A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

• Register: ClinicalTrials.gov
• Last refreshed on: 3 May 2021
• Main ID: NCT03281304
• Date of registration: 11/09/2017
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
• Scientific title: A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION
• Date of first enrolment: November 16, 2017
• Target sample size: 141
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03281304
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2
years consecutively.

- In stable remission on CP-690,550 10 mg BID

- Agree to use highly effective contraception

- Negative pregnancy test

- Comply with visits, treatments, lab tests, diary and other study procedures

- Signed and dated informed consent document.

Exclusion Criteria:

- Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study
A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.

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

- Likely to require surgery for ulcerative colitis during study

- Expected to receive any prohibited medication

- Expected to receive live or attenuated virus vaccination during study

- Women who are pregnant or breastfeeding or planning to become pregnant during the
study

- Evidence of colonic malignancy or any dysplasia

- Acute or chronic medical or psychiatric condition that may increase risk of
participation

- Investigator site staff member

- Subjects likely to be uncooperative or unable to comply with study procedures

- Participation in other studies involving investigational drugs during study

- Subjects with any of the following risk factors for pulmonary embolism at baseline as
defined by EMA's PRAC:

- has heart failure;

- has inherited coagulation disorders;

- has had venous thromboembolism, either deep venous thrombosis or pulmonary
embolism;

- is taking combined hormonal contraceptives or hormone replacement therapy;

- has malignancy (association is strongest with cancers other than non-melanoma
skin cancers);

- is undergoing major surgery



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 10 mg

Drug: CP-690,500 5 mg

Primary Outcome(s)

Number of Participants With Remission Based on Modified Mayo Score at Month 6 [Time Frame: Month 6]

Secondary Outcome(s)

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3 and 6 [Time Frame: Baseline, Months 1, 3 and 6]

Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6 [Time Frame: Baseline, Months 1, 3 and 6]

Kaplan-Meier Estimated Rate at Month 6 for Time to Loss of Remission Based on Modified Mayo Score [Time Frame: Month 6]

Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3 and 6 [Time Frame: Months 1, 3 and 6]

Number of Participants With Serious Infections [Time Frame: Baseline up to 27 months]

Change From Baseline in Total Mayo Score at Month 6 [Time Frame: Baseline, Month 6]

Number of Participants With Clinical Laboratory Abnormalities [Time Frame: Baseline up to 27 months]

Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee [Time Frame: Baseline up to 27 months]

Number of Participants With Mucosal Healing at Month 6 [Time Frame: Month 6]

Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3 and 6 [Time Frame: Months 1, 3 and 6]

Change From Baseline in Fecal Calprotectin at Months 1, 3 and 6 [Time Frame: Baseline, Months 1, 3 and 6]

Change From Baseline in Partial Mayo Score at Months 1, 3 and 6 [Time Frame: Baseline, Months 1, 3 and 6]

Number of Participants With Clinically Significant Physical Examinations Abnormalities [Time Frame: Baseline up to 27 months]

Number of Participants With Clinical Response Based on Mayo Score at Month 6 [Time Frame: Month 6]

Change From Baseline in Modified Mayo Score at Month 6 [Time Frame: Baseline, Month 6]

Number of Participants With Remission Based on Total Mayo Score at Month 6 [Time Frame: Month 6]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 27 months]

Number of Participants With Vital Sign Abnormalities [Time Frame: Baseline up to 27 months]

Secondary ID(s)

A3921288

2017-002274-39

RIVETING STUDY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/04/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03281304