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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002345-23 | EudraCT Number |
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This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Active Comparator | Treatment Arm 1 will also receive standard of care medications |
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| Treatment Arm 2 | Experimental | Treatment Arm 2 will also receive standard of care medications |
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| Treatment Arm 3 | Experimental | Treatment Arm 3 will also receive standard of care medications |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | Standard of care |
| |
| CP-690,550 |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit | Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Percentage of Participants With Malignancies | All treatment-emergent malignancies in Study A3921050 were included as collected on the Malignancy Case Report Form page. | Months 12 through 72. |
| Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min]) | Glomerular filtration rate (GFR): an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous (IV) bolus over 5 minutes immediately after morning dosing of Tofacitinib or CsA on day of GFR evaluation. Blood samples for iohexol (3 millilitres [mL] each to provide a minimum of 1 mL serum) were collected into appropriately labeled tubes containing no additives at 120, 180, 240, and 300 minutes after the end of the iohexol IV bolus. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure. | Month 36 |
| Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36 | Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]). The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 36 Banff-CS greater than the implantation biopsy score indicated progression of lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Efficacy failure was the first occurrence of BPAR diagnosed by the central pathologist or graft loss including participant death. BPAR (category acute rejection) was interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Cedars-Sinai MedicalCenter |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants who had completed 12 months treatment with tofacitinib or cyclosporine (CsA) in previous parent study (A3921030) continued study drugs for an additional 60 months in this extension study.
Participants were recruited and studied between 18 August 2008 and 18 February 2015. Those with 6-month time-weighted concentrations at 2-hours postdose (TWC2) above the median (Amendment 3), negative/unknown Epstein-Barr virus (EBV) at transplant, cytomegalovirus disease or lymphocyte-depleting agents posttransplant (Amendment 4) were discontinued
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine | CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
CP-690,550 tablets dosed BID Months 12-72 |
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| CP-690,550 | Drug | CP-690,550 tablets dosed BID Months 12-72 |
|
| Month 36 |
| Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | BPAR was category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit | Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit | Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection was calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit | Graft loss was defined as graft nephrectomy, subject death, retransplantation, or return to dialysis for at least 6 consecutive weeks. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit. | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit. | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Percentage of Participants Discontinuing From the Study | Discontinuations were due to any reason including those occurring as a result of protocol Amendments 3 and 4. | Months 12 through 72. |
| Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit | Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals. | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up |
| Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit | Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals. | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up |
| Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes. | Months 24, 36, 48, 60, 72 |
| Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A compund symmetry variance-covariance structure was used. | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Percentage of Participants by Proteinuria Category by Visit | Proteinuria was defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals. | Months 24, 36, 48, 60, 72 and Follow-up |
| Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Nankivell formula, where: Creatinine clearance (mL/min) = 6.7/serum creatinine (millimols per litre [mmol/L]) - serum urea (mmol/dL)/2 + actual body weight (kilograms [kg])/4 - 100/Height (metres [m])^2 + (35 for male or 25 for female). A normal GFR for adults is > 90 mL/min. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used. | Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR (mL/min) was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used. | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR (mL/min/1.73 m^2) by MDRD equation = 170 * (serum creatinine [mg/dL])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration [mg/dL])^(-0.170) * (serum albumin concentration [g/dL])^(0.318). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used. | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
| Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36 | SF-36 v2 is a self-administered 36-item generic health status measure with 8 general health concepts which are the weighted sums of the questions in their section: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each scale is transformed into a 0 (minimum) to 100 (maximum) scale on the assumption each question carries equal weight. These concepts were also summarized into 2 summary scores; Physical Component Summary and Mental Component Summary (both a 0-100 scale). The 8 subscales, 2 summary scores and transition Question 2 (TR Scale, measured on a scale of 1 [minimum] to 5 [maximum]) were subjected to analysis. Higher domain, summary scores, and TR scale scores indicate better health status. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. First-order autoregressive variance-covariance structure was used. | Months 24, 36 |
| Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36 | ESRD-SCL: a 43-item disease specific self-administered questionnaire. Participants' rated the question "At the moment,how much do you suffer?" for each item on a 5 point scale, range (Ra) from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: Cardiac and Renal (CR) dysfunction; Ra 0 to 28, Increased(In) Growth of Gum and Hair (IGGH); Ra 0 to 20, Limited Cognitive Capacity (LCC); Ra 0 to 32, Limited Physical Capacity (LPC); Ra 0 to 40, Side Effects (SEs) of Corticosteroids; Ra 0 to 20, Transplantation Associated Psychological Distress (TAPD); Ra 0 to 32. Total Score: 0 to 172, higher scores indicate greater dysfunction. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Months 24, 36 |
| Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36 | SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia; consists of 3 subscales: Pain Intensity (PI, 6-items to assess pain and intensity of abdominal discomfort; Range: 2 to 47, higher score indicates greater pain and abdominal discomfort), Non-Pain Symptoms (NPS, 7-items to assess severity and impact of non-pain symptoms: burping/belching, heartburn, bloating, flatulence, sour taste, nausea, and bad breath; Range: 7 to 35, higher scores indicate increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with abdominal discomfort; Range: 2 to 23, higher scores indicate more satisfaction). Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Months 24, 36 |
| Mean Trough Levels of Tofacitinib by Visit | The dates and times were recorded for the 6 doses of tofacitinib administered before each scheduled pharmacokinetic (PK) sampling. The participant was instructed to follow a 12 hourly schedule for these 6 doses of tofacitinib, with each dose administered within 1 hour of the scheduled time. Trough samples were collected 0 to 10 minutes prior to the morning dose. 1 hour postdose samples were required within 10 minutes of the nominal time point. Samples taken at -2 hours predose and at time points >1 hour post dose were required within 30 minutes of the nominal time point. | Months 18 and 24 (-2 hours, predose, 1 hour, 2 hours), Month 30 (predose, 1 hour and 2 hours), Month 36 (predose, 1, 2, and 4 hours), Months 42, 48, 54, 60, 66, 72 (predose and 2 hours) |
| Mean Trough Levels of Cyclosporine by Visit | All CsA samples were taken predose (collected 0 to 10 minutes prior to the morning dose). | Predose: Months 18, 24, 36, 48, 60, 72 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Stanford School of Medicine | Palo Alto | California | 94304 | United States |
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| Balboa Institute of Transplantation | San Diego | California | 92123 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| California Pacific Medical Center - Pacific Campus | San Francisco | California | 94115 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| UCSF Medical Center - Long Hospital | San Francisco | California | 94143 | United States |
| USCF Medical Center - Connie Frank Transplant Center | San Francisco | California | 94143 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Yale-New Haven Hospital | New Haven | Connecticut | 06504 | United States |
| Yale Physicians Building | New Haven | Connecticut | 06510 | United States |
| University Of Florida | Gainesville | Florida | 32610 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| NUCATS's Clinical Research Unit | Chicago | Illinois | 60611 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Investigational Drug Services (IDS) / UNC Healthcare | Chapel Hill | North Carolina | 27514 | United States |
| Transplant Clinic/UNC Heathcare | Chapel Hill | North Carolina | 27514 | United States |
| UNC Department of Surgery, Clinical Trials Consortium | Chapel Hill | North Carolina | 27599-7211 | United States |
| UNC Department of Surgery/Abdominal Transplant Division | Chapel Hill | North Carolina | 27599-7211 | United States |
| Division of Pharmacotherapy, School of Pharmacy, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7360 | United States |
| University of North Carolina, Department of Medicine/Nephrology | Chapel Hill | North Carolina | 27599 | United States |
| Drexel University College of Medicine - Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | United States |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | United States |
| Medical University of South Carolina, Department of Transplantation Surgery | Charleston | South Carolina | 29425 | United States |
| Nephrology Clinic | Charleston | South Carolina | 29425 | United States |
| Dallas Transplant Institute | Dallas | Texas | 75204 | United States |
| Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Westmead Hospital, Department of Renal Medicine | Westmead | New South Wales | 2145 | Australia |
| Central Northern Adelaide Renal and Transplantation Service | Adelaide | South Australia | 5000 | Australia |
| The Queen Elizabeth Hospital | Woodville | South Australia | 5011 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Hopital Erasme | Anderlecht | Brussels Capital | 1070 | Belgium |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital do Rim e Hipertensao | São Paulo | São Paulo | 04038-002 | Brazil |
| Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao | São Paulo | São Paulo | 04039-033 | Brazil |
| Hospital do Rim e Hipertensao | São Paulo | 04038-002 | Brazil |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Institut Klinicke a Experimentalni Mediciny | Praha 4 Krc | 140 21 | Czechia |
| Hopital Necker | Paris | 75743 | France |
| CHRU de Nancy-Brabois - Service de Nephrologie | Vandœuvre-lès-Nancy | 54500 | France |
| Charite - Universitatsmedizin Berlin | Berlin | 10117 | Germany |
| Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore | Roma | RM | 00168 | Italy |
| Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi | Bologna | 40138 | Italy |
| Erasmus Medisch Centrum | Rotterdam | 3015 GD | Netherlands |
| Oslo universitetssykehus HF- Rikshospitalet | Oslo | 0372 | Norway |
| Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu | Wroclaw | 50-556 | Poland |
