Crohn's Disease
Conditions
Brief summary
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).
Interventions
DRUGPlacebo
oral tablets twice daily
DRUGCP-690,550
oral tablets twice daily
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands). * Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening. * Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.
Exclusion criteria
* Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC. * Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve). * Subjects receiving the following treatment for Crohn's disease: * Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline. * Anti-TNFα therapy within 8 weeks prior to baseline. * Interferon therapy within 8 weeks prior to baseline. * Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline. * Intravenous corticosteroids within 2 weeks prior to baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 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. |
| 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 | Baseline, 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. |
| Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Baseline, 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. |
| CDAI Scores at Weeks 2, 4, and 8 | 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. |
| C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | 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. |
| Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | 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. |
| Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/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. |
| 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 | Baseline, 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. |
| 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) | Baseline, Week 8/ET visit | 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. |
| Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | 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. |
| Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit | 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. |
| Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | Week 8/ET visit | 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. |
| Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Baseline, 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. |
| Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Baseline, Week 8/ET visit | 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. |
| EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Baseline, 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. |
| Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA | Baseline, Week 8/ET visit | 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. |
| EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | Baseline, 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. |
| Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA | Baseline, 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. 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. |
| Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit | 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. |
Countries
Australia, Austria, Bulgaria, Canada, Croatia, Czechia, France, Germany, Greece, Hungary, Israel, Japan, Netherlands, South Africa, South Korea, Spain, Ukraine, United States
Participant flow
Pre-assignment details
280 participants were randomized to treatment but only 279 participants received treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks. | 91 |
| Tofacitinib 5 mg BID Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks. | 86 |
| Tofacitinib 10 mg BID Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks. | 86 |
| Tofacitinib 15 mg BID Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks. | 16 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 5 | 0 |
| Overall Study | Did not meet entrance criteria | 1 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 6 | 6 | 4 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 |
| Overall Study | Other | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Tofacitinib 15 mg BID | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37.2 Years STANDARD_DEVIATION 11.7 | 40.2 Years STANDARD_DEVIATION 11.5 | 39.3 Years STANDARD_DEVIATION 13.7 | 41.3 Years STANDARD_DEVIATION 14.3 | 39.0 Years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 60 Participants | 32 Participants | 47 Participants | 7 Participants | 146 Participants |
| Sex: Female, Male Male | 31 Participants | 54 Participants | 39 Participants | 9 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 91 | 37 / 86 | 42 / 86 | 9 / 16 |
| serious Total, serious adverse events | 3 / 91 | 3 / 86 | 10 / 86 | 0 / 16 |
Outcome results
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.
Time frame: Week 8
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 | 36.67 Percentage of Participants |
| Tofacitinib 5 mg BID | 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 | 43.53 Percentage of Participants |
| Tofacitinib 10 mg BID | 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 | 43.02 Percentage of Participants |
Comparison: Tofacitinib-Placebop-value: 0.324995% CI: [-7.64, 21.36]Cochran-Mantel-Haenszel
Comparison: Tofacitinib-Placebop-value: 0.391695% CI: [-8.09, 20.8]Cochran-Mantel-Haenszel
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.
Time frame: Weeks 2, 4, and 8
Population: FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 8 (n=75, 66, 72, 14) | 428.45 mg per kilogram (mg/kg) | Standard Deviation 479.36 |
| Placebo | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 4 (n=81, 82, 71, 16) | 493.26 mg per kilogram (mg/kg) | Standard Deviation 682.81 |
| Placebo | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 2 (n=81, 76, 73, 16) | 492.95 mg per kilogram (mg/kg) | Standard Deviation 664.51 |
| Tofacitinib 5 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 8 (n=75, 66, 72, 14) | 417.70 mg per kilogram (mg/kg) | Standard Deviation 336.75 |
| Tofacitinib 5 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 2 (n=81, 76, 73, 16) | 384.81 mg per kilogram (mg/kg) | Standard Deviation 342.9 |
| Tofacitinib 5 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 4 (n=81, 82, 71, 16) | 467.09 mg per kilogram (mg/kg) | Standard Deviation 377.65 |
| Tofacitinib 10 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 4 (n=81, 82, 71, 16) | 359.30 mg per kilogram (mg/kg) | Standard Deviation 306.88 |
| Tofacitinib 10 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 2 (n=81, 76, 73, 16) | 403.35 mg per kilogram (mg/kg) | Standard Deviation 352.57 |
| Tofacitinib 10 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 8 (n=75, 66, 72, 14) | 385.66 mg per kilogram (mg/kg) | Standard Deviation 316.71 |
| Tofacitinib 15 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 8 (n=75, 66, 72, 14) | 349.61 mg per kilogram (mg/kg) | Standard Deviation 365.37 |
| Tofacitinib 15 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 4 (n=81, 82, 71, 16) | 338.11 mg per kilogram (mg/kg) | Standard Deviation 391.65 |
| Tofacitinib 15 mg BID | Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 | Week 2 (n=81, 76, 73, 16) | 455.10 mg per kilogram (mg/kg) | Standard Deviation 461.87 |
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.
