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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03281304