| Hospitais da Universidade de Coimbra, EPE | Coimbra | 3000-075 | Portugal |
| Hospital Curry Cabral | Lisbon | 1069-166 | Portugal |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Department of Surgery, Yonsei University College of Medicine Severance Hospital | Seoul | 120-752 | South Korea |
| Asan Medical Center, Department of Surgery | Seoul | 138-736 | South Korea |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| FG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| FG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set was defined as those participants who received at least 1 dose of study drug in Study A3921050.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine | CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| BG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| BG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit | Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | Safety Analysis Set. n is the number of participants remaining at risk at each visit. | Posted | Number | 60% Confidence Interval | Percentage of Participants | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Primary | Percentage of Participants With Malignancies | All treatment-emergent malignancies in Study A3921050 were included as collected on the Malignancy Case Report Form page. | Safety Analysis Set. Percentages use n (the number of participants with malignancies: 7,8,8 respectively) and include 1 participant in CsA and 2 in Tofacitinib LI from before dose reduction to 5 mg by Month 18 was implemented (protocol Amendment 1) | Posted | Number | Percentage of Participants | Months 12 through 72. |
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| Primary | Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min]) | Glomerular filtration rate (GFR): an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous (IV) bolus over 5 minutes immediately after morning dosing of Tofacitinib or CsA on day of GFR evaluation. Blood samples for iohexol (3 millilitres [mL] each to provide a minimum of 1 mL serum) were collected into appropriately labeled tubes containing no additives at 120, 180, 240, and 300 minutes after the end of the iohexol IV bolus. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure. | Full analysis set (FAS, which was defined the same as the Safety Analysis Set). The analysis included 1 participant in CsA and 2 in Tofacitinib LI from before protocol Amendment 1. Only subjects at Month 36 with GFR calculations were included. | Posted | Least Squares Mean | Standard Error | mL/min | Month 36 |
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| Primary | Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36 | Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]). The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 36 Banff-CS greater than the implantation biopsy score indicated progression of lesions. | FAS. Only participants with Banff CS values at both Day 0 and Month 36 visits were included. | Posted | Number | Percentage of Participants | Month 36 |
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| Primary | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | BPAR was category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | FAS. n is the number of participants remaining at risk at each visit. | Posted | Number | 60% Confidence Interval | Percentage of Participants | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Primary | Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit | Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | FAS. n is the number of participants remaining at risk at each visit. | Posted | Number | 60% Confidence Interval | Percentage of Participants | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Efficacy failure was the first occurrence of BPAR diagnosed by the central pathologist or graft loss including participant death. BPAR (category acute rejection) was interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | FAS. n is the number of participants remaining at risk at each visit. | Posted | Number | 60% Confidence Interval | Percentage of Participants | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit | Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection was calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. | FAS. n is the number of participants remaining at risk at each visit. | Posted | Number | 60% Confidence Interval | Percentage of Participants | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit | Graft loss was defined as graft nephrectomy, subject death, retransplantation, or return to dialysis for at least 6 consecutive weeks. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit. | FAS. n is the number of participants remaining at risk at each visit. | Posted | Number | 60% Confidence Interval | Percentage of participants | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit. | FAS. n is the number of participants remaining at risk at each visit. | Posted | Number | 60% Confidence Interval | Percentage of Participants | Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Percentage of Participants Discontinuing From the Study | Discontinuations were due to any reason including those occurring as a result of protocol Amendments 3 and 4. | Safety Analysis Set | Posted | Number | Percentage of Participants | Months 12 through 72. |
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| Secondary | Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | mg/dL | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | mg/dL | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | mg/dL | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Safety Population. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | mg/dL | Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit | Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Mean | Standard Deviation | k/mm^3 | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up |
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| Secondary | Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit | Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Mean | Standard Deviation | g/dL | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up |