Time frame: Weeks 2, 4, and 8
Population: FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | CDAI Scores at Weeks 2, 4, and 8 | Week 8 (n=80, 77, 75, 15) | 194.90 Score on a scale | Standard Deviation 111.88 |
| Placebo | CDAI Scores at Weeks 2, 4, and 8 | Week 2 (n=85, 78, 77, 16) | 258.04 Score on a scale | Standard Deviation 89.79 |
| Placebo | CDAI Scores at Weeks 2, 4, and 8 | Week 4 (n=81, 78, 71, 15) | 228.65 Score on a scale | Standard Deviation 102.01 |
| Tofacitinib 5 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 4 (n=81, 78, 71, 15) | 213.38 Score on a scale | Standard Deviation 86.04 |
| Tofacitinib 5 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 2 (n=85, 78, 77, 16) | 237.60 Score on a scale | Standard Deviation 67.87 |
| Tofacitinib 5 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 8 (n=80, 77, 75, 15) | 162.77 Score on a scale | Standard Deviation 87.67 |
| Tofacitinib 10 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 8 (n=80, 77, 75, 15) | 159.08 Score on a scale | Standard Deviation 81.3 |
| Tofacitinib 10 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 2 (n=85, 78, 77, 16) | 241.21 Score on a scale | Standard Deviation 75.27 |
| Tofacitinib 10 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 4 (n=81, 78, 71, 15) | 203.58 Score on a scale | Standard Deviation 86.69 |
| Tofacitinib 15 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 4 (n=81, 78, 71, 15) | 228.27 Score on a scale | Standard Deviation 103.01 |
| Tofacitinib 15 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 2 (n=85, 78, 77, 16) | 270.31 Score on a scale | Standard Deviation 90.78 |
| Tofacitinib 15 mg BID | CDAI Scores at Weeks 2, 4, and 8 | Week 8 (n=80, 77, 75, 15) | 172.47 Score on a scale | Standard Deviation 119.28 |
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.
Time frame: Baseline, Week 8/ET visit
Population: FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA | 0.08 Score on a Scale | Standard Error 0.029 |
| Tofacitinib 5 mg BID | Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA | 0.14 Score on a Scale | Standard Error 0.03 |
| Tofacitinib 10 mg BID | Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA | 0.16 Score on a Scale | Standard Error 0.03 |
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.
Time frame: Baseline, Week 8/ET visit
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA | 11.97 mm | Standard Error 2.166 |
| Tofacitinib 5 mg BID | Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA | 19.56 mm | Standard Error 2.252 |
| Tofacitinib 10 mg BID | Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA | 20.62 mm | Standard Error 2.222 |
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.
Time frame: Baseline, Week 8/ET visit
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Systemic Symptoms Score | 4.41 Score on a scale | Standard Error 0.66 |
| Placebo | 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) | Social Function Score | 3.68 Score on a scale | Standard Error 0.79 |
| Placebo | 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) | Bowel Function Score | 8.36 Score on a scale | Standard Error 1.23 |
| Placebo | 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) | Emotional Status Score | 10.33 Score on a scale | Standard Error 1.37 |
| Placebo | 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 Total Score | 26.58 Score on a scale | Standard Error 3.76 |
| Tofacitinib 5 mg BID | 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) | Bowel Function Score | 13.76 Score on a scale | Standard Error 1.28 |
| Tofacitinib 5 mg BID | 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) | Systemic Symptoms Score | 6.70 Score on a scale | Standard Error 0.69 |
| Tofacitinib 5 mg BID | 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 Total Score | 41.20 Score on a scale | Standard Error 3.9 |
| Tofacitinib 5 mg BID | 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) | Social Function Score | 7.03 Score on a scale | Standard Error 0.82 |
| Tofacitinib 5 mg BID | 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) | Emotional Status Score | 13.87 Score on a scale | Standard Error 1.42 |
| Tofacitinib 10 mg BID | 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) | Social Function Score | 6.95 Score on a scale | Standard Error 0.82 |
| Tofacitinib 10 mg BID | 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 Total Score | 40.05 Score on a scale | Standard Error 3.9 |
| Tofacitinib 10 mg BID | 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) | Bowel Function Score | 13.88 Score on a scale | Standard Error 1.28 |
| Tofacitinib 10 mg BID | 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) | Emotional Status Score | 12.54 Score on a scale | Standard Error 1.43 |
| Tofacitinib 10 mg BID | 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) | Systemic Symptoms Score | 6.68 Score on a scale | Standard Error 0.69 |
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.
