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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03281304




Registration number
NCT03281304
Ethics application status
Date submitted
11/09/2017
Date registered
13/09/2017
Date last updated
21/03/2023

Titles & IDs
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
Secondary ID [1] 0 0
RIVETING STUDY
Secondary ID [2] 0 0
A3921288
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-690,500 5 mg
Treatment: Drugs - CP-690,550 10 mg

Experimental: CP-690,550 5 mg - CP-690,550 5 mg tablet by mouth twice a day (BID)

Experimental: CP-690,550 10 mg - CP-690,550 10 mg BID


Treatment: Drugs: CP-690,500 5 mg
CP-690,550 5 mg tablet BID

Treatment: Drugs: CP-690,550 10 mg
CP-690,550 10 mg tablet BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Remission Based on Modified Mayo Score at Month 6
Timepoint [1] 0 0
Month 6
Secondary outcome [1] 0 0
Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method
Timepoint [1] 0 0
Up to Month 42
Secondary outcome [2] 0 0
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Timepoint [2] 0 0
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Secondary outcome [3] 0 0
Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
Timepoint [3] 0 0
Months 6, 18, 30 and 42
Secondary outcome [4] 0 0
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Timepoint [4] 0 0
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Secondary outcome [5] 0 0
Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
Timepoint [5] 0 0
Months 18, 30 and 42
Secondary outcome [6] 0 0
Change From Baseline in Modified Mayo Score at Month 6
Timepoint [6] 0 0
Baseline, Month 6
Secondary outcome [7] 0 0
Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
Timepoint [7] 0 0
Baseline, Months 18, 30 and 42
Secondary outcome [8] 0 0
Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
Timepoint [8] 0 0
Baseline, Months 1, 3 and 6
Secondary outcome [9] 0 0
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Timepoint [9] 0 0
Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Secondary outcome [10] 0 0
Change From Baseline in Total Mayo Score at Month 6
Timepoint [10] 0 0
Baseline, Month 6
Secondary outcome [11] 0 0
Change From Baseline in Total Mayo Score at Months 18, 30 and 42
Timepoint [11] 0 0
Baseline, Months 18, 30 and 42
Secondary outcome [12] 0 0
Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
Timepoint [12] 0 0
Baseline, Months 1, 3 and 6
Secondary outcome [13] 0 0
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Timepoint [13] 0 0
Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Secondary outcome [14] 0 0
Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
Timepoint [14] 0 0
Months 6, 18, 30 and 42
Secondary outcome [15] 0 0
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Timepoint [15] 0 0
Months 6, 18, 30 and 42
Secondary outcome [16] 0 0
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Timepoint [16] 0 0
Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Secondary outcome [17] 0 0
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Timepoint [17] 0 0
Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Secondary outcome [18] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [18] 0 0
Baseline up to 43 months
Secondary outcome [19] 0 0
Number of Participants With Serious Infections
Timepoint [19] 0 0
Baseline up to 43 months
Secondary outcome [20] 0 0
Number of Participants With Clinical Laboratory Abnormalities
Timepoint [20] 0 0
Baseline up to 27 months
Secondary outcome [21] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation
Timepoint [21] 0 0
Baseline up to 43 months
Secondary outcome [22] 0 0
Number of Participants With Vital Sign Abnormalities
Timepoint [22] 0 0
Baseline up to 43 months
Secondary outcome [23] 0 0
Number of Participants With Clinically Significant Physical Examinations Abnormalities
Timepoint [23] 0 0
Baseline up to 43 months
Secondary outcome [24] 0 0
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
Timepoint [24] 0 0
Baseline up to 43 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/03/2022
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Saskatchewan
Country [15] 0 0
Czechia
State/province [15] 0 0
Strakonice
Country [16] 0 0
France
State/province [16] 0 0
Nantes
Country [17] 0 0
France
State/province [17] 0 0
Pessac
Country [18] 0 0
Germany
State/province [18] 0 0
Kiel
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
Hungary
State/province [20] 0 0
Gyula
Country [21] 0 0
Italy
State/province [21] 0 0
CZ
Country [22] 0 0
Japan
State/province [22] 0 0
Aichi
Country [23] 0 0
Japan
State/province [23] 0 0
Fukuoka
Country [24] 0 0
Japan
State/province [24] 0 0
Hokkaido
Country [25] 0 0
Japan
State/province [25] 0 0
Osaka
Country [26] 0 0
Japan
State/province [26] 0 0
Shiga
Country [27] 0 0
Japan
State/province [27] 0 0
Tokyo
Country [28] 0 0
Japan
State/province [28] 0 0
Chiba
Country [29] 0 0
Japan
State/province [29] 0 0
Hiroshima
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Gyeonggi-do
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Netherlands
State/province [32] 0 0
Amsterdam
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
New Zealand
State/province [35] 0 0
Dunedin
Country [36] 0 0
Poland
State/province [36] 0 0
Sopot
Country [37] 0 0
Poland
State/province [37] 0 0
Wroclaw
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Novosibirsk
Country [40] 0 0
Serbia
State/province [40] 0 0
Belgrade
Country [41] 0 0
Serbia
State/province [41] 0 0
Kragujevac
Country [42] 0 0
Serbia
State/province [42] 0 0
Zrenjanin
Country [43] 0 0
Slovakia
State/province [43] 0 0
Bratislava
Country [44] 0 0
Slovakia
State/province [44] 0 0
Nitra
Country [45] 0 0
Slovakia
State/province [45] 0 0
Presov
Country [46] 0 0
South Africa
State/province [46] 0 0
Cape Town
Country [47] 0 0
South Africa
State/province [47] 0 0
Johannesburg, Gauteng
Country [48] 0 0
South Africa
State/province [48] 0 0
Johannesburg
Country [49] 0 0
South Africa
State/province [49] 0 0
Western CAPE
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Ukraine
State/province [51] 0 0
Chernivtsi
Country [52] 0 0
Ukraine
State/province [52] 0 0
Kyiv
Country [53] 0 0
Ukraine
State/province [53] 0 0
Uzhgorod
Country [54] 0 0
Ukraine
State/province [54] 0 0
Vinnytsia
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Avon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.
Trial website
https://clinicaltrials.gov/study/NCT03281304
Trial related presentations / publications
Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03281304