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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004580-79 | EudraCT Number | ||
| OCTAVESUSTAIN | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator | Placebo Comparator |
| |
| CP-690,550 5 mg Arm | Experimental |
| |
| CP-690,550 10 mg Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo 10 mg orally (PO) twice a day (BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants In Remission at 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. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Mucosal Healing at 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. | Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internal Medicine Center, LLC | Mobile | Alabama | 36608 | United States | ||
| Springhill Memorial Hospital (Endoscopy Only) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38778549 | 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. | |
| 38425446 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib 5 mg BID | Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
| FG001 | Tofacitinib 10 mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| CP690,550 |
| Drug |
CP-690,550 5 mg orally (PO) twice a day (BID) |
|
| CP-690,550 | Drug | CP-690,550 10 mg orally (PO) twice a day (BID) |
|
| 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 |
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. |
| Week 24, 52 |
| Percentage of Participants in Remission at 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. | Week 24 |
| Percentage of Participants in Sustained Remission | 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. | Week 24, 52 |
| Percentage of Participants With Mucosal Healing at 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. | Week 24 |
| Percentage of Participants With Sustained Mucosal Healing | 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. | Week 24, 52 |
| Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | 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. | Week 24, 52 |
| Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline | 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. | Week 24, 52 |
| Percentage of Participants With Clinical Response at Week 24 and 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. | Week 24, 52 |
| Percentage of Participants With Sustained Clinical Response | 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. | Week 24, 52 |
| Percentage of Participants in Clinical Remission at Week 24 and 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. | Week 24, 52 |
| Percentage of Participants in Sustained Clinical Remission | 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. | Week 24, 52 |
| Percentage of Participants in Deep Remission at Week 24 and 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. | Week 24, 52 |
| Percentage of Participants in Sustained Deep Remission | 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. | Week 24, 52 |
| Percentage of Participants in Symptomatic Remission at Week 24 and 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. | Week 24, 52 |
| Percentage of Participants in Sustained Symptomatic Remission | 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. | Week 24, 52 |
| Percentage of Participants in Endoscopic Remission at Week 24 and 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. | Week 24, 52 |
| Percentage of Participants in Sustained Endoscopic Remission | 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. | Week 24, 52 |
| Total Mayo Score at Baseline, Week 24 and 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. | Baseline, Week 24, 52 |
| Change From Baseline in Total Mayo Score at Week 24 and 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. | Baseline, Week 24, 52 |
| Percentage of Participants in Remission, Among Participants With Remission at Baseline | 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. | Week 24, 52 |
| Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline | 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. | Week 24, 52 |
| Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | 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. | Week 24, 52 |
| Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | 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. | Week 24, 52 |
| Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | 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. | Week 24, 52 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center | La Jolla | California | 92037-0845 | United States |
| UCSD Medical Center | La Jolla | California | 92093 | United States |
| Alliance Clinical Research | Oceanside | California | 92056 | United States |
| Desert Advanced Imaging | Palm Springs | California | 92262 | United States |
