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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03281304

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 4

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Pfizer

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries 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

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Wasatch Clinical Research, LLC, Salt Lake City, Utah

Status

Not yet recruiting

Address

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107

Salt Lake Regional Medical Center, Salt Lake City, Utah

Status

Not yet recruiting

Address

Salt Lake Regional Medical Center

Salt Lake City, Utah, 84102

Alpine Medical Group, Salt Lake City, Utah

Status

Not yet recruiting

Address

Alpine Medical Group

Salt Lake City, Utah, 84102

Tyler Research Institute, LLC, Tyler, Texas

Status

Recruiting

Address

Tyler Research Institute, LLC

Tyler, Texas, 75701

Tyler, Texas

Status

Recruiting

Address

Christus Trinity Mother Frances Endoscopy Center

Tyler, Texas, 75701

UT Health Science Center at Houston, Houston, Texas

Status

Recruiting

Address

UT Health Science Center at Houston

Houston, Texas, 77030

Memorial Hermann Hospital, Houston, Texas

Status

Recruiting

Address

Memorial Hermann Hospital

Houston, Texas, 77030

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

CUMC - Research Pharmacy, New York, New York

Status

Recruiting

Address

CUMC - Research Pharmacy

New York, New York, 10032

New York, New York

Status

Recruiting

Address

Columbia University Medical Center, Herbert Irving Pavillion

New York, New York, 10032

CUMC - The Office of Simon Lichtiger, New York, New York

Status

Recruiting

Address

CUMC - The Office of Simon Lichtiger

New York, New York, 10028

CUMC - Columbia Doctors, New York, New York

Status

Recruiting

Address

CUMC - Columbia Doctors

New York, New York, 10019

Great Neck, New York

Status

Recruiting

Address

NYU Langone Nassau Gastroenterology Associates

Great Neck, New York, 11021

Great Neck, New York

Status

Recruiting

Address

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, 11021

Surgical Centers of Michigan, Troy, Michigan

Status

Recruiting

Address

Surgical Centers of Michigan

Troy, Michigan, 48098

Center for Digestive Health, Troy, Michigan

Status

Recruiting

Address

Center for Digestive Health

Troy, Michigan, 48098

Eastside Endoscopy Center, Macomb, Michigan

Status

Recruiting

Address

Eastside Endoscopy Center

Macomb, Michigan, 48044

Chesterfield, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047

Chevy Chase, Maryland

Status

Recruiting

Address

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

Chevy Chase, Maryland, 20815

Chevy Chase Endoscopy Center, Chevy Chase, Maryland

Status

Recruiting

Address

Chevy Chase Endoscopy Center

Chevy Chase, Maryland, 20815

Topeka, Kansas

Status

Recruiting

Address

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, 66606

Florida Medical Clinic, P.A., Zephyrhills, Florida

Status

Recruiting

Address

Florida Medical Clinic, P.A.

Zephyrhills, Florida, 33542

Advanced Medical Research Center, Port Orange, Florida

Status

Recruiting

Address

Advanced Medical Research Center

Port Orange, Florida, 32127

Central Connecticut Endoscopy Center, Plainville, Connecticut

Status

Recruiting

Address

Central Connecticut Endoscopy Center

Plainville, Connecticut, 06062

Connecticut Clinical Research Foundation, Bristol, Connecticut

Status

Recruiting

Address

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010

Bristol Hospital, Bristol, Connecticut

Status

Recruiting

Address

Bristol Hospital

Bristol, Connecticut, 06010

San Diego, California

Status

Recruiting

Address

San Diego Endoscopy Center (Endoscopies Only)

San Diego, California, 92103

Clinical Applications Laboratories, Inc., San Diego, California

Status

Recruiting

Address

Clinical Applications Laboratories, Inc.

San Diego, California, 92103

Alabama Medical Group, P.C., Mobile, Alabama

Status

Recruiting

Address

Alabama Medical Group, P.C.

Mobile, Alabama, 36608

Surgicare of Mobile, Mobile, Alabama

Status

Recruiting

Address

Surgicare of Mobile

Mobile, Alabama, 36606

International Sites

Bristol, Avon, United Kingdom

Status

Recruiting

Address

University Hospitals Bristol NHS Foundation Trust

Bristol, Avon, BS2 8HW

Municipal Institution" City Hospital #7", Zaporizhzhia, Ukraine

Status

Not yet recruiting

Address

Municipal Institution" City Hospital #7"

Zaporizhzhia, , 69118

Vinnytsia, Ukraine

Status

Recruiting

Address

Vinnytsia Regional Clinical Hospital for War Veterans,

Vinnytsia, , 21005

MI Uzhgorod Regional Hospital, Uzhgorod, Ukraine

Status

Recruiting

Address

MI Uzhgorod Regional Hospital

Uzhgorod, , 88009

Kyiv Municipal Clinical Hospital #18, Kyiv, Ukraine

Status

Recruiting

Address

Kyiv Municipal Clinical Hospital #18

Kyiv, , 01030

Kharkiv, Ukraine

Status

Not yet recruiting

Address

Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 n.a. prof. O.O. Shalimov

Kharkiv, , 61037

Chernivtsi, Ukraine

Status

Recruiting

Address

RMI "Chernivtsi Regional Clinical Hospital", Surg. Dep.