Time frame: Baseline, Week 8/ET visit
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Vitality Domain | 5.55 Score on a Scale | Standard Error 1.19 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Social Functioning Domain | 5.25 Score on a Scale | Standard Error 1.163 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Role Emotional Domain | 5.59 Score on a Scale | Standard Error 1.222 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Mental Health Domain | 6.46 Score on a Scale | Standard Error 1.1 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Role Physical Domain | 5.02 Score on a Scale | Standard Error 1.152 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Mental Component Score | 6.47 Score on a Scale | Standard Error 1.143 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Bodily Pain Domain | 6.41 Score on a Scale | Standard Error 1.132 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | General Health Domain | 3.62 Score on a Scale | Standard Error 0.897 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Physical component score | 3.72 Score on a Scale | Standard Error 0.927 |
| Placebo | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Physical Functioning Domain | 3.01 Score on a Scale | Standard Error 0.85 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Bodily Pain Domain | 9.94 Score on a Scale | Standard Error 1.174 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Role Physical Domain | 8.76 Score on a Scale | Standard Error 1.191 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Social Functioning Domain | 9.72 Score on a Scale | Standard Error 1.206 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Physical Functioning Domain | 6.14 Score on a Scale | Standard Error 0.876 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Mental Component Score | 7.88 Score on a Scale | Standard Error 1.178 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Role Emotional Domain | 7.28 Score on a Scale | Standard Error 1.257 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Vitality Domain | 9.84 Score on a Scale | Standard Error 1.225 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | General Health Domain | 5.55 Score on a Scale | Standard Error 0.937 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Mental Health Domain | 7.05 Score on a Scale | Standard Error 1.136 |
| Tofacitinib 5 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Physical component score | 7.28 Score on a Scale | Standard Error 0.967 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Mental Health Domain | 7.41 Score on a Scale | Standard Error 1.134 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Physical component score | 8.07 Score on a Scale | Standard Error 0.956 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Mental Component Score | 7.13 Score on a Scale | Standard Error 1.18 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Physical Functioning Domain | 5.59 Score on a Scale | Standard Error 0.876 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Role Physical Domain | 8.95 Score on a Scale | Standard Error 1.183 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Bodily Pain Domain | 11.10 Score on a Scale | Standard Error 1.171 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | General Health Domain | 7.03 Score on a Scale | Standard Error 0.933 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Vitality Domain | 8.05 Score on a Scale | Standard Error 1.233 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Social Functioning Domain | 8.66 Score on a Scale | Standard Error 1.204 |
| Tofacitinib 10 mg BID | Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA | Role Emotional Domain | 7.14 Score on a Scale | Standard Error 1.26 |
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.
Time frame: Weeks 2, 4, and 8
Population: FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 2 (n=89, 84, 81, 16) | 17.28 Milligrams per liter (mg/L) | Standard Deviation 23.07 |
| Placebo | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 8 (n=80, 77, 74, 15) | 18.12 Milligrams per liter (mg/L) | Standard Deviation 26.42 |
| Placebo | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 4 (n=83, 82, 78, 16) | 18.94 Milligrams per liter (mg/L) | Standard Deviation 31.26 |
| Tofacitinib 5 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 2 (n=89, 84, 81, 16) | 8.26 Milligrams per liter (mg/L) | Standard Deviation 11.4 |
| Tofacitinib 5 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 8 (n=80, 77, 74, 15) | 9.49 Milligrams per liter (mg/L) | Standard Deviation 15.33 |
| Tofacitinib 5 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 4 (n=83, 82, 78, 16) | 8.17 Milligrams per liter (mg/L) | Standard Deviation 10.6 |
| Tofacitinib 10 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 4 (n=83, 82, 78, 16) | 9.48 Milligrams per liter (mg/L) | Standard Deviation 21.35 |
| Tofacitinib 10 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 2 (n=89, 84, 81, 16) | 8.56 Milligrams per liter (mg/L) | Standard Deviation 14.03 |
| Tofacitinib 10 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 8 (n=80, 77, 74, 15) | 6.55 Milligrams per liter (mg/L) | Standard Deviation 11 |
| Tofacitinib 15 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 2 (n=89, 84, 81, 16) | 7.89 Milligrams per liter (mg/L) | Standard Deviation 9.42 |
| Tofacitinib 15 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 8 (n=80, 77, 74, 15) | 5.77 Milligrams per liter (mg/L) | Standard Deviation 7.74 |
| Tofacitinib 15 mg BID | C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 | Week 4 (n=83, 82, 78, 16) | 10.33 Milligrams per liter (mg/L) | Standard Deviation 16.8 |
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.
Time frame: Baseline, Week 8/ET visit
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | VAS Score, Week 8/ET | 58.32 mm | Standard Deviation 21.31 |
| Placebo | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | VAS Score, Baseline | 46.83 mm | Standard Deviation 18.63 |
| Tofacitinib 5 mg BID | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | VAS Score, Baseline | 49.51 mm | Standard Deviation 18.03 |
| Tofacitinib 5 mg BID | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | VAS Score, Week 8/ET | 67.07 mm | Standard Deviation 19.39 |
| Tofacitinib 10 mg BID | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | VAS Score, Baseline | 42.74 mm | Standard Deviation 18.04 |
| Tofacitinib 10 mg BID | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | VAS Score, Week 8/ET | 65.77 mm | Standard Deviation 19.71 |
| Tofacitinib 15 mg BID | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | VAS Score, Week 8/ET | 69.81 mm | Standard Deviation 21.11 |
| Tofacitinib 15 mg BID | EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit | VAS Score, Baseline | 52.06 mm | Standard Deviation 24.11 |
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.