| Erik Palmer, DO | Palm Springs | California | 92262 | United States |
| Homan A Zadeh, MD, MPH | Palm Springs | California | 92262 | United States |
| Hope Square Surgical Center | Rancho Mirage | California | 92270 | United States |
| Sharp Rees-Stealy Medical Group, Inc. | San Diego | California | 92101 | United States |
| Clinical Applications Laboratories, Inc | San Diego | California | 92103 | United States |
| San Diego Endoscopy Center | San Diego | California | 92103 | United States |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92123 | United States |
| UCSF Endoscopy Unit at Mount Zion | San Francisco | California | 94115 | United States |
| University of California San Francisco | San Francisco | California | 94115 | United States |
| Bristol Hospital | Bristol | Connecticut | 06010 | United States |
| Connecticut Clinical Research Foundation | Bristol | Connecticut | 06010 | United States |
| Endoscopy Center of Connecticut, LLC | Guilford | Connecticut | 06437 | United States |
| Endoscopy Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| Gastroenterology Center of Connecticut, PC | Hamden | Connecticut | 06518 | United States |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| Central Connecticut Endoscopy Center | Plainville | Connecticut | 06062 | United States |
| Citrus Surgery & Endoscopy Center (colonoscopy) | Crystal River | Florida | 34429 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| Suncoast Endoscopy Center (colonoscopy) | Inverness | Florida | 34453 | United States |
| North Florida Gastroenterology Research, LLC | Orange Park | Florida | 32073 | United States |
| Citrus Ambulatory Surgery Center | Orlando | Florida | 32806 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| Advanced Gastroenterology Center | Port Orange | Florida | 32127 | United States |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States |
| Endoscopy Center | Port Orange | Florida | 32127 | United States |
| Port Orange Urgent Care | Port Orange | Florida | 32127 | United States |
| Florida Medical Clinic, P.A. | Zephyhills | Florida | 33542 | United States |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | 33542 | United States |
| Georgia Endoscopy Center | Alpharetta | Georgia | 30005 | United States |
| GI Consultants | Atlanta | Georgia | 30342 | United States |
| Emory Healthcare Heart Center | Johns Creek | Georgia | 30097 | United States |
| Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | 31201 | United States |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | United States |
| Johns Creek Diagnostic Center | Suwanee | Georgia | 30024 | United States |
| Cotton-O'Neal Clinical Research Center Digestive Health | Topeka | Kansas | 66606 | United States |
| Digestive Disease Associates, PA | Baltimore | Maryland | 21229 | United States |
| Gastrointestinal Diagnostic Center | Baltimore | Maryland | 21229 | United States |
| Digestive Disease Associates, PA | Catonsville | Maryland | 21228 | United States |
| Howard County GIDC | Columbia | Maryland | 21044 | United States |
| Saint Joseph Mercy Hospital - Inpatient Pharmacy | Ann Arbor | Michigan | 48106 | United States |
| East Ann Arbor Health and Geriatrics Center - UMHS | Ann Arbor | Michigan | 48109-2701 | United States |
| University of Michigan Health Systems | Ann Arbor | Michigan | 48109-5000 | United States |
| Michigan Clinical Research Unit - UMHS | Ann Arbor | Michigan | 48109-5872 | United States |
| Medical Science Research Building 1 - UMHS | Ann Arbor | Michigan | 48109 | United States |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Surgical Centers of Michigan | Troy | Michigan | 48098 | United States |
| Utica Surgery Center (Endoscopy Only) | Utica | Michigan | 48317 | United States |
| Michigan Heart SJMH | Ypsilanti | Michigan | 48106 | United States |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | United States |
| Saint Joseph Mercy Hospital Outpatient Laboratory | Ypsilanti | Michigan | 48197 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| AGA Clinical Research Associates, LLC | Egg Harbour Township | New Jersey | 08234 | United States |
| South Jersey Gastroenterology | Marlton | New Jersey | 08053 | United States |
| The Endo Center at Voorhees | Vorhees | New Jersey | 08043 | United States |
| NYU Langone Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| NYU Langone Nassau Gastroenterology Associates | Great Neck | New York | 11021 | United States |
| The Private Practice of Simon Lichtiger, MD | New York | New York | 10028 | United States |
| IBD Center - The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| CUMC Research Pharmacy | New York | New York | 10032 | United States |
