frame: Week 24, 52]

Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline [Time Frame: Week 24, 52]

Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline [Time Frame: Week 24, 52]

Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline [Time Frame: Week 24, 52]

Percentage of Participants in Sustained Clinical Remission [Time Frame: Week 24, 52]

Percentage of Participants in Sustained Remission [Time Frame: Week 24, 52]

Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline [Time Frame: Week 24, 52]

Percentage of Participants in Clinical Remission at Week 24 and 52 [Time Frame: Week 24, 52]

Percentage of Participants in Remission at Week 24 [Time Frame: Week 24]

Percentage of Participants in Sustained Deep Remission [Time Frame: Week 24, 52]

Percentage of Participants in Sustained Symptomatic Remission [Time Frame: Week 24, 52]

Percentage of Participants With Mucosal Healing at Week 24 [Time Frame: Week 24]

Total Mayo Score at Baseline, Week 24 and 52 [Time Frame: Baseline, Week 24, 52]

Percentage of Participants in Sustained Endoscopic Remission [Time Frame: Week 24, 52]

Percentage of Participants With Sustained Clinical Response [Time Frame: Week 24, 52]

Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline [Time Frame: Week 24, 52]

Percentage of Participants in Symptomatic Remission at Week 24 and 52 [Time Frame: Week 24, 52]

Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline [Time Frame: Week 24, 52]

Percentage of Participants With Mucosal Healing at Week 52 [Time Frame: Week 52]

Percentage of Participants With Sustained Mucosal Healing [Time Frame: Week 24, 52]

Secondary ID(s)

OCTAVESUSTAIN

A3921096

2011-004580-79

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01458574