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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004581-14 | EudraCT Number | ||
| OCTAVEOPEN | Other Identifier | Alias Study Number |
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This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-690,550 5 mg BID | Experimental | 5 mg BID |
|
| CP-690,550 10 mg BID | Experimental | 10 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 | Drug | 5 mg tablets, BID, for at least 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
| Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) | Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
| Number of Participants With Laboratory Test Abnormalities | Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases | Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. |
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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 |
|---|---|---|---|---|---|---|
| Alabama Medical Group, P.C. | Mobile | Alabama | 36608 | United States | ||
| Desert Sun Clinical Research, LLC |
| 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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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Treatment failure for Study A3921096 was an increase in Mayo score of >=3 points from baseline value, with an increase in rectal bleeding sub score by >=1 point, and an increase of endoscopic sub score of >=1 point after a minimum of 8 weeks treatment. If endoscopic sub score and baseline endoscopic sub score was 3 (maximum value), then an increase by >=1 point was not needed for treatment failure. But all other components of the treatment failure criteria were needed to be met.
Participants enrolled in this Study A3921139: 1) who had completed or had early withdrawal due to treatment failure in Study A3921096 (NCT01458574) 2) or who were non-responders after completing induction studies A3921094 (NCT01465763) or A3921095 (NCT01458951). Eligible participants assigned to either Tofacitinib 5 mg BID or 10 mg BID depending if participant was in remission at baseline of A3921139. Remission=total Mayo score <=2 with no individual sub score >1, rectal bleeding sub score =0.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib 5 mg BID | Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139. |
| FG001 | Tofacitinib 10 mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2019 | Aug 3, 2021 |
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| CP-690,550 |
| Drug |
10 mg tablets, BID, for at least 12 months |
|
| Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
| Number of Participants With Vital Sign Abnormalities | Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM). | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
| Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline | Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator. | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond). | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
| Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events | Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs). | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
| Months 2, 12, 24 and 36 |
| Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. | Months 2, 12, 24 and 36 |
| Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases | Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. | Months 2, 12, 24 and 36 |
| Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. | Months 2, 12, 24 and 36 |
| Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases | PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1. | Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1. | Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases | Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity. | Months 2, 12, 24 and 36 |
| Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity. | Months 2, 12, 24 and 36 |
| Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL. | Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84 |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Desert Sun Gastroenterology | Tucson | Arizona | 85710 | United States |
| Desert Sun Surgery Center | Tucson | Arizona | 85710 | United States |
| Altman Clinical and Translational Research Institute | La Jolla | California | 92037-0897 | United States |
| Perlman Medical Offices - UC San Diego Health System | La Jolla | California | 92037 | United States |
| UCSD Medical Center | La Jolla | California | 92093 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Cedars Sinai Surgery Center | Los Angeles | California | 90048 | United States |
| Alliance Clinical Research | Oceanside | California | 92056 | United States |
| Center for Endoscopy- Covenant Surgical Partners | Oceanside | California | 92056 | United States |
| Sharp Rees-Stealy Medical Group, Inc. | San Diego | California | 92101 | United States |
| Clinical Applications Laboratories, Inc | San Diego | California | 92103 | United States |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92123 | United States |
| UCSF Center for Colitis and Crohn's Disease | San Francisco | California | 94115 | United States |
| Connecticut Clinical Research Institute | 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 |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | 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. | Zephyrhills | Florida | 33542 | United States |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | United States |
| Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | 31201 | United States |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | United States |
| Cotton O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | United States |
| Digestive Disease Associates, PA | Catonsville | Maryland | 21228 | United States |
| Gastrointestinal Diagnostic Center | Catonsville | Maryland | 21228 | United States |
| MGG Group Co., Inc., Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Howard County GIDC | Columbia | Maryland | 21044 | United States |
| East Ann Arbor Health and Geriatrics Center -UMHS | Ann Arbor | Michigan | 48109-2701 | 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 |
| University of Michigan Health Systems | 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 |
| Huron Gastroenterology Associates - Center for Digestive Care | 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 Harbor | New Jersey | 08234 | United States |
| South Jersey Gastroenterology, P.A. | Marlton | New Jersey | 08053 | United States |