| Kornbluth, Legnani, George MD, PC | New York | New York | 10128 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Carolina Research, Carolina Digestive Diseases | Greenville | North Carolina | 27834 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195-0001 | United States |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | United States |
| Mentor Medical Campus | Mentor | Ohio | 44060 | United States |
| The Endoscopy Center of Lake County | Mentor | Ohio | 44060 | United States |
| Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania | 17604 | United States |
| Professional Quality Research, Inc.- Austin Gastroenterology PA | Austin | Texas | 78705 | United States |
| Austin Endoscopy Center II | Austin | Texas | 78745 | United States |
| Austin Gastroenterology PA | Austin | Texas | 78745 | United States |
| Houston Hospital for Specialized Surgery (Endoscopy only) | Houston | Texas | 77004 | United States |
| Baylor College of Medicine (Baylor Medical Center) | Houston | Texas | 77030 | United States |
| Baylor College of Medicine - Baylor Medical Center (Drug Storage) | Houston | Texas | 77030 | United States |
| McGovern Medical School -The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | United States |
| Alpine Medical Group | Salt Lake City | Utah | 84102 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Wasatch Endoscopy Center | Salt Lake City | Utah | 84124 | United States |
| VCU Health System Digestive Health Center | Richmond | Virginia | 23298 | United States |
| VCU Health System Endoscopy Suite | Richmond | Virginia | 23298 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| The Center for Digestive Health | Milwaukee | Wisconsin | 53215 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Eastern Health-Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| AKH Wien, Universitaetsklinik fuer Innere Medizin III | Vienna | State of Vienna | 1090 | Austria |
| GZA St. Vincentius | Antwerp | 2018 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven (University Hospital Leuven), Campus Gasthuisberg | Leuven | 3000 | Belgium |
| H-Hartziekenhuis Roeselare-Menen vzw | Roeselare | 8800 | Belgium |
| Hospital de Clinicas de Porto Alegre - HCPA | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre | Edmonton | Alberta | T6G 2B7 | Canada |
| University of Alberta - Zeidler Ledcor Centre | Edmonton | Alberta | T6G 2X8 | Canada |
| McMaster University Medical Center | Hamilton | Ontario | L8N 3Z5 | Canada |
| London Health Sciences Centre - University Hospital | London | Ontario | N6A 5A5 | Canada |
| Montreal General Hospital - McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada |
| Saskatoon City Hospital | Saskatoon | Saskatchewan | S7K 0M7 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Instituto de Coloproctología ICO S.A.S. | Medellín | Antioquia | 00000 | Colombia |
| University Hospital Center Zagreb | Zagreb | 10 000 | Croatia |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | 500 12 | Czechia |
| Nemocnice Strakonice, a.s., Interni oddeleni | Strakonice | 386 29 | Czechia |
| Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem | Ústí nad Labem | 40113 | Czechia |
| Aalborg Hospital | Aalborg | 9000 | Denmark |
| Aarhus University Hospital | Aarhus C | 8000 | Denmark |
| Bispebjerg Hospital | Copenhagen NV | 2400 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Odense University Hospital | Odense C | 5000 | Denmark |
| ECG Unit of West Tallinn Central Hospital | Tallinn | Estonia | 10617 | Estonia |
| West Tallinn Central Hospital | Tallinn | Estonia | 10617 | Estonia |
| X- Ray Department of West Tallinn Central Hospital | Tallinn | Estonia | 10617 | Estonia |
| X-Ray Unit, East Tallinn Central Hospital | Tallinn | 101 38 | Estonia |
| ECG Unit, Innomedica OU and Qualitas AS (ECG Only) | Tallinn | 10117 | Estonia |
| Innomedica OU | Tallinn | 10117 | Estonia |
| East Tallinn Central Hospital Internal Medical Clinic | Tallinn | 10138 | Estonia |
| ECG Unit, East Tallinn Central Hospital | Tallinn | 10138 | Estonia |
| X-Ray Department of West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| Mammograaf OU (Endoscopy Only) | Tallinn | 13419 | Estonia |
| CHU Amiens PICARDIE - Hopital SUD | Amiens | 80054 | France |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| Hopital Beaujon | Clichy | 92110 | France |
| Hotel-Dieu CHU Nantes | Nantes | 44093 | France |
| Hopital Saint Louis - Service d'hepato-gastoenterologie | Paris | 75010 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital Saint Antoine - Service de Gastroenterologie | Paris | 75571 | France |
| C.H.U. de Reims - Hôpital Robert Debré | Reims | 51092 | France |
| Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Kiel | Schlewig Holstein | 24105 | Germany |
| Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, | Berlin | 13353 | Germany |
