Clinical trial NCT03281304: A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
inflammatory bowel disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-09-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Remission Based on Modified Mayo Score at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method
timeFrame: Up to Month 42
measure: 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
timeFrame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
measure: Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
timeFrame: Months 6, 18, 30 and 42
measure: 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
timeFrame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
measure: Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
timeFrame: Months 18, 30 and 42
measure: Change From Baseline in Modified Mayo Score at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
timeFrame: Baseline, Months 18, 30 and 42
measure: Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
timeFrame: Baseline, Months 1, 3 and 6
measure: Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
timeFrame: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
measure: Change From Baseline in Total Mayo Score at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Total Mayo Score at Months 18, 30 and 42
timeFrame: Baseline, Months 18, 30 and 42
measure: Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
timeFrame: Baseline, Months 1, 3 and 6
measure: Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
timeFrame: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
measure: Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
timeFrame: Months 6, 18, 30 and 42
measure: Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
timeFrame: Months 6, 18, 30 and 42
measure: Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
timeFrame: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
measure: 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
timeFrame: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 43 months
measure: Number of Participants With Serious Infections
timeFrame: Baseline up to 43 months
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Baseline up to 27 months
measure: Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation
timeFrame: Baseline up to 43 months
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Baseline up to 43 months
measure: Number of Participants With Clinically Significant Physical Examinations Abnormalities
timeFrame: Baseline up to 43 months
measure: Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
timeFrame: Baseline up to 43 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Surgicare of Mobile
state: Alabama
city: Mobile
country: United States
facility: Alabama Medical Group, P.C.
state: Alabama
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: Bristol
country: United States
facility: Bristol Hospital
state: Connecticut
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute
state: Connecticut
city: Plainville
country: United States
facility: Central Connecticut Endoscopy Center
state: Connecticut
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Macomb
country: United States
facility: Eastside Endoscopy Center
state: Michigan
city: Troy
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Lake Success
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center Research Pharmacy/ Milstein Hospital
state: New York
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Endoscopy Center
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Alpine Medical Group
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Leuven
country: Belgium
facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Strakonice
country: Czechia
facility: Nemocnice Strakonice a.s.
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Pessac
country: France
facility: CHU de Bordeaux Hopital Haut Leveque
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Budapest
country: Hungary
facility: Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft.
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium
city: Catanzaro
country: Italy
facility: Università "Magna Graecia" di Catanzaro
state: CZ
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
state: Hokkaido
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine
state: Tokyo
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
city: Takapuna
country: New Zealand
facility: North Shore Hospital (Waitemata District Health Board)
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Hospital (Canterbury District Health Board)
city: Dunedin
country: New Zealand
facility: Southern District Health Board
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Wroclaw
country: Poland
facility: Lexmedica
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "State Scientific Centre of Coloproctology
city: Novosibirsk
country: Russian Federation
facility: LLC Novosibirskiy Gastrocenter
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy, Clinic for Gastroenterology and Hepatology
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic"
city: Bratislava
country: Slovakia
facility: Medak s.r.o.
city: Nitra
country: Slovakia
facility: KM Management spol. s.r.o.
city: Presov
country: Slovakia
facility: Gastro I., s.r.o., Gastroenterologicka ambulancia
city: Claremont
country: South Africa
facility: Kingsbury Hospital
state: Cape Town
city: Soweto
country: South Africa
facility: Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital
state: Johannesburg, Gauteng
city: Soweto
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: Johannesburg
city: Paarl
country: South Africa
facility: Endocare Research Centre
state: Western CAPE
city: Panorama
country: South Africa
facility: Panorama Mediclinic
state: Western CAPE
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Clinical Hospital" Surgery Departm
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #18
city: Uzhgorod
country: Ukraine
facility: MI Uzhgorod Regional Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
state: Avon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.