| The Gastroenterology Group of South Jersey | Vineland | New Jersey | 08360 | United States |
| NYU Langone Long Island Clinical Research Associates | Lake Success | New York | 11042 | 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 Irving Medical Center | 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 | United States |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-1375 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Baylor College of Medicine- Baylor Medical Center | 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 |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Alpine Medical Group | Salt Lake City | Utah | 84102 | United States |
| Salt Lake Regional Hospital | Salt Lake City | Utah | 84102 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | 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 |
| Center for Digestive Health | Milwaukee | Wisconsin | 53215 | United States |
| Wisconsin Center for Advanced Research - a division of GI Associates, LLC | Milwaukee | Wisconsin | 53215 | United States |
| The Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 2747 | Australia |
| Liverpool Hospital eastern Campus | Liverpool | New South Wales | 2170 | Australia |
| Eastern Health, Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Gastroenterology and Hepatology Unit | Clayton | Victoria | 3168 | Australia |
| Landeskrankenhaus Innsbruck | Innsbruck | 6020 | Austria |
| Krankenhaus Barmherzige Brueder St. Veit/Glan | Sankt Veit an der Glan | 9300 | Austria |
| AKH Wien, Universitaetsklinik fuer Innere Medizin III | 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 Calgary, Heritage Medical Research Clinic, TRW Building | Calgary | Alberta | T2N 4Z6 | Canada |
| 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 |
| Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny | Montreal | Quebec | H1T 2M4 | Canada |
| Montreal General Hospital - McGill University Health Care Centre | Montreal | Quebec | H3G 1A4 | Canada |
| Saskatoon City Hospital | Saskatoon | Saskatchewan | S7K 0M7 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Instituto de Coloproctologia 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 |
| Klinicke Centrum ISCARE I.V.F., Gastroenterologie | Prague | 170 04 | Czechia |
| Nemocnice Strakonice, a.s., Interni oddeleni | Strakonice | 386 29 | Czechia |
| Krajska Zdravotni, A.S., | Ústí nad Labem | 401 13 | Czechia |
| Bispebjerg Hospital | Copenhagen | NV | 2400 | Denmark |
| Aalborg Hospital | Aalborg | 9000 | Denmark |
| Aarhus University Hospital | Aarhus C | 8000 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Odense University Hospital | Odense C | 5000 | Denmark |
| West Tallinn Central Hospital | Tallinn | Harju | 10617 | Estonia |
| Innomedica OU | Tallinn | 10117 | Estonia |
| CHU Amiens-Picardie - Hopital Sud | Amiens | 80054 | France |
| Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive | Clichy | 92110 | France |
| CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie | Nantes | 44093 | France |
| Hôpital Saint Louis - Service d'hepato-gastroenterologie | Paris | 75010 | France |
| Hôpital Saint Louis | Paris | 75010 | France |
| Hopital Saint Antoine - Service de Gastroenterologie | Paris | 75571 | France |
| Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique | Pessac | 33604 | France |
| CHU de Reims - Hopital Robert Debre | Reims | 51092 | France |
| Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Hopital Rangueil | Toulouse | 31059 | France |
| Universitatsklinikum Schleswig-Holstein, Campus Kiel | Kiel | Schlewig Holstein | 24105 | Germany |
| Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit | Berlin | 13353 | Germany |
| Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I | Halle | 06120 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Klinikum Lüneburg | Lüneburg | 21339 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| University Hospital Munich-Grosshadern | Munich | 81377 | Germany |
| Universitaetsklinikum Ulm | Ulm | 89081 | Germany |
| Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'. | Békéscsaba | 5600 | Hungary |
| Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet | Budapest | 1076 | Hungary |
| Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly | Budapest | 1125 | Hungary |
| Pannonia Maganorvosi Centrum Kft. | Budapest | 1136 | Hungary |
| Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály | Budapest | H-1032 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia | 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 |
| The Edith Wolfson Medical Center/Gastroenterology Department | Holon | 58100 | Israel |
| Rabin Medical Center, Beilinson campus | Petah Tikva | 49100 | Israel |
| Istituto Clinico Humanitas IRCCS-IBD Center | 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 |
| National Hospital Organization Hirosaki National Hospital | Hirosaki | Aomori | 036-8545 | Japan |
| Toho University Sakura Medical Center | Sakura | Chiba | 285-8741 | Japan |
| Kurume University Hospital | Kurume | Fukuoka | 830-0011 | Japan |
| Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital | Sapporo | Hokkaido | 060-0033 | 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 |
| Jikei University Hospital | Minato-ku | Tokyo | 105-8471 | Japan |
| Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo | 108-8642 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Fukuoka University Chikushi Hospital | Fukuoka | 818-8502 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| The Hospital of Hyogo College of Medicine | Hyōgo | 663-8501 | Japan |
| Showa University Hospital | Tokyo | 142-8666 | Japan |
| Digestive Diseases Center GASTRO | Riga | LV-1006 | Latvia |
| VU University Medical Center | Amsterdam | 1081 HV | Netherlands |
| Academic Medical Center (AMC) | Amsterdam | 1105 AZ | Netherlands |
| University Medical Center Groningen (UMCG) | Groningen | 9713 GZ | Netherlands |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School | Tauranga | Bay of Plenty | 3112 | New Zealand |
| Christchurch Hospital | Christchurch | Canterbury | 8011 | New Zealand |
| North Shore Hospital (Waitemata District Health Board) | Auckland | 0620 | 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 |
| Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o. | Lodz | Iodzkie | 90-302 | Poland |
| Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-168 | Poland |
| Gabinet Lekarski - Janusz Rudzinski | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-681 | Poland |
| Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital | Bialystok | Podlaskie Voivodeship | 15-950 | Poland |
| H-T. Centrum Medyczne - ENDOTERAPIA | Tychy | Silesian Voivodeship | 43-100 | Poland |
| Gabinet Endoskopii Przewodu Pokarmowego | Krakow | 31-009 | Poland |
| Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr | 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, Medicina Interna II Gastroenterologie | Bucharest | 050098 | Romania |
| Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh" | Moscow | 123423 | Russia |
| State budget Healthcare Institution Moscow regional scientific research clinical institute | Moscow | 129110 | Russia |
| State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A. | Nizhny Novgorod | 603126 | Russia |
| Municipal Budget Institution of Healthcare of Novosibirsk | Novosibirsk | 630084 | Russia |
| Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental | Novosibirsk | 630117 | Russia |
| FSBI "Scientific Research Institute of Physiology and Fundamental Medicine" | Novosibirsk | 630117 | Russia |
| Non-State Healthcare Institution "Road Clinical Hospital at the station Samara" | Samara | 443029 | 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 |
| Military Medical Academy | Belgrade | Central Serbia | 11000 | Serbia |
| Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology | Belgrade | 11000 | Serbia |
| Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology | Kragujevac | 34000 | Serbia |
| Clinical Centre of Vojvodina Emergency Internal Medicine Division | Novi Sad | 21000 | Serbia |
| Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology | Novi Sad | 21000 | Serbia |
| General Hospital Djordje Joanovic | Zrenjanin | 23000 | Serbia |
| Medak s.r.o. | Bratislava | 85101 | Slovakia |
| "KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra | Nitra | 949 01 | Slovakia |
| Poliklinika Libris, Synergy group, a.s., | Nové Mesto nad Váhom | 915 01 | Slovakia |
| Gastro I., s.r.o. | Prešov | 080 01 | Slovakia |
| Chris Hani Baragwanath Academic Hospital | Johannesburg | Gauteng | 2013 | South Africa |
| Panorama Medi-Clinic | Cape Town | Western Cape | 7500 | South Africa |
| Louis Leipoldt Medical Centre | Cape Town | Western Cape | 7530 | South Africa |
| Dr JP Wright | Cape Town | Western Cape | 7708 | South Africa |
| Endocare Research Centre | Paarl | Western Cape | 7646 | South Africa |
| Hanyang University Guri Hospital | Guri-si | Gyeonggi-do | 11923 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Seoul National University Hospital, | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Corporacio Sanitaria Parc Tauli | Barcelona | 08208 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Regional Municipal Institution "Chernivtsi Regional Clinical Hospital" | Chernivtsi | 58001 | Ukraine |
| Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital' | Chernivtsi | 58001 | Ukraine |
| SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases | Dnipropetrovsk | 49074 | Ukraine |
| Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 | Kharkiv | 61037 | Ukraine |
| State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine" | 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", polyclinic department | Odesa | 65025 | Ukraine |
| "Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian | Odesa | 65059 | Ukraine |
| CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod | Uzhhorod | 88009 | Ukraine |
| Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2 | Vinnytsia | 21005 | Ukraine |
| Minicipal Institution City Hospital #7, Therapeutic Department, | Zaporizhzhia | 69118 | Ukraine |
| Bristol Royal Infirmary | Bristol | England | BS2 8HW | United Kingdom |
| Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | CB2 0QQ | United Kingdom |
| The North West London Hospitals NHS Trust | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk | NR4 7UY | United Kingdom |
| UCLH NIHR Clinical Research Facility | London | W1T 7HA | 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. |
| 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. |
| 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. |
| 36242764 | Derived | Biedermann L, Dubinsky MC, Vermeire S, Fellmann M, Gardiner S, Hur P, Mundayat R, Panes J, Rubin DT. Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open. Inflamm Bowel Dis. 2023 Sep 1;29(9):1370-1379. doi: 10.1093/ibd/izac222. |
| 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. |
| 35380664 | Derived | Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061. |
| 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. |
| 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. |
| 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. |
| 33127596 | Derived | Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27. |
| 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. |
| 31660640 | Derived | Sands BE, Armuzzi A, Marshall JK, Lindsay JO, Sandborn WJ, Danese S, Panes J, Bressler B, Colombel JF, Lawendy N, Maller E, Zhang H, Chan G, Salese L, Tsilkos K, Marren A, Su C. Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open. Aliment Pharmacol Ther. 2020 Jan;51(2):271-280. doi: 10.1111/apt.15555. Epub 2019 Oct 29. |
| 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. |
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139. |
| COMPLETED |
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| NOT COMPLETED |
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|
Full analysis set (FAS) included all participants who received at least 1 dose of study medication in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib 5 mg BID | Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139. |
| BG001 | Tofacitinib 10 mg BID | Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139. |
| BG002 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. | Safety analysis set (SAS) included all participants who received at least 1 dose of study medication in this study. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
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| Primary | Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) | Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. | SAS included all participants who received at least 1 dose of study medication in this study. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
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| Primary | Number of Participants With Laboratory Test Abnormalities | Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20. | SAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