| Universitätsklinikum Halle | Halle | 06120 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Klinikum Lüneburg/Abteilung Gastroenterologie | Lüneburg | 21339 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| Universitaetsklinikum Ulm | Ulm | 89081 | Germany |
| Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat | Békéscsaba | Hungary | 5600 | Hungary |
| Szent Margit Korhaz - III Belgyogyaszat | Budapest | 1032 | Hungary |
| Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont | Budapest | 1076 | Hungary |
| Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak | Budapest | 1125 | Hungary |
| Pannonia Maganorvosi Centrum Kft. | Budapest | H-1135 | Hungary |
| Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek | Debrecen | 4032 | Hungary |
| Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly | Gyula | 5700 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz | Miskolc | 3526 | Hungary |
| Karolina Korhaz | Mosonmagyaróvár | 9200 | Hungary |
| Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs | 7624 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika | Szeged | 6720 | Hungary |
| Javorszky Odon Korhaz | Vác | 2600 | Hungary |
| Rambam Health Care Campus | Haifa | 31096 | Israel |
| Rabin Medical Center, Beilinson campus | Petah Tikva | 49100 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Istituto Clinico Humanitas IRCSS | Rozzano | Milano | 20089 | Italy |
| AOR Villa Sofia-Cervello | Palermo | PA | 90146 | Italy |
| AOU Mater Domini - U.O. Fisiopatologia Digestiva | Catanzaro | 88100 | Italy |
| Aichi Medical University Hospital | Nagakute | Aichi-ken | 480-1195 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital | Sapporo | Hokkaido | 060-0033 | Japan |
| The Hospital of Hyogo College of Medicine | Nishinomiya | Hyōgo | 663-8501 | Japan |
| National Hospital Organization Mito Medical Center | Higashi-ibaraki-gun | Ibaraki | 311-3193 | Japan |
| Sameshima Hospital | Kagoshima | Kagoshima-ken | 892-0846 | Japan |
| Kuniyoshi Hospital | Kochi | Kochi | 780-0901 | Japan |
| National Hospital Organization Sendai Medical Center | Sendai | Miyagi | 983-8520 | Japan |
| Osaka City University Hospital | Osaka | Osaka | 545-8586 | Japan |
| Osaka Medical College Hospital | Takatsuki-shi | Osaka | 569-8686 | Japan |
| Shiga University of Medical Science Hospital | Ōtsu | Shiga | 520-2192 | Japan |
| Tokyo Medical And Dental University Hospital, Faculty of Medicine | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Tokai University Hachioji Hospital | Hachiōji | Tokyo | 192-0032 | Japan |
| Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo | 108-8642 | Japan |
| NTT Medical Center Tokyo | Shinagawa-ku | Tokyo | 141-8625 | Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Chiba University Hospital | Chiba | 260-8677 | Japan |
| Toho University Sakura Medical Center | Chiba | 285-8741 | Japan |
| Kurume University Hospital | Fukuoka | 830-0011 | Japan |
| ECG room Clinic Linezers (ECG only) Riga East University Hospital | Riga | LV-1006 | Latvia |
| X-Ray Department, Clinic Linezers (radiology only) | Riga | LV-1006 | Latvia |
| Digestive Diseases Center GASTRO | Riga | LV1006 | Latvia |
| VU University Medical Center (VUMC) | Amsterdam | 1081 HV | Netherlands |
| Academic Medical Centre | Amsterdam | 1105 AZ | Netherlands |
| University Medical Center Groningen (UMCG) | Groningen | 9713 GZ | Netherlands |
| Leiden University Medical Center (LUMC) | Leiden | 2333 ZA | Netherlands |
| Shakespeare Specialist Group | Milford | Auckland | 0620 | New Zealand |
| Tauranga Hospital | Tauranga | Bay of Plenty | 3143 | New Zealand |
| Christchurch Hospital | Christchurch | Canterbury | 8011 | New Zealand |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Southern District Health Board | Dunedin | 9016 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| P3 Research Limited | Wellington | 6021 | New Zealand |
| Pacific Radiology (X-rays only) | Wellington | 6021 | New Zealand |
| Bowen Hospital | Wellington | 6035 | New Zealand |
| Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o. | Lodz | Iodzkie | 90-302 | Poland |
| Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-168 | Poland |
| Klinika Chorob Wewnetrznych i Gastroenterologii z | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| H-T. Centrum Medyczne - ENDOTERAPIA | Tychy | Silesian Voivodeship | 43-100 | Poland |
| Gabinet Lekarski - Janusz Rudzinski | Bydgoszcz | 85-681 | Poland |
| Gabinet Endoskopii Przewodu Pokarmowego | Krakow | 31-009 | Poland |
| Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital | Lodz | 90-153 | Poland |
| Endoskopia Sp. Z O.O. | Sopot | 81-756 | Poland |
| Nzoz Vivamed | Warsaw | 03-580 | Poland |
| Lexmedica | Wroclaw | 53-114 | Poland |
| Cabinet Particular Policlinic Algomed Srl | Timișoara | Timiș County | 300002 | Romania |
| Spitalul Universitar de Urgenta Bucharest | Bucharest | 050098 | Romania |
