A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis (OCTAVE)

• ClinicalTrials.gov Identifier: NCT01458574
• Recruitment Status: Completed
• First Posted: October 25, 2011
• Results First Posted: May 18, 2017
• Last Update Posted: May 18, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis	Drug: Placebo; Drug: CP690,550; Drug: CP-690,550	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 593 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
• Actual Study Start Date: July 20, 2012
• Actual Primary Completion Date: May 27, 2016
• Actual Study Completion Date: May 27, 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Comparator	Drug: Placebo; Placebo 10 mg orally (PO) twice a day (BID)
Experimental: CP-690,550 5 mg Arm	Drug: CP690,550; CP-690,550 5 mg orally (PO) twice a day (BID)
Experimental: CP-690,550 10 mg Arm	Drug: CP-690,550; CP-690,550 10 mg orally (PO) twice a day (BID)

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants In Remission at Week 52 [ Time Frame: Week 52 ]
   Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.

Secondary Outcome Measures :

1. Percentage of Participants With Mucosal Healing at Week 52 [ Time Frame: Week 52 ]
   Mucosal healing in participants was defined by mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
2. Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline [ Time Frame: Week 24, 52 ]
   Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.
3. Percentage of Participants in Remission at Week 24 [ Time Frame: Week 24 ]
   Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
4. Percentage of Participants in Sustained Remission [ Time Frame: Week 24, 52 ]
   Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
5. Percentage of Participants With Mucosal Healing at Week 24 [ Time Frame: Week 24 ]
   Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
6. Percentage of Participants With Sustained Mucosal Healing [ Time Frame: Week 24, 52 ]
   Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
7. Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline [ Time Frame: Week 24, 52 ]
   Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
8. Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline [ Time Frame: Week 24, 52 ]
   Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
9. Percentage of Participants With Clinical Response at Week 24 and 52 [ Time Frame: Week 24, 52 ]
   Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.
10. Percentage of Participants With Sustained Clinical Response [ Time Frame: Week 24, 52 ]
    Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.
11. Percentage of Participants in Clinical Remission at Week 24 and 52 [ Time Frame: Week 24, 52 ]
    Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
12. Percentage of Participants in Sustained Clinical Remission [ Time Frame: Week 24, 52 ]
    Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
13. Percentage of Participants in Deep Remission at Week 24 and 52 [ Time Frame: Week 24, 52 ]
    Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
14. Percentage of Participants in Sustained Deep Remission [ Time Frame: Week 24, 52 ]
    Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
15. Percentage of Participants in Symptomatic Remission at Week 24 and 52 [ Time Frame: Week 24, 52 ]
    Symptomatic remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
16. Percentage of Participants in Sustained Symptomatic Remission [ Time Frame: Week 24, 52 ]
    Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
17. Percentage of Participants in Endoscopic Remission at Week 24 and 52 [ Time Frame: Week 24, 52 ]
    Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
18. Percentage of Participants in Sustained Endoscopic Remission [ Time Frame: Week 24, 52 ]
    Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
19. Total Mayo Score at Baseline, Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
    Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
20. Change From Baseline in Total Mayo Score at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
    Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.
21. Percentage of Participants in Remission, Among Participants With Remission at Baseline [ Time Frame: Week 24, 52 ]
    Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
22. Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline [ Time Frame: Week 24, 52 ]
    Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
23. Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline [ Time Frame: Week 24, 52 ]
    Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.
24. Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline [ Time Frame: Week 24, 52 ]
    Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.
25. Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline [ Time Frame: Week 24, 52 ]
    Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
• Subjects who achieved clinical response in Study A3921094 or A3921095
• Women of childbearing potential must test negative for pregnancy prior to study enrollment
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

• Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
• Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

Contacts and Locations

Locations

United States, Alabama

Internal Medicine Center, LLC

Mobile, Alabama, United States, 36608

Springhill Memorial Hospital (Endoscopy Only)

Mobile, Alabama, United States, 36608

United States, California

UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center

La Jolla, California, United States, 92037-0845

UCSD Medical Center

La Jolla, California, United States, 92093

Alliance Clinical Research

Oceanside, California, United States, 92056

Desert Advanced Imaging

Palm Springs, California, United States, 92262

Erik Palmer, DO

Palm Springs, California, United States, 92262

Homan A Zadeh, MD, MPH

Palm Springs, California, United States, 92262

Hope Square Surgical Center

Rancho Mirage, California, United States, 92270

Sharp Rees-Stealy Medical Group, Inc.