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| Secondary | Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Mean | Standard Deviation | Percentage | Months 24, 36, 48, 60, 72 |
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| Secondary | Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit | Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A compund symmetry variance-covariance structure was used. | Safety Population. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | mg/dL | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Percentage of Participants by Proteinuria Category by Visit | Proteinuria was defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Number | Percentage of Participants | Months 24, 36, 48, 60, 72 and Follow-up |
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| Secondary | Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Nankivell formula, where: Creatinine clearance (mL/min) = 6.7/serum creatinine (millimols per litre [mmol/L]) - serum urea (mmol/dL)/2 + actual body weight (kilograms [kg])/4 - 100/Height (metres [m])^2 + (35 for male or 25 for female). A normal GFR for adults is > 90 mL/min. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | minutes per milliliter (min/mL) | Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR (mL/min) was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | min/mL | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR (mL/min/1.73 m^2) by MDRD equation = 170 * (serum creatinine [mg/dL])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration [mg/dL])^(-0.170) * (serum albumin concentration [g/dL])^(0.318). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure. Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used. | Safety Analysis Set. | Posted | Least Squares Mean | Standard Error | mL/min/1.73m^2 | Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 |
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| Secondary | Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36 | SF-36 v2 is a self-administered 36-item generic health status measure with 8 general health concepts which are the weighted sums of the questions in their section: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each scale is transformed into a 0 (minimum) to 100 (maximum) scale on the assumption each question carries equal weight. These concepts were also summarized into 2 summary scores; Physical Component Summary and Mental Component Summary (both a 0-100 scale). The 8 subscales, 2 summary scores and transition Question 2 (TR Scale, measured on a scale of 1 [minimum] to 5 [maximum]) were subjected to analysis. Higher domain, summary scores, and TR scale scores indicate better health status. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. First-order autoregressive variance-covariance structure was used. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | Score on a scale | Months 24, 36 |
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| Secondary | Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36 | ESRD-SCL: a 43-item disease specific self-administered questionnaire. Participants' rated the question "At the moment,how much do you suffer?" for each item on a 5 point scale, range (Ra) from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: Cardiac and Renal (CR) dysfunction; Ra 0 to 28, Increased(In) Growth of Gum and Hair (IGGH); Ra 0 to 20, Limited Cognitive Capacity (LCC); Ra 0 to 32, Limited Physical Capacity (LPC); Ra 0 to 40, Side Effects (SEs) of Corticosteroids; Ra 0 to 20, Transplantation Associated Psychological Distress (TAPD); Ra 0 to 32. Total Score: 0 to 172, higher scores indicate greater dysfunction. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | Score on a scale | Months 24, 36 |
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| Secondary | Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36 | SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia; consists of 3 subscales: Pain Intensity (PI, 6-items to assess pain and intensity of abdominal discomfort; Range: 2 to 47, higher score indicates greater pain and abdominal discomfort), Non-Pain Symptoms (NPS, 7-items to assess severity and impact of non-pain symptoms: burping/belching, heartburn, bloating, flatulence, sour taste, nausea, and bad breath; Range: 7 to 35, higher scores indicate increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with abdominal discomfort; Range: 2 to 23, higher scores indicate more satisfaction). Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used. | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Least Squares Mean | Standard Error | Score | Months 24, 36 |
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| Secondary | Mean Trough Levels of Tofacitinib by Visit | The dates and times were recorded for the 6 doses of tofacitinib administered before each scheduled pharmacokinetic (PK) sampling. The participant was instructed to follow a 12 hourly schedule for these 6 doses of tofacitinib, with each dose administered within 1 hour of the scheduled time. Trough samples were collected 0 to 10 minutes prior to the morning dose. 1 hour postdose samples were required within 10 minutes of the nominal time point. Samples taken at -2 hours predose and at time points >1 hour post dose were required within 30 minutes of the nominal time point. | Safety Analysis Set. n is the number of participants with the assessment at each time point. | Posted | Mean | Standard Deviation | ng/mL | Months 18 and 24 (-2 hours, predose, 1 hour, 2 hours), Month 30 (predose, 1 hour and 2 hours), Month 36 (predose, 1, 2, and 4 hours), Months 42, 48, 54, 60, 66, 72 (predose and 2 hours) |
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| Secondary | Mean Trough Levels of Cyclosporine by Visit | All CsA samples were taken predose (collected 0 to 10 minutes prior to the morning dose). | Safety Analysis Set. n is the number of participants with the assessment at each visit. | Posted | Mean | Standard Deviation | ng/mL | Predose: Months 18, 24, 36, 48, 60, 72 |
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Adverse events (serious and non-serious) were recorded on the Case Report Form from the time the subject had taken at least 1 dose of study treatment through the follow-up visit at Month 74 or 2 months following discontinuation of treatment.