| Municipal Institution of Healthcare City Clinical Hospital 12, | Saratov | Russia | 410039 | Russia |
| Federal state budget institution "State scientific centre of coloproctology" | Moscow | 123423 | Russia |
| State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A. | Nizhny Novgorod | 603126 | Russia |
| Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency", | Novosibirsk | 630068 | Russia |
| Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12" | Novosibirsk | 630084 | Russia |
| State Budget Educational Institution of Higher Professional Education | Novosibirsk | 630091 | Russia |
| Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental | Novosibirsk | 630117 | Russia |
| Non-State Healthcare Institution "Road Clinical Hospital at the station Samara" | Samara | 443029 | Russia |
| Limited Liability Company Medical Company "Hepatolog" | Samara | 443063 | Russia |
| Limited Liability Company Medical Company "Hepatolog" | Samara | 443093 | Russia |
| Samara Diagnostic center, X-ray Department | Samara | 443093 | Russia |
| State budget institution of healthcare of Yaroslavl region Regional clinical hospital | Yaroslavl | 150062 | Russia |
| Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology | Belgrade | Serbia, Europe | 11000 | Serbia |
| Clinical Hospital Centre Zvezdara | Belgrade | 11000 | Serbia |
| Military Medical Academy Belgrade | Belgrade | 11000 | Serbia |
| Clinical Centre of Kragujevac | Kragujevac | 34000 | Serbia |
| Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology | Novi Sad | 21000 | Serbia |
| Clinical Centre of Vojvodina, Emergency Internal Medicine Division | Novi Sad | 21000 | Serbia |
| "General Hospital ""Djordje Joanovic"" | Zrenjanin | 23000 | Serbia |
| Medak s.r.o. | Bratislava | 851 01 | Slovakia |
| KM Management spol. s.r.o. | Nitra | 949 01 | Slovakia |
| Aura SA, s.r.o. | Nové Mesto nad Váhom | 91501 | Slovakia |
| Gastro I., s.r.o. | Prešov | 080 01 | Slovakia |
| Dr John Philip Wright | Claremont | Cape Town | 7708 | South Africa |
| Chris Hani Baragwanath Academic Hospital | Johannesburg | Gauteng | 2013 | South Africa |
| Panorama MediClinic | Cape Town | Western Cape | 7500 | South Africa |
| Louis Leipoldt Medical Centre | Cape Town | Western Cape | 7530 | South Africa |
| Endocare Research Centre | Western Cape | 7646 | South Africa |
| Hanyang University Guri Hospital | Guri-si | Gyeonggi-do | 471-701 | South Korea |
| KyungHee University Hospital | Seoul | Republic of Korea | 130-872 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul National University Hospital, | Seoul | 110-744 | South Korea |
| Hospital Universitari de Bellvitge, Servicio de Digestivo | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario de Fuenlabrada | Madrid | 28942 | Spain |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community" | Simferopol | Ar Krym | 95017 | Ukraine |
| Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department | Kharkiv | Ukraine | 61037 | Ukraine |
| SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department, | Odesa | Ukraine | 65010 | Ukraine |
| Regional Municipal Institution "Chernivtsi Regional Clinical Hospital" | Chernivtsi | 58001 | Ukraine |
| Regional Municipal Institution Chernivtsi Regional Clinical Hospital, | Chernivtsi | 58001 | Ukraine |
| State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of | Dniepropetrovsk | 49074 | Ukraine |
| State Institution "National L.T. Malaya Therapy Institute of National Academy of | Kharkiv | 61039 | Ukraine |
| Kyiv Municipal Clinical Hospital #18, Proctology Department | Kyiv | 01030 | Ukraine |
| LTD "St. Paraskeva Medical Center" | Lviv | 79019 | Ukraine |
| Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital, | Lviv | 79059 | Ukraine |
| Municipal Institution "Odesa Regional Clinical Hospital" | Odesa | 65025 | Ukraine |
| SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat. | Uzhhorod | 88009 | Ukraine |
| Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2, | Vinnytsia | 21005 | Ukraine |
| Motor-Sich clinic, LLC | Zaporizhzhia | 69068 | Ukraine |
| Minicipal Institution City Hospital 7, Therapevtic Department, | Zaporizhzhia | 69118 | Ukraine |
| Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University | Zaporizhzhia | 69118 | Ukraine |
| Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust | Cambridge | Cambridgeshire | CB20QQ | United Kingdom |
| Department of Gastroenterology, Old Building | Bristol | England | BS2 8HW | United Kingdom |
| University College Hospital | London | Greater London | NW1 2BU | United Kingdom |
| NWLH NHS trust | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| The North West London Hospitals NHS Trust | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| 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. |
