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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001733-16 | EudraCT Number |
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This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo BID | Placebo Comparator |
| |
| 5mg BID | Experimental |
| |
| 10mg BID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | oral tablets twice daily |
| |
| CP-690,550 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8 | Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. |
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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 |
|---|---|---|---|---|---|---|
| ACRI - Phase 1, LLC | Anaheim | California | 92801 | United States | ||
| Advanced Clinical Research Institute - Phase 1, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28209624 | Derived | Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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280 participants were randomized to treatment but only 279 participants received treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo tablets to match tofacitinib 5 milligrams (mg) for oral administration twice daily (BID) for 8 weeks. |
| FG001 | Tofacitinib 5 mg BID | Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
oral tablets twice daily |
|
| CP-690,550 | Drug | oral tablets twice daily |
|
| Weeks 2 and 4 |
| Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8 | Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | Baseline, Weeks 2, 4, and 8 |
| Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8 | Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | Baseline, Weeks 2, 4, and 8 |
| Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | Baseline, Weeks 2, 4, and 8 |
| CDAI Scores at Weeks 2, 4, and 8 | CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. | Weeks 2, 4, and 8 |
| C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Weeks 2, 4, and 8 |
| Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. | Weeks 2, 4, and 8 |
| Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different. | Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit | The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QOL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL. | Baseline, Week 8/ET visit |
| Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA) | IBDQ is a validated PRO instrument for measuring QOL in IBD consisting of 32 items scored from 1 (worst response) to 7 (best response). 32 items are grouped into 4 domains scored as follows: bowel symptoms 10 - 70; systemic symptoms 5 - 35; emotional function 12 - 84; social function 5 - 35. For each domain, higher score indicates better QOL. Total score is the sum of each item score, & ranged from 32 to 224 with a higher score indicating better QOL. Positive change in total score indicated improvement in QOL. Adjusted means were derived from an ANCOVA model with baseline value as covariate, treatment group & prior use of anti-tumor necrosis factor (TNF) alpha (α) treatments as factors. The 15 mg BID treatment group was closed to further enrolment early in the study by Protocol Amendment 5 after only 16 participants were enrolled in this group. Therefore, the efficacy analysis was not performed for this group as the results may be difficult to interpret due to the small sample size. | Baseline, Week 8/ET visit |
| Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit | The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL. | Week 8/ET visit |
| Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit | The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL. | Week 8/ET visit |
| Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | The IBD Patient Reported Treatment Impact Modified (PRTI) questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to re-use the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment. | Week 8/ET visit |
| Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL. | Baseline, Week 8/ET visit |
| Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | Baseline, Week 8/ET visit |
| EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from -0.594 to 1.000; a higher score indicates a better health state. | Baseline, Week 8/ET visit |
| Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA | EQ-5D is a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFα treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | Baseline, Week 8/ET visit |
| EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | Baseline, Week 8/ET visit |
| Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA | EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | Baseline, Week 8/ET visit |
| Anaheim |
| California |
| 92801 |
| United States |
| AGMG Endoscopy Center | Anaheim | California | 92801 | United States |
| Alliance Clinical Research | Oceanside | California | 92056 | United States |
| Alliance Clinical Research, LLC | Poway | California | 92064 | United States |
| Sharp Rees-Stealy Medical Group, Inc. | San Diego | California | 92101 | United States |
| Sharp Rees-Stealy Medical Group, Inc. | San Diego | California | 92123 | United States |
| Clinical Research Of The Rockies | Lafayette | Colorado | 80026 | United States |
| Endoscopy Center of the Rockies - Longmont | Longmont | Colorado | 80501 | 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 |
| Metropolitan Gastroenterology Group, PC | Washington D.C. | District of Columbia | 20006 | United States |
| Gasteroenterology Consultants of Clearwater | Clearwater | Florida | 33756 | United States |
| West Coast Endoscopy Center | Clearwater | Florida | 33756 | United States |
| Clinical Research of West Florida, Inc | Clearwater | Florida | 33765 | United States |
| Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only) | Crystal River | Florida | 34429 | United States |
| Shands Endoscopy Center | Gainesville | Florida | 32608 | United States |
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610-0214 | United States |
| Investigational Drug Service | Gainesville | Florida | 32610 | United States |
| Shands Medical Plaza and Cancer Center | Gainesville | Florida | 32610 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| Suncoast Endoscopy Center (Colonoscopy Only) | Inverness | Florida | 34453 | United States |