San Diego, California, United States, 92101

Clinical Applications Laboratories, Inc

San Diego, California, United States, 92103

San Diego Endoscopy Center

San Diego, California, United States, 92103

Sharp Rees-Stealy Medical Group

San Diego, California, United States, 92123

UCSF Endoscopy Unit at Mount Zion

San Francisco, California, United States, 94115

University of California San Francisco

San Francisco, California, United States, 94115

United States, Connecticut

Bristol Hospital

Bristol, Connecticut, United States, 06010

Connecticut Clinical Research Foundation

Bristol, Connecticut, United States, 06010

Endoscopy Center of Connecticut, LLC

Guilford, Connecticut, United States, 06437

Endoscopy Center of Connecticut, LLC

Hamden, Connecticut, United States, 06518

Gastroenterology Center of Connecticut, PC

Hamden, Connecticut, United States, 06518

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States, 06518

Central Connecticut Endoscopy Center

Plainville, Connecticut, United States, 06062

United States, Florida

Citrus Surgery & Endoscopy Center (colonoscopy)

Crystal River, Florida, United States, 34429

Nature Coast Clinical Research

Inverness, Florida, United States, 34452

Suncoast Endoscopy Center (colonoscopy)

Inverness, Florida, United States, 34453

North Florida Gastroenterology Research, LLC

Orange Park, Florida, United States, 32073

Citrus Ambulatory Surgery Center

Orlando, Florida, United States, 32806

Internal Medicine Specialists

Orlando, Florida, United States, 32806

Advanced Gastroenterology Center

Port Orange, Florida, United States, 32127

Advanced Medical Research Center

Port Orange, Florida, United States, 32127

Endoscopy Center

Port Orange, Florida, United States, 32127

Port Orange Urgent Care

Port Orange, Florida, United States, 32127

Florida Medical Clinic, P.A.

Zephyhills, Florida, United States, 33542

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States, 33542

United States, Georgia

Georgia Endoscopy Center

Alpharetta, Georgia, United States, 30005

GI Consultants

Atlanta, Georgia, United States, 30342

Emory Healthcare Heart Center

Johns Creek, Georgia, United States, 30097

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, United States, 31201

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, United States, 30024

Johns Creek Diagnostic Center

Suwanee, Georgia, United States, 30024

United States, Kansas

Cotton-O'Neal Clinical Research Center Digestive Health

Topeka, Kansas, United States, 66606

United States, Maryland

Digestive Disease Associates, PA

Baltimore, Maryland, United States, 21229

Gastrointestinal Diagnostic Center

Baltimore, Maryland, United States, 21229

Digestive Disease Associates, PA

Catonsville, Maryland, United States, 21228

Howard County GIDC

Columbia, Maryland, United States, 21044

United States, Michigan

Saint Joseph Mercy Hospital - Inpatient Pharmacy

Ann Arbor, Michigan, United States, 48106

East Ann Arbor Health and Geriatrics Center - UMHS

Ann Arbor, Michigan, United States, 48109-2701

University of Michigan Health Systems

Ann Arbor, Michigan, United States, 48109-5000

Michigan Clinical Research Unit - UMHS

Ann Arbor, Michigan, United States, 48109-5872

Medical Science Research Building 1 - UMHS

Ann Arbor, Michigan, United States, 48109

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States, 48047

Center for Digestive Health

Troy, Michigan, United States, 48098

Surgical Centers of Michigan

Troy, Michigan, United States, 48098

Utica Surgery Center (Endoscopy Only)

Utica, Michigan, United States, 48317

Michigan Heart SJMH

Ypsilanti, Michigan, United States, 48106

Huron Gastroenterology Associates

Ypsilanti, Michigan, United States, 48197

Saint Joseph Mercy Hospital Outpatient Laboratory

Ypsilanti, Michigan, United States, 48197

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New Hampshire

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

AGA Clinical Research Associates, LLC

Egg Harbour Township, New Jersey, United States, 08234

South Jersey Gastroenterology

Marlton, New Jersey, United States, 08053

The Endo Center at Voorhees

Vorhees, New Jersey, United States, 08043

United States, New York

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, United States, 11021

NYU Langone Nassau Gastroenterology Associates

Great Neck, New York, United States, 11021

The Private Practice of Simon Lichtiger, MD

New York, New York, United States, 10028

IBD Center - The Mount Sinai Hospital

New York, New York, United States, 10029

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Columbia University Medical Center