| 37560161 | Derived | Rubin DT, Salese L, Cohen M, Kotze PG, Woolcott JC, Su C, Mundayat R, Paulissen J, Torres J, Long MD. Presence of risk factors associated with colectomy among patients with ulcerative colitis: a post hoc analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program. Ther Adv Gastroenterol. 2023 Aug 7;16:17562848231189122. doi: 10.1177/17562848231189122. eCollection 2023. |
| 37402275 | Derived | Schreiber S, Rubin DT, Ng SC, Peyrin-Biroulet L, Danese S, Modesto I, Guo X, Su C, Kwok KK, Jo H, Chen Y, Yndestad A, Reinisch W, Dubinsky MC. Major Adverse Cardiovascular Events by Baseline Cardiovascular Risk in Patients with Ulcerative Colitis Treated with Tofacitinib: Data from the OCTAVE Clinical Programme. J Crohns Colitis. 2023 Nov 24;17(11):1761-1770. doi: 10.1093/ecco-jcc/jjad104. |
| 36931693 | Derived | Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17. |
| 36755231 | Derived | Lee SD, Allegretti JR, Steinwurz F, Connelly SB, Lawendy N, Paulissen J, Gecse KB. Tofacitinib as a maintenance therapy in patients with ulcerative colitis stratified by OCTAVE Sustain baseline Mayo endoscopic subscore. BMC Gastroenterol. 2023 Feb 8;23(1):34. doi: 10.1186/s12876-022-02508-2. |
| 36526796 | Derived | Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17. |
| 36506749 | Derived | Sandborn WJ, Sands BE, Vermeire S, Leung Y, Guo X, Modesto I, Su C, Wang W, Panes J. Modified Mayo score versus Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data from the tofacitinib OCTAVE program. Ther Adv Gastroenterol. 2022 Dec 5;15:17562848221136331. doi: 10.1177/17562848221136331. eCollection 2022. |
| 36342120 | Derived | 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. |
| 36336750 | Derived | 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. |
| 36271912 | Derived | Targownik L, Dubinsky MC, Steinwurz F, Bushmakin AG, Cappelleri JC, Tai E, Gardiner S, Hur P, Panes J. Disease Activity and Health-related Quality of Life Relationships with Work Productivity in Patients with Ulcerative Colitis in OCTAVE Induction 1 and 2 and OCTAVE Sustain. J Crohns Colitis. 2023 Apr 19;17(4):513-523. doi: 10.1093/ecco-jcc/jjac161. |
| 36124702 | 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. |
| 35792493 | Derived | Loftus EV, Baumgart DC, Gecse K, Kinnucan JA, Connelly SB, Salese L, Su C, Kwok KK, Woolcott JC, Armuzzi A. Clostridium difficile Infection in Patients with Ulcerative Colitis Treated with Tofacitinib in the Ulcerative Colitis Program. Inflamm Bowel Dis. 2023 May 2;29(5):744-751. doi: 10.1093/ibd/izac139. |
| 35648151 | 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. |
| 35574426 | Derived | 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. Ther Adv Gastroenterol. 2022 May 10;15:17562848221090834. doi: 10.1177/17562848221090834. eCollection 2022. |
| 35380740 | Derived | 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. |
| 34614208 | Derived | 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. |
| 34165201 | Derived | 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. |
| 34035832 | Derived | 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. Ther Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021. |
| 33884415 | Derived | 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. |
| 33684552 | Derived | 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. |
| 33513294 | Derived | 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. |
| 33324993 | Derived | 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. |
| 33039585 | Derived | 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. |
| 32870265 | Derived | 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. |
| 32816215 | Derived | 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. |
| 32766762 | Derived | 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. |
| 31599001 | Derived | 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. |
| 31077827 | Derived | 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. |
| 30476584 | Derived | 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. |
| 29850873 | Derived | 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. |
| 29743836 | Derived | 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. |
| 29028981 | Derived | 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. |
| 28467869 | Derived | 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. |
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
| FG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib 5 mg BID | Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
| BG001 | Tofacitinib 10 mg BID | Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