Time frame: Baseline, Week 8/ET visit
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Utility Score, Baseline | 0.56 Score on a Scale | Standard Deviation 0.29 |
| Placebo | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Utility Score, Week 8/ET | 0.64 Score on a Scale | Standard Deviation 0.27 |
| Tofacitinib 5 mg BID | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Utility Score, Baseline | 0.58 Score on a Scale | Standard Deviation 0.26 |
| Tofacitinib 5 mg BID | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Utility Score, Week 8/ET | 0.71 Score on a Scale | Standard Deviation 0.28 |
| Tofacitinib 10 mg BID | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Utility Score, Week 8/ET | 0.71 Score on a Scale | Standard Deviation 0.27 |
| Tofacitinib 10 mg BID | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Utility Score, Baseline | 0.49 Score on a Scale | Standard Deviation 0.31 |
| Tofacitinib 15 mg BID | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Utility Score, Week 8/ET | 0.77 Score on a Scale | Standard Deviation 0.3 |
| Tofacitinib 15 mg BID | EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit | Utility Score, Baseline | 0.61 Score on a Scale | Standard Deviation 0.24 |
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.
Time frame: Baseline, Week 8/ET visit
Population: FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | IBDQ Total Score, Baseline | 118.50 Score on a scale | Standard Deviation 28.48 |
| Placebo | 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 | IBDQ Total Score, Week 8/ET | 144.99 Score on a scale | Standard Deviation 37.97 |
| Placebo | 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 | Bowel Function Score, Baseline | 37.78 Score on a scale | Standard Deviation 8.17 |
| Placebo | 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 | Bowel Function Score, Week 8/ET | 45.76 Score on a scale | Standard Deviation 12.19 |
| Placebo | 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 | Emotional Status Score, Baseline | 45.88 Score on a scale | Standard Deviation 13.04 |
| Placebo | 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 | Emotional Status Score, Week 8/ET | 56.31 Score on a scale | Standard Deviation 14.39 |
| Placebo | 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 | Systemic Symptoms Score, Baseline | 15.22 Score on a scale | Standard Deviation 5.24 |
| Placebo | 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 | Systemic Symptoms Score, Week 8/ET | 19.70 Score on a scale | Standard Deviation 6.51 |
| Placebo | 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 | Social Function Score, Baseline | 19.62 Score on a scale | Standard Deviation 7.28 |
| Placebo | 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 | Social Function Score, Week 8/ET | 23.23 Score on a scale | Standard Deviation 8.47 |
| Tofacitinib 5 mg BID | 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 | Bowel Function Score, Baseline | 37.39 Score on a scale | Standard Deviation 9.37 |
| Tofacitinib 5 mg BID | 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 | Social Function Score, Baseline | 19.48 Score on a scale | Standard Deviation 6.62 |
| Tofacitinib 5 mg BID | 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 | Bowel Function Score, Week 8/ET | 50.94 Score on a scale | Standard Deviation 11.02 |
| Tofacitinib 5 mg BID | 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 | Emotional Status Score, Baseline | 45.34 Score on a scale | Standard Deviation 13.27 |
| Tofacitinib 5 mg BID | 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 | Emotional Status Score, Week 8/ET | 59.54 Score on a scale | Standard Deviation 13.78 |
| Tofacitinib 5 mg BID | 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 | Systemic Symptoms Score, Baseline | 15.58 Score on a scale | Standard Deviation 4.36 |
| Tofacitinib 5 mg BID | 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 | Social Function Score, Week 8/ET | 26.43 Score on a scale | Standard Deviation 7.57 |
| Tofacitinib 5 mg BID | 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 | Systemic Symptoms Score, Week 8/ET | 22.24 Score on a scale | Standard Deviation 6.3 |
| Tofacitinib 5 mg BID | 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 | IBDQ Total Score, Baseline | 117.89 Score on a scale | Standard Deviation 27.98 |
| Tofacitinib 5 mg BID | 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 | IBDQ Total Score, Week 8/ET | 159.14 Score on a scale | Standard Deviation 35.39 |
| Tofacitinib 10 mg BID | 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 | Systemic Symptoms Score, Week 8/ET | 21.80 Score on a scale | Standard Deviation 6.27 |
| Tofacitinib 10 mg BID | 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 | Systemic Symptoms Score, Baseline | 14.60 Score on a scale | Standard Deviation 4.78 |
| Tofacitinib 10 mg BID | 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 | Social Function Score, Week 8/ET | 25.83 Score on a scale | Standard Deviation 7.8 |
| Tofacitinib 10 mg BID | 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 | IBDQ Total Score, Baseline | 113.67 Score on a scale | Standard Deviation 28.45 |
| Tofacitinib 10 mg BID | 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 | Bowel Function Score, Week 8/ET | 50.69 Score on a scale | Standard Deviation 11.02 |
| Tofacitinib 10 mg BID | 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 | Emotional Status Score, Week 8/ET | 58.32 Score on a scale | Standard Deviation 14.71 |
| Tofacitinib 10 mg BID | 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 | Social Function Score, Baseline | 18.23 Score on a scale | Standard Deviation 7.09 |
| Tofacitinib 10 mg BID | 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 | IBDQ Total Score, Week 8/ET | 156.64 Score on a scale | Standard Deviation 36.66 |
| Tofacitinib 10 mg BID | 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 | Emotional Status Score, Baseline | 44.55 Score on a scale | Standard Deviation 13.27 |
| Tofacitinib 10 mg BID | 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 | Bowel Function Score, Baseline | 36.29 Score on a scale | Standard Deviation 7.72 |
| Tofacitinib 15 mg BID | 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 | Emotional Status Score, Baseline | 47.25 Score on a scale | Standard Deviation 10.41 |