Chernivtsi, , 58001

Hospital Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona

Barcelona, , 08036

Panorama Mediclinic, Panorama, Western CAPE, South Africa

Status

Recruiting

Address

Panorama Mediclinic

Panorama, Western CAPE, 7500

Endocare Research Centre, Paarl, Western CAPE, South Africa

Status

Recruiting

Address

Endocare Research Centre

Paarl, Western CAPE, 7646

Chris Hani Baragwanath Academic Hospital, Soweto, Johannesburg, South Africa

Status

Recruiting

Address

Chris Hani Baragwanath Academic Hospital

Soweto, Johannesburg, 2013

Soweto, Johannesburg, Gauteng, South Africa

Status

Recruiting

Address

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

Soweto, Johannesburg, Gauteng, 2013

Kingsbury Hospital, Claremont, Cape Town, South Africa

Status

Recruiting

Address

Kingsbury Hospital

Claremont, Cape Town, 7708

Presov, Slovakia

Status

Recruiting

Address

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

Presov, , 080 01

KM Management spol. s.r.o., Nitra, Slovakia

Status

Recruiting

Address

KM Management spol. s.r.o.

Nitra, , 949 01

Medak s.r.o., Bratislava, Slovakia

Status

Recruiting

Address

Medak s.r.o.

Bratislava, , 851 01

General Hospital "Djordje Joanovic", Zrenjanin, Serbia

Status

Recruiting

Address

General Hospital "Djordje Joanovic"

Zrenjanin, , 23000

Clinical Centre of Kragujevac, Kragujevac, Serbia

Status

Recruiting

Address

Clinical Centre of Kragujevac

Kragujevac, , 34000

Belgrade, Serbia

Status

Recruiting

Address

Military Medical Academy, Clinic for Gastroenterology and Hepatology

Belgrade, , 11000

Clinical Hospital Centre Zvezdara, Belgrade, Serbia

Status

Recruiting

Address

Clinical Hospital Centre Zvezdara

Belgrade, , 11000

Belgrade, Serbia

Status

Recruiting

Address

Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

Belgrade, , 11000

Novosibirsk, Russian Federation

Status

Recruiting

Address

Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology

Novosibirsk, , 630117

Moscow, Russian Federation

Status

Recruiting

Address

Federal State Budgetary Institution "State Scientific Centre of Coloproctology

Moscow, , 123423

Lexmedica, Wroclaw, Poland

Status

Recruiting

Address

Lexmedica

Wroclaw, , 53-114

Endoskopia Sp. z o.o., Sopot, Poland

Status

Recruiting

Address

Endoskopia Sp. z o.o.

Sopot, , 81-756

Southern District Health Board, Dunedin, New Zealand

Status

Active, not recruiting

Address

Southern District Health Board

Dunedin, , 9016

Southern Endoscopy Centre, Christchurch, New Zealand

Status

Active, not recruiting

Address

Southern Endoscopy Centre

Christchurch, , 8013

Christchurch, New Zealand

Status

Active, not recruiting

Address

Christchurch Hospital (Canterbury District Health Board)

Christchurch, , 8011

Auckland, New Zealand

Status

Recruiting

Address

North Shore Hospital (Waitemata District Health Board)

Auckland, , 0620

Mercy Hospital, Manaaki by Mercy, Dunedin, Otago, New Zealand

Status

Active, not recruiting

Address

Mercy Hospital, Manaaki by Mercy

Dunedin, Otago, 9054

Academic Medical Centre, Amsterdam, Netherlands

Status

Recruiting

Address

Academic Medical Centre

Amsterdam, , 1105 AZ

Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Severance Hospital, Yonsei University Health System

Seoul, , 03722

Kyung Hee University Hospital, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Kyung Hee University Hospital