| FQL Research, LLC | Miramar | Florida | 33025 | United States |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | United States |
| Gulfshore Endoscopy Center (Endoscopies Only) | Naples | Florida | 34102 | United States |
| North Florida Gastroenterology Research, LLC | Orange Park | Florida | 32073 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | 33542 | United States |
| Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | 31201 | United States |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | United States |
| Heartland Medical Research, Inc (Administrative Only) | Clive | Iowa | 50325 | United States |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | United States |
| Iowa Endoscopy Center (Colonoscopy Only) | Clive | Iowa | 50325 | United States |
| Iowa Radiology (MRI, X-Ray Only) | Clive | Iowa | 50325 | United States |
| Cotton-O'Neil Clinical (X-Ray) | Topeka | Kansas | 66606 | United States |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | United States |
| Stormont-Vail MRI Center of Kansas | Topeka | Kansas | 66606 | United States |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| Chevy Chase Endoscopy Center | Chevy Chase | Maryland | 20815 | United States |
| Metropolitan Gastroenterology Group, PC | Chevy Chase | Maryland | 20815 | United States |
| East Ann Arbor Health and Geriatrics Center | Ann Arbor | Michigan | 48109-2701 | United States |
| University of Michigan Health Systems | Ann Arbor | Michigan | 48109-5000 | United States |
| Clinical Research Institute of Michigan LLC | Chesterfield | Michigan | 48047 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| NYU Langone Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| NYU Langone Nassau Gastroenterology Associates | Great Neck | New York | 11021 | United States |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York | 12601 | United States |
| Charlotte Gastroenterology and Hepatology, PLLC | Charlotte | North Carolina | 28207 | United States |
| Charlotte Radiology (Chest X-Ray Only) | Charlotte | North Carolina | 28211 | United States |
| University Hospitals Chagrin Highlands Health Center | Beachwood | Ohio | 44122 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Dayton Gastroenterology, Inc. | Dayton | Ohio | 45415 | United States |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | United States |
| The Endoscopy Center of Lake County | Mentor | Ohio | 44060 | United States |
| University Hospitals Westlake Medical Center | Westlake | Ohio | 44145 | United States |
| Great Lakes Gastroenterology | Willoughby | Ohio | 44094 | United States |
| Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania | 17604 | United States |
| UT Health Science Center | Houston | Texas | 77030 | United States |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Cardiology Consultants (ECG Site Only) | Norfolk | Virginia | 23502 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| MRI & CT Diagnostics | Virginia Beach | Virginia | 23455 | United States |
| The Center for Digestive Health | Milwaukee | Wisconsin | 53215 | United States |
| Wisconsin Center for Advanced Research - GI Associates, LLC | Milwaukee | Wisconsin | 53215 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Medical Diagnostic Imaging (MDI) X-ray and MRI only | Milwaukee | Wisconsin | 53222 | United States |
| Allegiance Research Specialists | Wauwatosa | Wisconsin | 53226 | United States |
| GI Associates | Wauwatosa | Wisconsin | 53226 | United States |
| Nepean Public Hospital | Kingswood | New South Wales | 2747 | Australia |
| Monash Medical Center | Clayton | Victoria | 3168 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| AKH Wien Universitaetsklinik fuer Innere Medizin III | Vienna | 1090 | Austria |
| 4-MBAL, Parvo vatreshno otdelenie | Sofia | 1000 | Bulgaria |
| MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia | Sofia | 1431 | Bulgaria |
| MBAL Voennomeditsinska Akademia | Sofia | 1606 | Bulgaria |
| MBAL Sofiamed OOD, Otdelenie po gastroenterologia | Sofia | 1797 | Bulgaria |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Office of Dr. David C. Pearson | Victoria | British Columbia | V8R 6R3 | Canada |
| Office of Drs. Ranjith Andrew Singh and Jamie D. Papp | Victoria | British Columbia | V8V 3P9 | Canada |
| PerCuro Clinical Research Ltd. | Victoria | British Columbia | V8V 3P9 | Canada |
| London Health Sciences Centre - University Hospital | London | Ontario | N6A 5A5 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Montreal General Hospital - McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada |
| Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre | Montreal | Quebec | H3G1A4 | Canada |
| University Hospital Centre Rijeka | Rijeka | 51000 | Croatia |
| University Hospital Center Zagreb | Zagreb | 10000 | Croatia |
| Medial Pharma spol.s.r.o. | Hradec Králové | 500 12 | Czechia |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | 50012 | Czechia |
| RDG centrum s.r.o. | Hradec Králové | 50012 | Czechia |
| Hopital Huriez, CHRU de Lille | Lille | 59037 | France |
| Hopital Haut-Leveque | Pessac | 33064 | France |
| Hopital Robert Debre | Reims | 51092 | France |
| Charite - Campus Berlin Mitte | Berlin | 10117 | Germany |
| Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Universitaetsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I | Ulm | 89081 | Germany |
| General Hospital of Athens "Evangelismos",1st Gastroenterology Department | Kolonaki Athens | 106 76 | Greece |
| Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly | Budapest | 1062 | Hungary |
| Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat | Budapest | 1076 | Hungary |
| Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia | Budapest | 1125 | Hungary |
| Pannonia Maganorvosi Centrum Kft | Budapest | 1136 | Hungary |
| Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium | Budapest | H-1044 | Hungary |
| Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft | Gyöngyös | 3200 | Hungary |
| Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly | Kaposvár | 7400 | Hungary |
| Clinfan Kft. | Szekszárd | 7100 | Hungary |