| Tofacitinib 15 mg BID | 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 | Systemic Symptoms Score, Week 8/ET | 22.88 Score on a scale | Standard Deviation 7.05 |
| Tofacitinib 15 mg BID | 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 | Emotional Status Score, Week 8/ET | 57.25 Score on a scale | Standard Deviation 20.07 |
| Tofacitinib 15 mg BID | 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 | Social Function Score, Week 8/ET | 26.38 Score on a scale | Standard Deviation 9.58 |
| Tofacitinib 15 mg BID | 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 | Systemic Symptoms Score, Baseline | 16.44 Score on a scale | Standard Deviation 5.35 |
| Tofacitinib 15 mg BID | 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 | IBDQ Total Score, Week 8/ET | 159.00 Score on a scale | Standard Deviation 47.98 |
| Tofacitinib 15 mg BID | 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 | Bowel Function Score, Baseline | 37.50 Score on a scale | Standard Deviation 9.78 |
| Tofacitinib 15 mg BID | 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 | Bowel Function Score, Week 8/ET | 52.50 Score on a scale | Standard Deviation 13.81 |
| Tofacitinib 15 mg BID | 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 | IBDQ Total Score, Baseline | 124.19 Score on a scale | Standard Deviation 26.97 |
| Tofacitinib 15 mg BID | 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 | Social Function Score, Baseline | 23.00 Score on a scale | Standard Deviation 6.29 |
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.
Time frame: Baseline, Weeks 2, 4, and 8
Population: FAS, participants with missing values were treated as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | Week 8 | 54.44 Percentage of Participants |
| Placebo | 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 | Week 4 | 37.78 Percentage of Participants |
| Placebo | 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 | Week 2 | 23.33 Percentage of Participants |
| Tofacitinib 5 mg BID | 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 | Week 8 | 70.59 Percentage of Participants |
| Tofacitinib 5 mg BID | 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 | Week 2 | 34.12 Percentage of Participants |
| Tofacitinib 5 mg BID | 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 | Week 4 | 48.24 Percentage of Participants |
| Tofacitinib 10 mg BID | 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 | Week 8 | 68.60 Percentage of Participants |
| Tofacitinib 10 mg BID | 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 | Week 4 | 45.35 Percentage of Participants |
| Tofacitinib 10 mg BID | 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 | Week 2 | 32.56 Percentage of Participants |
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.
Time frame: Baseline, Weeks 2, 4, and 8
Population: FAS, participants with missing values were treated as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | Week 4 | 50.00 Percentage of Participants |
| Placebo | 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 | Week 2 | 37.78 Percentage of Participants |
| Placebo | 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 | Week 8 | 62.22 Percentage of Participants |
| Tofacitinib 5 mg BID | 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 | Week 4 | 57.65 Percentage of Participants |
| Tofacitinib 5 mg BID | 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 | Week 2 | 47.06 Percentage of Participants |
| Tofacitinib 5 mg BID | 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 | Week 8 | 76.47 Percentage of Participants |
| Tofacitinib 10 mg BID | 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 | Week 2 | 44.19 Percentage of Participants |
| Tofacitinib 10 mg BID | 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 | Week 8 | 74.42 Percentage of Participants |
| Tofacitinib 10 mg BID | 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 | Week 4 | 56.98 Percentage of Participants |
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.
Time frame: Baseline, Weeks 2, 4, and 8
Population: FAS, participants with missing values were treated as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 4 | 38.89 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 2 | 24.44 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 8 | 55.56 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 4 | 49.41 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 2 | 34.12 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 8 | 71.76 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 2 | 32.56 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 8 | 69.77 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 | Week 4 | 46.51 Percentage of Participants |
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.
Time frame: Weeks 2 and 4
Population: FAS, participants with missing values were treated as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | Week 2 | 10.00 Percentage of Participants |
| Placebo | Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | Week 4 | 21.11 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | Week 2 | 9.41 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | Week 4 | 24.71 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | Week 2 | 9.30 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 | Week 4 | 22.09 Percentage of Participants |
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.
Time frame: Week 8/ET visit
Population: FAS. Number of Participants Analyzed is the number of participants in the analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit | 61.4 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit | 75.0 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit | 76.5 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit | 75.0 Percentage of Participants |
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.
Time frame: Week 8/ET visit
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit | 26.1 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit | 45.2 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit | 43.2 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit | 43.8 Percentage of Participants |
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.