Seoul, , 02447

Hanyang University Guri Hospital, Gyeonggi-do, Korea, Republic of

Status

Active, not recruiting

Address

Hanyang University Guri Hospital

Gyeonggi-do, , 11923

Keio University Hospital, Tokyo, Japan

Status

Active, not recruiting

Address

Keio University Hospital

Tokyo, , 160-8582

Osaka City University Hospital, Osaka, Japan

Status

Active, not recruiting

Address

Osaka City University Hospital

Osaka, , 545-8586

Hiroshima University Hospital, Hiroshima, Japan

Status

Active, not recruiting

Address

Hiroshima University Hospital

Hiroshima, , 734-8551

Toho University Sakura Medical Center, Chiba, Japan

Status

Active, not recruiting

Address

Toho University Sakura Medical Center

Chiba, , 285-8741

Showa University Hospital, Shinagawa-ku, Tokyo, Japan

Status

Active, not recruiting

Address

Showa University Hospital

Shinagawa-ku, Tokyo, 142-8666

Minato-ku, Tokyo, Japan

Status

Active, not recruiting

Address

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642

Tokai University Hachioji Hospital, Hachioji, Tokyo, Japan

Status

Active, not recruiting

Address

Tokai University Hachioji Hospital

Hachioji, Tokyo, 192-0032

Bunkyo-ku, Tokyo, Japan

Status

Active, not recruiting

Address

Tokyo Medical And Dental University Hospital, Faculty of Medicine

Bunkyo-ku, Tokyo, 113-8519

Otsu, Shiga, Japan

Status

Active, not recruiting

Address

Shiga University of Medical Science Hospital

Otsu, Shiga, 520-2192

Osaka Medical College Hospital, Takatsuki-shi, Osaka, Japan

Status

Active, not recruiting

Address

Osaka Medical College Hospital

Takatsuki-shi, Osaka, 569-8686

Sapporo, Hokkaido, Japan

Status

Active, not recruiting

Address

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

Sapporo, Hokkaido, 060-0033

Kurume University Hospital, Kurume, Fukuoka, Japan

Status

Active, not recruiting

Address

Kurume University Hospital

Kurume, Fukuoka, 830-0011

Fukuoka University Chikushi Hospital, Chikushino, Fukuoka, Japan

Status

Active, not recruiting

Address

Fukuoka University Chikushi Hospital

Chikushino, Fukuoka, 818-8502

Aichi Medical University Hospital, Nagakute, Aichi, Japan

Status

Active, not recruiting

Address

Aichi Medical University Hospital

Nagakute, Aichi, 480-1195

Rozzano, Milano, Italy

Status

Not yet recruiting

Address

Istituto Clinico Humanitas - Istituti di Ricovero E Cura A Carattere Scientifico (IRCSS)

Rozzano, Milano, 20089

Università "Magna Graecia" di Catanzaro, Catanzaro, CZ, Italy

Status

Recruiting

Address

Università "Magna Graecia" di Catanzaro

Catanzaro, CZ, 88100

Szent Margit Korhaz, Budapest, Hungary

Status

Not yet recruiting

Address

Szent Margit Korhaz

Budapest, , H-1032

Pannonia Maganorvosi Centrum Kft., Budapest, Hungary

Status

Recruiting

Address

Pannonia Maganorvosi Centrum Kft.

Budapest, , 1136

Budapest, Hungary

Status

Recruiting

Address

Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak

Budapest, , 1125

Gyula, Bekes, Hungary

Status

Recruiting

Address

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium

Gyula, Bekes, 5700

Universitaetsklinikum Schleswig-Holstein, Kiel, Germany

Status

Recruiting

Address

Universitaetsklinikum Schleswig-Holstein

Kiel, , 24105

CHU de Bordeaux Hopital Haut Leveque, Pessac, France

Status

Active, not recruiting

Address

CHU de Bordeaux Hopital Haut Leveque

Pessac, , 33600

Nantes, France

Status

Recruiting

Address

CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie

Nantes, , 44093

Strakonice, Czechia

Status

Recruiting

Address

Ustavni lekarna Nemocnice Strakonice, a.s.

Strakonice, , 386 01

Nemocnice Strakonice a.s., Strakonice, Czechia

Status

Recruiting

Address

Nemocnice Strakonice a.s.

Strakonice, , 386 01

Royal University Hospital, Saskatoon, Saskatchewan, Canada

Status

Recruiting

Address

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8

Saskatoon City Hospital, Saskatoon, Saskatchewan, Canada

Status

Recruiting

Address

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K 0M7

London, Ontario, Canada

Status

Recruiting

Address

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5

Hamilton, Ontario, Canada

Status

Not yet recruiting

Address

Hamilton Health Sciences Corporation - MUMC Site

Hamilton, Ontario, L8N 3Z5

Leuven, Belgium

Status

Recruiting

Address

UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

Leuven, , 3000

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