Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 27 September 2021
• Main ID: NCT01470612
• Date of registration: 21/10/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis OCTAVE
• Scientific title: A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
• Date of first enrolment: October 1, 2012
• Target sample size: 944
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01470612
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Czechia, Denmark, Estonia, France, Germany, Hungary, India, 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 completed induction studies A3921094 or A3921095 and were classified as
not meeting clinical response criteria; OR

- Subjects who completed maintenance study A3921096 or who discontinued treatment early
in Study A3921096 due to treatment failure.

Exclusion Criteria:

- Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.

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

- Subjects who have had surgery for ulcerative colitis or in the opinion of the
investigator, are likely to require surgery for ulcerative colitis 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

Primary Outcome(s)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)]

Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline [Time Frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)]

Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) [Time Frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)]

Number of Participants With Vital Sign Abnormalities [Time Frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)]

Number of Participants With Laboratory Test Abnormalities [Time Frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)]

Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events [Time Frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)]

Number of Participants With Electrocardiogram (ECG) Abnormalities [Time Frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)]

Secondary Outcome(s)

Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases [Time Frame: Months 2, 12, 24 and 36]

Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) [Time Frame: Months 2, 12, 24 and 36]

Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) [Time Frame: Months 2, 12, 24 and 36]

Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) [Time Frame: Months 2, 12, 24 and 36]

Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases [Time Frame: Months 2, 12, 24 and 36]

Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases [Time Frame: Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84]

Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) [Time Frame: Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84]

Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases [Time Frame: Months 2, 12, 24 and 36]

Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) [Time Frame: Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84]

Secondary ID(s)

2011-004581-14

A3921139

OCTAVEOPEN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/09/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01470612