Time frame: Week 8/ET visit
Population: FAS. Number of Participants Analyzed is the number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Injectable prescription medicines | 42.0 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Definitely not want to use same drug again | 17.0 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Would definitely want to use same drug again | 44.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Satisfied | 40.9 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Neither satisfied nor dissatisfied | 25.0 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Extremely dissatisfied | 17.0 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Slight preference for previous treatment | 9.1 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Dissatisfied | 10.2 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: I have no preference either way | 28.4 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Might want to use the same drug again | 11.4 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: No, I definitely prefer my previous treatment | 10.2 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Slight preference for drug I'm receiving now | 19.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Definitely prefer the drug I am receiving now | 33.0 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: I am not sure | 20.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Extremely satisfied | 6.8 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: No treatment | 12.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Surgery | 2.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Might not want to use same drug again | 6.8 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA:Prescription medicines and surgery | 5.7 Percentage of Participants |
| Placebo | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Prescription medicines taken by mouth | 37.5 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Dissatisfied | 9.6 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Surgery | 2.5 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Would definitely want to use same drug again | 53.0 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Might want to use the same drug again | 24.1 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: I am not sure | 10.8 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Might not want to use same drug again | 2.4 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Definitely not want to use same drug again | 9.6 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Extremely dissatisfied | 6.0 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Neither satisfied nor dissatisfied | 19.3 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Satisfied | 45.8 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Extremely satisfied | 19.3 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Injectable prescription medicines | 39.5 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Prescription medicines taken by mouth | 44.4 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA:Prescription medicines and surgery | 7.4 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: No treatment | 6.2 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Definitely prefer the drug I am receiving now | 42.2 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Slight preference for drug I'm receiving now | 27.7 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: I have no preference either way | 19.3 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Slight preference for previous treatment | 2.4 Percentage of Participants |
| Tofacitinib 5 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: No, I definitely prefer my previous treatment | 8.4 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Might not want to use same drug again | 4.9 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Definitely prefer the drug I am receiving now | 48.1 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Slight preference for previous treatment | 7.4 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Might want to use the same drug again | 17.3 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Injectable prescription medicines | 22.2 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Slight preference for drug I'm receiving now | 22.2 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA:Prescription medicines and surgery | 8.6 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Would definitely want to use same drug again | 61.7 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: I am not sure | 8.6 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Extremely dissatisfied | 7.4 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Prescription medicines taken by mouth | 56.8 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Dissatisfied | 6.2 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: No treatment | 12.3 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Extremely satisfied | 27.2 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: No, I definitely prefer my previous treatment | 8.6 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Neither satisfied nor dissatisfied | 16.0 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Surgery | 0 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Definitely not want to use same drug again | 7.4 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: I have no preference either way | 13.6 Percentage of Participants |
| Tofacitinib 10 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Satisfied | 43.2 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Prescription medicines taken by mouth | 43.8 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Extremely satisfied | 43.8 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Might not want to use same drug again | 0 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Injectable prescription medicines | 37.5 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: No, I definitely prefer my previous treatment | 0 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: I am not sure | 6.3 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: Surgery | 0 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA:Prescription medicines and surgery | 6.3 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Slight preference for previous treatment | 0 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPTA: No treatment | 12.5 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Might want to use the same drug again | 37.5 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: I have no preference either way | 18.8 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Definitely prefer the drug I am receiving now | 56.3 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PPA: Slight preference for drug I'm receiving now | 25.0 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Would definitely want to use same drug again | 50.0 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Extremely dissatisfied | 6.3 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Satisfied | 25.0 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Dissatisfied | 0 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PWA: Definitely not want to use same drug again | 6.3 Percentage of Participants |
| Tofacitinib 15 mg BID | Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category | PSA: Neither satisfied nor dissatisfied | 25.0 Percentage of Participants |