New York, New York, United States, 10032

CUMC Research Pharmacy

New York, New York, United States, 10032

Kornbluth, Legnani, George MD, PC

New York, New York, United States, 10128

University of Rochester

Rochester, New York, United States, 14642

United States, North Carolina

Carolina Research, Carolina Digestive Diseases

Greenville, North Carolina, United States, 27834

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195-0001

Great Lakes Gastroenterology

Mentor, Ohio, United States, 44060

Mentor Medical Campus

Mentor, Ohio, United States, 44060

The Endoscopy Center of Lake County

Mentor, Ohio, United States, 44060

United States, Pennsylvania

Regional Gastroenterology Associates of Lancaster, Ltd.

Lancaster, Pennsylvania, United States, 17604

United States, Texas

Professional Quality Research, Inc.- Austin Gastroenterology PA

Austin, Texas, United States, 78705

Austin Endoscopy Center II

Austin, Texas, United States, 78745

Austin Gastroenterology PA

Austin, Texas, United States, 78745

Houston Hospital for Specialized Surgery (Endoscopy only)

Houston, Texas, United States, 77004

Baylor College of Medicine (Baylor Medical Center)

Houston, Texas, United States, 77030

Baylor College of Medicine - Baylor Medical Center (Drug Storage)

Houston, Texas, United States, 77030

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

Houston, Texas, United States, 77030

Memorial Hermann Hospital

Houston, Texas, United States, 77030

Digestive Health Specialists of Tyler

Tyler, Texas, United States, 75701

United States, Utah

Alpine Medical Group

Salt Lake City, Utah, United States, 84102

Wasatch Clinical Research

Salt Lake City, Utah, United States, 84107

Wasatch Endoscopy Center

Salt Lake City, Utah, United States, 84124

United States, Virginia

VCU Health System Digestive Health Center

Richmond, Virginia, United States, 23298

VCU Health System Endoscopy Suite

Richmond, Virginia, United States, 23298

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

United States, Wisconsin

The Center for Digestive Health

Milwaukee, Wisconsin, United States, 53215

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States, 53215

Australia, New South Wales

Concord Repatriation General Hospital

Concord, New South Wales, Australia, 2139

Liverpool Hospital

Liverpool, New South Wales, Australia, 2170

Australia, Victoria

Eastern Health-Box Hill Hospital

Box Hill, Victoria, Australia, 3128

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Austria

AKH Wien, Universitaetsklinik fuer Innere Medizin III

Wien, Vienna, Austria, 1090

Belgium

GZA St. Vincentius

Antwerpen, Belgium, 2018

AZ Groeninge

Kortrijk, Belgium, 8500

UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

Leuven, Belgium, 3000

H-Hartziekenhuis Roeselare-Menen vzw

Roeselare, Belgium, 8800

Brazil

Hospital de Clinicas de Porto Alegre - HCPA

Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003

Canada, Alberta

University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

Edmonton, Alberta, Canada, T6G 2B7

University of Alberta - Zeidler Ledcor Centre

Edmonton, Alberta, Canada, T6G 2X8

Canada, Ontario

McMaster University Medical Center

Hamilton, Ontario, Canada, L8N 3Z5

London Health Sciences Centre - University Hospital

London, Ontario, Canada, N6A 5A5

Canada, Quebec

Montreal General Hospital - McGill University Health Centre

Montreal, Quebec, Canada, H3G 1A4

Canada, Saskatchewan

Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada, S7K 0M7

Royal University Hospital

Saskatoon, Saskatchewan, Canada, S7N 0W8

Colombia

Instituto de Coloproctología ICO S.A.S.

Medellin, Antioquia, Colombia, 00000

Croatia

University Hospital Center Zagreb

Zagreb, Croatia, 10 000

Czech Republic

Hepato-Gastroenterologie HK, s.r.o.