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| Primary | Number of Participants With Vital Sign Abnormalities | Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM). | SAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified category. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
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| Primary | Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline | Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator. | SAS included all participants who received at least 1 dose of study medication in this study. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
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| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond). | SAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified category. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
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| Primary | Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events | Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs). | SAS included all participants who received at least 1 dose of study medication in this study. | Posted | Number | 95% Confidence Interval | pt with events/100 pts-yrs | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) |
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| Secondary | Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases | Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. | FAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied. | Posted | Count of Participants | Participants | Months 2, 12, 24 and 36 |
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| Secondary | Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. | FAS included all participants who received at least 1 dose of study medication in this study. NRI method was used for missing data except for visits after a participant advanced to other studies where LOCF method was used. | Posted | Count of Participants | Participants | Months 2, 12, 24 and 36 |
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| Secondary | Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases | Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. | FAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied. | Posted | Count of Participants | Participants | Months 2, 12, 24 and 36 |
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| Secondary | Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. | FAS included all participants who received at least 1 dose of study medication in this study. NRI method was used for missing data except for visits after a participant advanced to other studies where LOCF method was used. | Posted | Count of Participants | Participants | Months 2, 12, 24 and 36 |
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| Secondary | Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases | PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1. | FAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied. | Posted | Count of Participants | Participants | Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1. | FAS included all participants who received at least 1 dose of study medication in this study. Here, "Number analyzed" signifies participants evaluable at each specified time point. NRI method was used for missing data at all visits except for visits after a participant advanced to other studies and would reach the visits if the participant stayed in the study where LOCF method was used. | Posted | Count of Participants | Participants | Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases | Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity. | FAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied. | Posted | Count of Participants | Participants | Months 2, 12, 24 and 36 |
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| Secondary | Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity. | FAS included all participants who received at least 1 dose of study medication in this study. NRI method was used for missing data at all visits and LOCF method was used for visits after a participant advanced to next study. | Posted | Count of Participants | Participants | Months 2, 12, 24 and 36 |
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| Secondary | Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL. | FAS included all participants who received at least 1 dose of study medication in this study. Here, "Number analyzed" signifies participants evaluable at each specified time point. NRI method was used for missing data at all visits except for visits after a participant advanced to other studies and would reach the visits if the participant stayed in the study where LOCF method was used. | Posted | Count of Participants | Participants | Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84 |
|
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Same event may appear as both an AE and 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. Analysis performed on safety analysis set.
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 who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139. | 0 | 175 | 39 | 175 | 134 | 175 |
| EG001 | Tofacitinib 10 mg BID | Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139. | 6 | 769 | 147 | 769 | 550 | 769 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anal skin tags | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Colon dysplasia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cytomegalovirus hepatitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Herpes zoster meningitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Histoplasmosis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Femoroacetabular impingement | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Epstein-Barr virus associated lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hepatic angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Non-systematic Assessment |
| |
| Device loosening | Product Issues | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cervix haemorrhage uterine | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eosinophilic pustular folliculitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2020 | Aug 3, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
| Unspecified |
|
|
|
| OG001 | Tofacitinib 10 mg BID | Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
|
|
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
|
|