| Digestive Diseases Institute, Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Dept. of Gastroenterology & Hepatology, Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | 49100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Fukuoka University Chikushi Hospital | Chikushino-shi | Fukuoka | 818-8502 | Japan |
| Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital | Sapporo | Hokkaido | 060-0033 | Japan |
| The Hospital of Hyogo College of Medicine | Nishinomiya | Hyōgo | 663-8501 | Japan |
| National Hospital Organization Sendai Medical Center | Sendai | Miyagi | 983-8520 | Japan |
| Osaka City University Hospital | Osaka | Osaka | 545-8586 | Japan |
| Tokyo Medical And Dental University Hospital, Faculty of Medicine | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Toho University Sakura Medical Center | Chiba | 285-8741 | Japan |
| VU University Medical Center | Amsterdam | 1081 HV | Netherlands |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Kingsbury Hospital | Cape Town | Western Cape | 7708 | South Africa |
| Parklands Medical Centre | Durban | 4091 | South Africa |
| Severance Hospital, Yeonsei University Health System | Seoul | 120-752 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| ASAN Medical Center | Seoul | 138-736 | South Korea |
| Hospital Clinic de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de La Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| State Institution "Institute of Gastroenterology of AMS of Ukraine" | Dnipropetrovsk | 49074 | Ukraine |
| Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2, | Donetsk | 83017 | Ukraine |
| State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine" | Kharkiv | 61039 | Ukraine |
| Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course | Lviv | 79010 | Ukraine |
| Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology. | Odesa | 65117 | Ukraine |
| Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed" | Vinnitsa | 21029 | Ukraine |
| FG002 | Tofacitinib 10 mg BID | Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. |
| FG003 | Tofacitinib 15 mg BID | Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set - included all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks. |
| BG001 | Tofacitinib 5 mg BID | Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks. |
| BG002 | Tofacitinib 10 mg BID | Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. |
| BG003 | Tofacitinib 15 mg BID | Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks. |
| BG004 | 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8 | Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | Full analysis set (FAS) - included all randomized participants who received at least 1 dose of investigational product and who had a qualified CDAI score calculated using the hematocrit value measured at baseline visit (Day 1). Participants with missing values were treated as non-responders. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 8 |
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| Secondary | Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | FAS, participants with missing values were treated as non-responders. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Weeks 2 and 4 |
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| Secondary | Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8 | Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | FAS, participants with missing values were treated as non-responders. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Weeks 2, 4, and 8 |
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| Secondary | Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8 | Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | FAS, participants with missing values were treated as non-responders. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Weeks 2, 4, and 8 |
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| Secondary | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | FAS, participants with missing values were treated as non-responders. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Weeks 2, 4, and 8 |
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| Secondary | CDAI Scores at Weeks 2, 4, and 8 | CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. | FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data. | Posted | Mean | Standard Deviation | Score on a scale | Weeks 2, 4, and 8 |
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| Secondary | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data. | Posted | Mean | Standard Deviation | Milligrams per liter (mg/L) | Weeks 2, 4, and 8 |
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| Secondary | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. | FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data. | Posted | Mean | Standard Deviation | mg per kilogram (mg/kg) | Weeks 2, 4, and 8 |
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| Secondary | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different. | Pharmacokinetic analysis set - included all participants who received at least one dose of study medication and had at least one measurable plasma concentration. n is the number of observations (i.e. non-missing concentrations) at each timepoint. | Posted | Mean | Standard Deviation | nanograms per milliliter | Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit |
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| Secondary | Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit | The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QOL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL. | FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 8/ET visit |
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| Secondary | Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA) | IBDQ is a validated PRO instrument for measuring QOL in IBD consisting of 32 items scored from 1 (worst response) to 7 (best response). 32 items are grouped into 4 domains scored as follows: bowel symptoms 10 - 70; systemic symptoms 5 - 35; emotional function 12 - 84; social function 5 - 35. For each domain, higher score indicates better QOL. Total score is the sum of each item score, & ranged from 32 to 224 with a higher score indicating better QOL. Positive change in total score indicated improvement in QOL. Adjusted means were derived from an ANCOVA model with baseline value as covariate, treatment group & prior use of anti-tumor necrosis factor (TNF) alpha (α) treatments as factors. The 15 mg BID treatment group was closed to further enrolment early in the study by Protocol Amendment 5 after only 16 participants were enrolled in this group. Therefore, the efficacy analysis was not performed for this group as the results may be difficult to interpret due to the small sample size. | FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data. | Posted | Mean | Standard Error | Score on a scale | Baseline, Week 8/ET visit |