Hradec Kralove, Czech Republic, 500 12

Nemocnice Strakonice, a.s., Interni oddeleni

Strakonice, Czech Republic, 386 29

Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem

Usti nad Labem, Czech Republic, 40113

Denmark

Aalborg Hospital

Aalborg, Denmark, 9000

Aarhus University Hospital

Aarhus C, Denmark, 8000

Bispebjerg Hospital

Copenhagen NV, Denmark, 2400

Hvidovre Hospital

Hvidovre, Denmark, 2650

Odense University Hospital

Odense C, Denmark, 5000

Estonia

X-Ray Unit, East Tallinn Central Hospital

Tallinn, Estonia, 101 38

ECG Unit, Innomedica OU and Qualitas AS (ECG Only)

Tallinn, Estonia, 10117

Innomedica OU

Tallinn, Estonia, 10117

East Tallinn Central Hospital Internal Medical Clinic

Tallinn, Estonia, 10138

ECG Unit of West Tallinn Central Hospital

Tallinn, Estonia, 10617

West Tallinn Central Hospital

Tallinn, Estonia, 10617

X- Ray Department of West Tallinn Central Hospital

Tallinn, Estonia, 10617

X-Ray Department of West Tallinn Central Hospital

Tallinn, Estonia, 10617

Mammograaf OU (Endoscopy Only)

Tallinn, Estonia, 13419

ECG Unit, East Tallinn Central Hospital

Tallin, Estonia, 10138

France

CHU Amiens PICARDIE - Hopital SUD

Amiens Cedex 1, France, 80054

Hopital Saint Andre

Bordeaux cedex, France, 33075

Hopital Beaujon

Clichy Cedex, France, 92110

Hotel-Dieu CHU Nantes

Nantes cedex 01, France, 44093

Hopital Saint Antoine - Service de Gastroenterologie

Paris cedex 12, France, 75571

Hopital Saint Louis - Service d'hepato-gastoenterologie

Paris, France, 75010

Hopital Saint Louis

Paris, France, 75010

C.H.U. de Reims - Hôpital Robert Debré

Reims cedex, France, 51092

Hopital Nord

Saint Priest en Jarez, France, 42270

Germany

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Schlewig Holstein, Germany, 24105

Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

Berlin, Germany, 13353

Universitätsklinikum Halle

Halle, Germany, 06120

Medizinische Hochschule Hannover

Hannover, Germany, 30625

Klinikum Lüneburg/Abteilung Gastroenterologie

Lüneburg, Germany, 21339

Gastroenterologische Gemeinschaftspraxis Minden

Minden, Germany, 32423

Universitaetsklinikum Ulm

Ulm, Germany, 89081

Hungary

Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat

Bekescsaba, Hungary, 5600

Szent Margit Korhaz - III Belgyogyaszat

Budapest, Hungary, 1032

Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont

Budapest, Hungary, 1076

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, Hungary, 1125

Pannonia Maganorvosi Centrum Kft.