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.
Time frame: Baseline, Week 8/ET visit
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Emotional Domain, Week 8/ET | 43.06 Score on a Scale | Standard Deviation 12.43 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Component Score, Baseline | 36.50 Score on a Scale | Standard Deviation 12.26 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Health Domain, Baseline | 37.60 Score on a Scale | Standard Deviation 12.3 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | General Health Domain, Baseline | 30.58 Score on a Scale | Standard Deviation 7.21 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical component score, Baseline | 37.12 Score on a Scale | Standard Deviation 7.66 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Component Score, Week 8/ET | 42.46 Score on a Scale | Standard Deviation 11.21 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | General Health Domain, Week 8/ET | 34.36 Score on a Scale | Standard Deviation 8.5 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Social Functioning Domain, Week 8/ET | 40.02 Score on a Scale | Standard Deviation 12.33 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Social Functioning Domain, Baseline | 34.71 Score on a Scale | Standard Deviation 11.83 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical Functioning Domain, Baseline | 43.73 Score on a Scale | Standard Deviation 8.93 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Bodily Pain Domain, Baseline | 34.69 Score on a Scale | Standard Deviation 8.79 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Bodily Pain Domain, Week 8/ET | 40.81 Score on a Scale | Standard Deviation 10.43 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Vitality Domain, Week 8/ET | 41.20 Score on a Scale | Standard Deviation 11.45 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical Functioning Domain, Week 8/ET | 46.55 Score on a Scale | Standard Deviation 8.93 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical component score, Week 8/ET | 40.84 Score on a Scale | Standard Deviation 9.23 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Emotional Domain, Baseline | 38.45 Score on a Scale | Standard Deviation 13.98 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Vitality Domain, Baseline | 35.06 Score on a Scale | Standard Deviation 9.7 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Physical Domain, Baseline | 35.34 Score on a Scale | Standard Deviation 9.94 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Physical Domain, Week 8/ET | 39.92 Score on a Scale | Standard Deviation 10.64 |
| Placebo | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Health Domain, Week 8/ET | 43.75 Score on a Scale | Standard Deviation 11.02 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Emotional Domain, Baseline | 37.20 Score on a Scale | Standard Deviation 12.96 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Physical Domain, Week 8/ET | 44.49 Score on a Scale | Standard Deviation 11.52 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Health Domain, Week 8/ET | 43.58 Score on a Scale | Standard Deviation 11.67 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Bodily Pain Domain, Baseline | 35.22 Score on a Scale | Standard Deviation 8.44 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Vitality Domain, Week 8/ET | 45.22 Score on a Scale | Standard Deviation 11.94 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | General Health Domain, Baseline | 31.37 Score on a Scale | Standard Deviation 7.15 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Bodily Pain Domain, Week 8/ET | 44.68 Score on a Scale | Standard Deviation 11.29 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical component score, Baseline | 38.49 Score on a Scale | Standard Deviation 6.78 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Vitality Domain, Baseline | 34.66 Score on a Scale | Standard Deviation 7.86 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Emotional Domain, Week 8/ET | 44.77 Score on a Scale | Standard Deviation 12.46 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical component score, Week 8/ET | 45.23 Score on a Scale | Standard Deviation 8.85 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Component Score, Baseline | 34.85 Score on a Scale | Standard Deviation 11.68 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Health Domain, Baseline | 35.95 Score on a Scale | Standard Deviation 11.38 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Social Functioning Domain, Baseline | 35.53 Score on a Scale | Standard Deviation 11.69 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Component Score, Week 8/ET | 43.69 Score on a Scale | Standard Deviation 12.15 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical Functioning Domain, Baseline | 43.56 Score on a Scale | Standard Deviation 8.81 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Social Functioning Domain, Week 8/ET | 45.01 Score on a Scale | Standard Deviation 11.79 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical Functioning Domain, Week 8/ET | 49.68 Score on a Scale | Standard Deviation 8.43 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Physical Domain, Baseline | 36.36 Score on a Scale | Standard Deviation 9.71 |
| Tofacitinib 5 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | General Health Domain, Week 8/ET | 36.79 Score on a Scale | Standard Deviation 8.53 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Emotional Domain, Baseline | 35.34 Score on a Scale | Standard Deviation 13.23 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Vitality Domain, Week 8/ET | 44.60 Score on a Scale | Standard Deviation 12.53 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Health Domain, Week 8/ET | 44.76 Score on a Scale | Standard Deviation 11.64 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical component score, Baseline | 35.28 Score on a Scale | Standard Deviation 8.49 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical component score, Week 8/ET | 44.29 Score on a Scale | Standard Deviation 9.41 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Component Score, Baseline | 35.84 Score on a Scale | Standard Deviation 10.68 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Component Score, Week 8/ET | 43.65 Score on a Scale | Standard Deviation 11.87 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical Functioning Domain, Baseline | 41.36 Score on a Scale | Standard Deviation 10.03 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical Functioning Domain, Week 8/ET | 48.37 Score on a Scale | Standard Deviation 8.78 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Physical Domain, Baseline | 32.57 Score on a Scale | Standard Deviation 10.92 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Physical Domain, Week 8/ET | 42.84 Score on a Scale | Standard Deviation 11.59 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Bodily Pain Domain, Baseline | 33.32 Score on a Scale | Standard Deviation 8.25 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Bodily Pain Domain, Week 8/ET | 45.10 Score on a Scale | Standard Deviation 10.41 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | General Health Domain, Week 8/ET | 37.19 Score on a Scale | Standard Deviation 10.75 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Vitality Domain, Baseline | 35.80 Score on a Scale | Standard Deviation 9.05 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Social Functioning Domain, Baseline | 33.83 Score on a Scale | Standard Deviation 11.36 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Social Functioning Domain, Week 8/ET | 43.46 Score on a Scale | Standard Deviation 11.43 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | General Health Domain, Baseline | 29.56 Score on a Scale | Standard Deviation 7.52 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Emotional Domain, Week 8/ET | 43.76 Score on a Scale | Standard Deviation 11.94 |
