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

NCT03281304 | Terminated Phase 4 Results DMC FDA Drug

• 3 other identifiers: A3921288RIVETING STUDY2017-002274-39
• Study Type: interventional
• Target: 140
• Locations: 20 countries
• Sites: 80

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.

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Remission Based on Modified Mayo Score at Month 6

  Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.

  Month 6

Secondary Outcomes (24)

• Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method

  Up to Month 42

• 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

  Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

• Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42

  Months 6, 18, 30 and 42

• 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

  Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

• Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42

  Months 18, 30 and 42

Study Arms (2)

CP-690,550 5 mg

EXPERIMENTAL

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

Drug: CP-690,500 5 mg

CP-690,550 10 mg

EXPERIMENTAL

CP-690,550 10 mg BID

Drug: CP-690,550 10 mg

Interventions

CP-690,500 5 mg DRUG

CP-690,550 5 mg tablet BID

CP-690,550 5 mg

CP-690,550 10 mg DRUG

CP-690,550 10 mg tablet BID

CP-690,550 10 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Pfizer: lead

Study Sites (80)

Surgicare of Mobile

Mobile, Alabama, 36606, United States

Location

Alabama Medical Group, P.C.

Mobile, Alabama, 36608, United States

Location

Clinical Applications Laboratories, Inc.

San Diego, California, 92103, United States

Location

Bristol Hospital

Bristol, Connecticut, 06010, United States

Location

Connecticut Clinical Research Institute

Bristol, Connecticut, 06010, United States

Location

Central Connecticut Endoscopy Center

Plainville, Connecticut, 06062, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

Florida Medical Clinic, P.A.

Zephyrhills, Florida, 33542, United States

Location

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, 66606, United States

Location

Chevy Chase Endoscopy Center

Chevy Chase, Maryland, 20815, United States

Location

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Eastside Endoscopy Center

Macomb, Michigan, 48044, United States

Location

Clinical Research Institute of Michigan, LLC

Troy, Michigan, 48098, United States

Location

NYU Langone Long Island Clinical Research Associates

Lake Success, New York, 11042, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Columbia University Medical Center Research Pharmacy/ Milstein Hospital

New York, New York, 10032, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School

Houston, Texas, 77030, United States

Location

Christus Trinity Mother Frances Endoscopy Center

Tyler, Texas, 75701, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

Alpine Medical Group

Salt Lake City, Utah, 84102, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

Leuven, 3000, Belgium

Location

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Nemocnice Strakonice a.s.

Strakonice, 386 01, Czechia

Location

CHU Hotel Dieu

Nantes, 44093, France

Location

CHU de Bordeaux Hopital Haut Leveque

Pessac, 33600, France

Location

Universitaetsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak

Budapest, 1125, Hungary

Location

Pannonia Maganorvosi Centrum Kft.

Budapest, 1136, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium

Gyula, 5700, Hungary

Location

Università "Magna Graecia" di Catanzaro

Catanzaro, CZ, 88100, Italy

Location

Aichi Medical University Hospital

Nagakute, Aichi-ken, 480-1195, Japan

Location

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

Sapporo, Hokkaido, 060-0033, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-shi, Osaka, 569-8686, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

Location

Tokyo Medical And Dental University Hospital, Faculty of Medicine

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Tokai University Hachioji Hospital

Hachiōji, Tokyo, 192-0032, Japan

Location

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642, Japan

Location

Showa University Hospital

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Toho University Sakura Medical Center

Chiba, 285-8741, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Academic Medical Centre

Amsterdam, 1105 AZ, Netherlands

Location

North Shore Hospital (Waitemata District Health Board)

Takapuna, Auckland, 0620, New Zealand

Location

Christchurch Hospital (Canterbury District Health Board)

Christchurch, 8011, New Zealand

Location

Southern District Health Board

Dunedin, 9016, New Zealand

Location

Endoskopia Sp. z o.o.