Budapest, Hungary, H-1135

Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek

Debrecen, Hungary, 4032

Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly

Gyula, Hungary, 5700

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, Hungary, 3526

Karolina Korhaz

Mosonmagyarovar, Hungary, 9200

Pecsi Tudomanyegyetem Klinikai Kozpont

Pecs, Hungary, 7624

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika

Szeged, Hungary, 6720

Javorszky Odon Korhaz

Vac, Hungary, 2600

Israel

Rambam Health Care Campus

Haifa, Israel, 31096

Rabin Medical Center, Beilinson campus

Petah Tikva, Israel, 49100

Kaplan Medical Center

Rehovot, Israel, 76100

Italy

Istituto Clinico Humanitas IRCSS

Rozzano, Milano, Italy, 20089

AOR Villa Sofia-Cervello

Palermo, PA, Italy, 90146

AOU Mater Domini - U.O. Fisiopatologia Digestiva

Catanzaro, Italy, 88100

Japan

Aichi Medical University Hospital

Nagakute, Aichi, Japan, 480-1195

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

Sapporo, Hokkaido, Japan, 060-0033

The Hospital of Hyogo College of Medicine

Nishinomiya, Hyogo, Japan, 663-8501

National Hospital Organization Mito Medical Center

Higashi-ibaraki-gun, Ibaraki, Japan, 311-3193

Sameshima Hospital

Kagoshima-shi, Kagoshima, Japan, 892-0846

Kuniyoshi Hospital

Kochi-shi, Kochi, Japan, 780-0901

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan, 983-8520

Osaka Medical College Hospital

Takatsuki-shi, Osaka, Japan, 569-8686

Shiga University of Medical Science Hospital

Otsu-shi, Shiga, Japan, 520-2192

Tokyo Medical And Dental University Hospital, Faculty of Medicine

Bunkyo-ku, Tokyo, Japan, 113-8519

Tokai University Hachioji Hospital

Hachioji, Tokyo, Japan, 192-0032

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan, 108-8642

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, Japan, 141-8625

Showa University Hospital

Shinagawa-ku, Tokyo, Japan, 142-8666

Keio University Hospital

Shinjuku-ku, Tokyo, Japan, 160-8582

Chiba University Hospital

Chiba, Japan, 260-8677

Toho University Sakura Medical Center

Chiba, Japan, 285-8741

Kurume University Hospital

Fukuoka, Japan, 830-0011

Hiroshima University Hospital

Hiroshima, Japan, 734-8551

Osaka City University Hospital

Osaka, Japan, 545-8586

Korea, Republic of

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, Korea, Republic of, 471-701

KyungHee University Hospital

Seoul, Republic of Korea, Korea, Republic of, 130-872

Gachon University Gil Medical Center

Incheon, Korea, Republic of, 405-760

Kyung Hee University Hospital

Seoul, Korea, Republic of, 02447

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Seoul National University Hospital,

Seoul, Korea, Republic of, 110-744

Latvia

ECG room Clinic Linezers (ECG only) Riga East University Hospital

Riga, Latvia, LV-1006

X-Ray Department, Clinic Linezers (radiology only)

Riga, Latvia, LV-1006

Digestive Diseases Center GASTRO

Riga, Latvia, LV1006

Netherlands

VU University Medical Center (VUMC)

Amsterdam, Netherlands, 1081 HV

Academic Medical Centre

Amsterdam, Netherlands, 1105 AZ

University Medical Center Groningen (UMCG)

Groningen, Netherlands, 9713 GZ

Leiden University Medical Center (LUMC)

Leiden, Netherlands, 2333 ZA

New Zealand

Shakespeare Specialist Group

Milford, Auckland, New Zealand, 0620

Tauranga Hospital

Tauranga, Bay of Plenty, New Zealand, 3143

Christchurch Hospital

Christchurch, Canterbury Region, New Zealand, 8011

Auckland City Hospital

Auckland, New Zealand, 1023

Southern District Health Board

Dunedin, New Zealand, 9016

Waikato Hospital

Hamilton, New Zealand, 3240

P3 Research Limited

Wellington, New Zealand, 6021

Pacific Radiology (X-rays only)

Wellington, New Zealand, 6021

Bowen Hospital

Wellington, New Zealand, 6035

Poland

Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

Lodz, Iodzkie, Poland, 90-302

Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im

Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168

Klinika Chorob Wewnetrznych i Gastroenterologii z

Warszawa, Mazowieckie, Poland, 02-507

H-T. Centrum Medyczne - ENDOTERAPIA

Tychy, Slaskie, Poland, 43-100

Gabinet Lekarski - Janusz Rudzinski

Bydgoszcz, Poland, 85-681

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, Poland, 31-009

Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital

Lodz, Poland, 90-153

Endoskopia Sp. Z O.O.

Sopot, Poland, 81-756

Nzoz Vivamed

Warszawa, Poland, 03-580

Lexmedica

Wroclaw, Poland, 53-114

Romania

Cabinet Particular Policlinic Algomed Srl

Timisoara, Timis, Romania, 300002

Spitalul Universitar de Urgenta Bucharest

Bucuresti, Romania, 050098

Russian Federation

Municipal Institution of Healthcare City Clinical Hospital 12,

Saratov, Russia, Russian Federation, 410039

Federal state budget institution "State scientific centre of coloproctology"

Moscow, Russian Federation, 123423

State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.

Nizhniy Novgorod, Russian Federation, 603126

Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",

Novosibirsk,, Russian Federation, 630068

Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"

Novosibirsk, Russian Federation, 630084

State Budget Educational Institution of Higher Professional Education

Novosibirsk, Russian Federation, 630091

Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental

Novosibirsk, Russian Federation, 630117

Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"

Samara, Russian Federation, 443029

Limited Liability Company Medical Company "Hepatolog"

Samara, Russian Federation, 443063

Limited Liability Company Medical Company "Hepatolog"

Samara, Russian Federation, 443093

Samara Diagnostic center, X-ray Department

Samara, Russian Federation, 443093

State budget institution of healthcare of Yaroslavl region Regional clinical hospital

Yaroslavl, Russian Federation, 150062

Serbia

Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

Belgrade, Serbia, Europe, Serbia, 11000

Clinical Hospital Centre Zvezdara

Belgrade, Serbia, 11000

Military Medical Academy Belgrade

Belgrade, Serbia, 11000

Clinical Centre of Kragujevac

Kragujevac, Serbia, 34000

Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

Novi Sad, Serbia, 21000

Clinical Centre of Vojvodina, Emergency Internal Medicine Division

Novi Sad, Serbia, 21000

"General Hospital ""Djordje Joanovic""

Zrenjanin, Serbia, 23000

Slovakia

Medak s.r.o.