| Tofacitinib 10 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Health Domain, Baseline | 36.98 Score on a Scale | Standard Deviation 11.09 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical Functioning Domain, Week 8/ET | 49.57 Score on a Scale | Standard Deviation 8.99 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Emotional Domain, Week 8/ET | 42.90 Score on a Scale | Standard Deviation 16.58 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Vitality Domain, Baseline | 37.55 Score on a Scale | Standard Deviation 11.88 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical Functioning Domain, Baseline | 42.66 Score on a Scale | Standard Deviation 9.04 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Component Score, Week 8/ET | 42.73 Score on a Scale | Standard Deviation 16.37 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Component Score, Baseline | 39.26 Score on a Scale | Standard Deviation 11.85 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Health Domain, Week 8/ET | 43.00 Score on a Scale | Standard Deviation 15.96 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Social Functioning Domain, Baseline | 35.90 Score on a Scale | Standard Deviation 10.61 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Social Functioning Domain, Week 8/ET | 43.63 Score on a Scale | Standard Deviation 14.94 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Vitality Domain, Week 8/ET | 48.77 Score on a Scale | Standard Deviation 13.41 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Emotional Domain, Baseline | 39.12 Score on a Scale | Standard Deviation 14.02 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical component score, Week 8/ET | 47.01 Score on a Scale | Standard Deviation 7.97 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Physical component score, Baseline | 37.09 Score on a Scale | Standard Deviation 9.14 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Bodily Pain Domain, Week 8/ET | 47.61 Score on a Scale | Standard Deviation 11.21 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Bodily Pain Domain, Baseline | 34.98 Score on a Scale | Standard Deviation 8.23 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | General Health Domain, Baseline | 32.08 Score on a Scale | Standard Deviation 12.42 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Physical Domain, Week 8/ET | 44.39 Score on a Scale | Standard Deviation 13.18 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Role Physical Domain, Baseline | 37.68 Score on a Scale | Standard Deviation 12.43 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | Mental Health Domain, Baseline | 41.27 Score on a Scale | Standard Deviation 10.27 |
| Tofacitinib 15 mg BID | Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit | General Health Domain, Week 8/ET | 37.98 Score on a Scale | Standard Deviation 13.51 |
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.
Time frame: Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 40 minutes (n=82, 81, 16) | 41.03 nanograms per milliliter | Standard Deviation 24.21 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 40 minutes (n=70, 69, 12) | 37.75 nanograms per milliliter | Standard Deviation 23.891 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 1 hour (n=70, 69, 12) | 37.47 nanograms per milliliter | Standard Deviation 21.384 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 2 hours (n=72, 70, 13) | 27.61 nanograms per milliliter | Standard Deviation 15.742 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 20 minutes (n=82, 83, 16) | 27.44 nanograms per milliliter | Standard Deviation 27.335 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 1 hour (n=83, 83, 16) | 41.22 nanograms per milliliter | Standard Deviation 18.432 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 0 hours (n=78, 72, 13) | 4.216 nanograms per milliliter | Standard Deviation 7.1089 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 2 hours (n=83, 82, 16) | 31.85 nanograms per milliliter | Standard Deviation 12.442 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 0 hours (n=83, 83, 16) | 0.006687 nanograms per milliliter | Standard Deviation 0.049144 |
| Placebo | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 20 minutes (n=70, 70, 12) | 25.89 nanograms per milliliter | Standard Deviation 21.485 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 20 minutes (n=82, 83, 16) | 62.28 nanograms per milliliter | Standard Deviation 60.795 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 1 hour (n=83, 83, 16) | 82.48 nanograms per milliliter | Standard Deviation 40.782 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 40 minutes (n=70, 69, 12) | 93.09 nanograms per milliliter | Standard Deviation 46.471 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 40 minutes (n=82, 81, 16) | 84.61 nanograms per milliliter | Standard Deviation 47.47 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 0 hours (n=78, 72, 13) | 11.57 nanograms per milliliter | Standard Deviation 21.453 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 1 hour (n=70, 69, 12) | 83.14 nanograms per milliliter | Standard Deviation 35.1 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 0 hours (n=83, 83, 16) | 1.193 nanograms per milliliter | Standard Deviation 9.0312 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 20 minutes (n=70, 70, 12) | 71.14 nanograms per milliliter | Standard Deviation 54.969 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 2 hours (n=72, 70, 13) | 62.38 nanograms per milliliter | Standard Deviation 27.505 |
| Tofacitinib 5 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 2 hours (n=83, 82, 16) | 70.01 nanograms per milliliter | Standard Deviation 24.838 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 2 hours (n=72, 70, 13) | 92.03 nanograms per milliliter | Standard Deviation 27.806 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 0 hours (n=83, 83, 16) | NA nanograms per milliliter | — |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 20 minutes (n=82, 83, 16) | 65.83 nanograms per milliliter | Standard Deviation 63.232 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 40 minutes (n=82, 81, 16) | 151.4 nanograms per milliliter | Standard Deviation 61.288 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 1 hour (n=83, 83, 16) | 149.9 nanograms per milliliter | Standard Deviation 42.22 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Day 1, 2 hours (n=83, 82, 16) | 106.1 nanograms per milliliter | Standard Deviation 26.661 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 0 hours (n=78, 72, 13) | 23.89 nanograms per milliliter | Standard Deviation 45.837 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 20 minutes (n=70, 70, 12) | 127.6 nanograms per milliliter | Standard Deviation 89.861 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 40 minutes (n=70, 69, 12) | 148.7 nanograms per milliliter | Standard Deviation 58.948 |
| Tofacitinib 10 mg BID | Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit | Week 8/ET, 1 hour (n=70, 69, 12) | 144.7 nanograms per milliliter | Standard Deviation 48.137 |