Sopot, 81-756, Poland

Location

Lexmedica

Wroclaw, 53-114, Poland

Location

Federal State Budgetary Institution "State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

LLC Novosibirskiy Gastrocenter

Novosibirsk, 630007, Russia

Location

Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology

Novosibirsk, 630117, Russia

Location

Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

Belgrade, 11000, Serbia

Location

Clinical Hospital Centre Zvezdara

Belgrade, 11000, Serbia

Location

Military Medical Academy, Clinic for Gastroenterology and Hepatology

Belgrade, 11000, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

General Hospital "Djordje Joanovic"

Zrenjanin, 23000, Serbia

Location

Medak s.r.o.

Bratislava, 851 01, Slovakia

Location

KM Management spol. s.r.o.

Nitra, 949 01, Slovakia

Location

Gastro I., s.r.o., Gastroenterologicka ambulancia

Prešov, 080 01, Slovakia

Location

Kingsbury Hospital

Claremont, CAPE TOWN, 7708, South Africa

Location

Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital

Soweto, Johannesburg, Gauteng, 2013, South Africa

Location

Chris Hani Baragwanath Academic Hospital

Soweto, Johannesburg, 2013, South Africa

Location

Endocare Research Centre

Paarl, Western Cape, 7646, South Africa

Location

Panorama Mediclinic

Panorama, Western Cape, 7500, South Africa

Location

Hanyang University Guri Hospital

Gyeonggi-do, 11923, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Clinical Hospital" Surgery Departm

Chernivtsi, 58001, Ukraine

Location

Kyiv Municipal Clinical Hospital #18

Kyiv, 01030, Ukraine

Location

MI Uzhgorod Regional Hospital

Uzhhorod, 88009, Ukraine

Location

Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2

Vinnytsia, 21005, Ukraine

Location

University Hospitals Bristol NHS Foundation Trust

Bristol, AVON, BS2 8HW, United Kingdom

Location

Related Publications (5)

• Torres J, D'Haens GR, Regueiro M, Santana G, Panes J, Vermeire S, Gardiner S, Kulisek N, Modesto I, Su C, Lawendy N, Mundayat R, Paulissen J, Dubinsky MC. Potential predictors of efficacy outcomes following tofacitinib dose reduction in patients with ulcerative colitis in stable remission: a post hoc analysis of outcomes from the RIVETING study. Therap Adv Gastroenterol. 2025 Feb 27;18:17562848251318849. doi: 10.1177/17562848251318849. eCollection 2025.

  PMID: 40028509 DERIVED

• Panes J, D'Haens GR, Sands BE, Ng SC, Lawendy N, Kulisek N, Guo X, Wu J, Vranic I, Panaccione R, Vermeire S. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure. United European Gastroenterol J. 2024 Jul;12(6):793-801. doi: 10.1002/ueg2.12584. Epub 2024 May 22.

  PMID: 38778549 DERIVED

• Rubin DT, Torres J, Regueiro M, Reinisch W, Prideaux L, Kotze PG, Tan FH, Gardiner S, Mundayat R, Cadatal MJ, Ng SC. Association Between Smoking Status and the Efficacy and Safety of Tofacitinib in Patients with Ulcerative Colitis. Crohns Colitis 360. 2024 Jan 20;6(1):otae004. doi: 10.1093/crocol/otae004. eCollection 2024 Jan.

  PMID: 38425446 DERIVED

• Sandborn WJ, D'Haens GR, Sands BE, Panaccione R, Ng SC, Lawendy N, Kulisek N, Modesto I, Guo X, Mundayat R, Su C, Vranic I, Panes J. Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme. J Crohns Colitis. 2023 Apr 3;17(3):338-351. doi: 10.1093/ecco-jcc/jjac141.

  PMID: 36124702 DERIVED

• 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.

  PMID: 35648151 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: November 16, 2017
• Primary Completion: February 14, 2020
• Study Completion: March 18, 2022
• Last Updated: March 21, 2023
• Results First Posted: April 15, 2021

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (24); RU (3); PL (2); CA (2); IT (1); JP (14); CZ (1); KR (3); NL (1); ES (1); HU (3); NZ (3); DE (1); SE (5); UA (4); SL (3); FR (2); ZA (5); GB (1); BE (1)