Bratislava, Slovakia, 851 01

KM Management spol. s.r.o.

Nitra, Slovakia, 949 01

Aura SA, s.r.o.

Nove Mesto nad Vahom, Slovakia, 91501

Gastro I., s.r.o.

Presov, Slovakia, 080 01

South Africa

Dr John Philip Wright

Claremont, Cape Town, South Africa, 7708

Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, South Africa, 2013

Panorama MediClinic

Cape Town, Western Cape, South Africa, 7500

Louis Leipoldt Medical Centre

Cape Town, Western Cape, South Africa, 7530

Endocare Research Centre

Western Cape, South Africa, 7646

Spain

Hospital Universitari de Bellvitge, Servicio de Digestivo

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain, 08036

Hospital Clinico San Carlos

Madrid, Spain, 28040

Hospital Universitario de Fuenlabrada

Madrid, Spain, 28942

Taiwan

National Taiwan University Hospital

Taipei City, Taiwan, 10002

Ukraine

Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"

Simferopol, Ar Krym, Ukraine, 95017

Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

Chernivtsi, Ukraine, 58001

Regional Municipal Institution Chernivtsi Regional Clinical Hospital,

Chernivtsi, Ukraine, 58001

State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of

Dniepropetrovsk, Ukraine, 49074

Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department

Kharkiv, Ukraine, 61037

State Institution "National L.T. Malaya Therapy Institute of National Academy of

Kharkiv, Ukraine, 61039

Kyiv Municipal Clinical Hospital #18, Proctology Department

Kyiv, Ukraine, 01030

LTD "St. Paraskeva Medical Center"

Lviv, Ukraine, 79019

Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

Lviv, Ukraine, 79059

SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,

Odesa, Ukraine, 65010

Municipal Institution "Odesa Regional Clinical Hospital"

Odesa, Ukraine, 65025

SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.

Uzhgorod, Ukraine, 88009

Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,

Vinnytsia, Ukraine, 21005

Motor-Sich clinic, LLC

Zaporizhzhia, Ukraine, 69068

Minicipal Institution City Hospital 7, Therapevtic Department,

Zaporizhzhia, Ukraine, 69118

Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University

Zaporizhzhia, Ukraine, 69118

United Kingdom

Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom, CB20QQ

Department of Gastroenterology, Old Building

Bristol, England, United Kingdom, BS2 8HW

University College Hospital

London, Greater London, United Kingdom, NW1 2BU

NWLH NHS trust

Harrow, Middlesex, United Kingdom, HA1 3UJ

The North West London Hospitals NHS Trust

Harrow, Middlesex, United Kingdom, HA1 3UJ

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom, NR4 7UY

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 0QQ

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.

Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2023 Mar;16(2):95-103. doi: 10.1007/s40271-022-00603-w. Epub 2022 Nov 7.

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.

Vavricka SR, Greuter T, Cohen BL, Reinisch W, Steinwurz F, Fellmann M, Guo X, Lawendy N, Paulissen J, Peyrin-Biroulet L. Corticosteroid-free efficacy and safety outcomes in patients receiving tofacitinib in the OCTAVE Sustain maintenance study. Therap Adv Gastroenterol. 2022 May 10;15:17562848221090834. doi: 10.1177/17562848221090834. eCollection 2022.

Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

Panes J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.

Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.

Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum In: Intest Res. 2018 Jul;16(3):499-501.

Panes J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum In: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01458574
• Other Study ID Numbers: A3921096; 2011-004580-79 ( EudraCT Number ); OCTAVESUSTAIN ( Other Identifier: Alias Study Number )
• First Posted: October 25, 2011
• Results First Posted: May 18, 2017
• Last Update Posted: May 18, 2017
• Last Verified: April 2017

Keywords provided by Pfizer:

Janus kinase inhibitor; JAK 3 inhibitor; inflammatory bowel disease; ulcerative colitis; OCTAVE; CP-690; 550; tofacitinib; Xeljanz

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases; Tofacitinib; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action