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| Secondary | Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit | The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL. | FAS | Posted | Number | Percentage of Participants | Week 8/ET visit |
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| Secondary | Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit | The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL. | FAS. Number of Participants Analyzed is the number of participants in the analysis set. | Posted | Number | Percentage of Participants | Week 8/ET visit |
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| Secondary | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | The IBD Patient Reported Treatment Impact Modified (PRTI) questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to re-use the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment. | FAS. Number of Participants Analyzed is the number of participants in the analysis set. | Posted | Number | Percentage of Participants | Week 8/ET visit |
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| Secondary | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL. | FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 8/ET visit |
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| Secondary | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data. | Posted | Mean | Standard Error | Score on a Scale | Baseline, Week 8/ET visit |
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| Secondary | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from -0.594 to 1.000; a higher score indicates a better health state. | FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 8/ET visit |
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| Secondary | Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA | EQ-5D is a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFα treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data. | Posted | Mean | Standard Error | Score on a Scale | Baseline, Week 8/ET visit |
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| Secondary | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data. | Posted | Mean | Standard Deviation | mm | Baseline, Week 8/ET visit |
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| Secondary | Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA | EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. | FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data. | Posted | Mean | Standard Error | mm | Baseline, Week 8/ET visit |
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SAEs were assessed from informed consent through and including 28 calendar days after last administration of study treatment (i.e. 11 weeks). Non-SAEs were recorded from time of first dose of study treatment through last participant visit (i.e. 15 weeks).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
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 | Placebo | Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks. | 3 | 91 | 43 | 91 | ||
| EG001 | Tofacitinib 5 mg BID | Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks. | 3 | 86 | 37 | 86 | ||
| EG002 | Tofacitinib 10 mg BID | Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. | 10 | 86 | 42 | 86 | ||
| EG003 | Tofacitinib 15 mg BID | Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks. | 0 | 16 | 9 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fistula | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Perirectal abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Pneumonia influenzal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Calculus urethral | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Tenderness | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI must remove any previously undisclosed Confidential Information (other than the Study results themselves) before public release.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
Not provided
Not provided
Not provided
| Male |
|
| 0.3916 |
| Mean Difference (Final Values) |
| 6.36 |
| 2-Sided |
| 95 |
| -8.09 |
| 20.80 |
| Superiority or Other |
| Tofacitinib 10 mg BID |
Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. |
|
|
| OG002 |
| Tofacitinib 10 mg BID |
Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. |
|
|
| OG002 |
| Tofacitinib 10 mg BID |
Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. |
|
|
| OG002 |
| Tofacitinib 10 mg BID |
Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. |
|
|
Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks. |
|
|
|
|
|
|
|
|
| OG002 | Tofacitinib 10 mg BID | Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86). |
| OG003 | Tofacitinib 15 mg BID | Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16). |
|
|
Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85). |
| OG002 | Tofacitinib 10 mg BID | Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86). |
|
|
Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
|
|
Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks. |
|
|
| Tofacitinib 10 mg BID |
Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. |
| OG003 | Tofacitinib 15 mg BID | Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks. |
|
|
Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16). |
|
|
| Tofacitinib 10 mg BID |
Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86). |
|
|
| OG003 | Tofacitinib 15 mg BID | Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16). |
|
|
| OG002 | Tofacitinib 10 mg BID | Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86). |
|
|
Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
|
|
Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86). |
|
|