| BG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants In Remission at 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With Mucosal Healing at 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | 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 | 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. | FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Remission at 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants in Sustained Remission | 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants With Mucosal Healing at 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Sustained Mucosal Healing | 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | 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. | FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline | 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. | FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants With Clinical Response at Week 24 and 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants With Sustained Clinical Response | 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Clinical Remission at Week 24 and 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Sustained Clinical Remission | 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Deep Remission at Week 24 and 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Sustained Deep Remission | 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Symptomatic Remission at Week 24 and 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Sustained Symptomatic Remission | 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Endoscopic Remission at Week 24 and 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Sustained Endoscopic Remission | 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. | FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Total Mayo Score at Baseline, Week 24 and 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. | FAS included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24, 52 |
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| Secondary | Change From Baseline in Total Mayo Score at Week 24 and 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. | FAS included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 24, 52 |
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| Secondary | Percentage of Participants in Remission, Among Participants With Remission at Baseline | 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. | FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline | 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. | FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | 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. | FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | 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. | FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24, 52 |
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| Secondary | Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | 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. | FAS included all randomized participants. Here "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 24, 52 |
|
Baseline up to Week 57
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis included all treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib 5 mg BID | Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | 10 | 198 | 87 | 198 | ||
| EG001 | Tofacitinib 10 mg BID | Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | 11 | 196 | 107 | 196 | ||
| EG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | 13 | 198 | 108 | 198 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment | This AE was gender specific. |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v19.0 | Non-systematic Assessment | This AE was gender specific. |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
Not provided
Not provided
Not provided
| Male |
|
P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI. |
| CMH chi-square test |
| <0.0001 |
| Difference in percentage |
| 29.5 |
| 2-Sided |
| 95 |
| 21.4 |
| 37.6 |
| Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 |
| Tofacitinib 10 mg BID |
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
| OG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
|
|
|
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| OG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
| OG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
|
|
|
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
|
|
|
| Placebo |
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
| Placebo |
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
| Placebo |
Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
| OG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
| OG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
| OG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|
Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
| OG002 | Placebo | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
|
|
|