The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyclosporine | CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). | 40 | 64 | 49 | 64 | ||
| EG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). | 32 | 60 | 55 | 60 | ||
| EG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). | 31 | 54 | 45 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Coronary artery dissection | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA version 18.0 | Systematic Assessment |
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| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA version 18.0 | Systematic Assessment |
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| Hyperparathyrodism | Endocrine disorders | MedDRA version 18.0 | Systematic Assessment |
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| Hyperparathyroidism tertiary | Endocrine disorders | MedDRA version 18.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA version 18.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Gastric polyps | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Intestinal dilatation | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Swollen tongue | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Drug ineffective | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Impaired healing | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA version 18.0 | Systematic Assessment |
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| Kidney transplant rejection | Immune system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Transplant rejection | Immune system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Aspergilloma | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Cellulitis staphylococcal | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Diabetic foot infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Gas gangrene | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Mycobacterium chelonae infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Exposure via father | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Renal transplant failure | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Transplant dysfunction | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Urethral injury | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Brain mass | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Complex regional pain syndrome | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA version 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Vocal cord cyst | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Superior vena cava occlusion | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Epstein-Barr viraemia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Impaired fasting glucose | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Vulval disorder | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
| |
| Postmenopause | Social circumstances | MedDRA version 18.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| C479163 | tofacitinib |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
|
| Month 18 (n=57,52,41) |
|
| Month 24 (n=54,48,34) |
|
| Month 30 (n=49,34,23) |
|
| Month 36 (n=46,28,12) |
|
| Month 42 (n=40,28,11) |
|
| Month 48 (n=37,28,11) |
|
| Month 54 (n=36,25,10) |
|
| Month 60 (n=34,21,10) |
|
| Month 66 (n=29,19,8) |
|
| Month 72 (n=24,15,7) |
|
Month 15 |
| Wald Test |
| 0.0873 |
| Estimated rate difference |
| 10.71 |
| Standard Error of the Mean |
| 6.26 |
| 2-Sided |
| 60 |
| 5.44 |
| 15.98 |
Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference |
| Superiority or Other |
| Month 18 | Wald Test | 0.4912 | Estimated rate difference | 3.93 | Standard Error of the Mean | 5.71 | 2-Sided | 60 | -0.87 | 8.74 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 18 | Wald Test | 0.0942 | Estimated rate difference | 11.06 | Standard Error of the Mean | 6.61 | 2-Sided | 60 | 5.50 | 16.62 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 24 | Wald Test | 0.2499 | Estimated rate difference | 7.31 | Standard Error of the Mean | 6.36 | 2-Sided | 60 | 1.96 | 12.66 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 24 | Wald Test | 0.0580 | Estimated rate difference | 13.47 | Standard Error of the Mean | 7.10 | 2-Sided | 60 | 7.49 | 19.45 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 30 | Wald Test | 0.0750 | Estimated rate difference | 12.62 | Standard Error of the Mean | 7.09 | 2-Sided | 60 | 6.66 | 18.59 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 30 | Wald Test | 0.0316 | Estimated rate difference | 16.66 | Standard Error of the Mean | 7.75 | 2-Sided | 60 | 10.14 | 23.19 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 36 | Wald Test | 0.0783 | Estimated rate difference | 13.21 | Standard Error of the Mean | 7.50 | 2-Sided | 60 | 6.90 | 19.53 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 36 | Wald Test | 0.0266 | Estimated rate difference | 20.27 | Standard Error of the Mean | 9.14 | 2-Sided | 60 | 12.58 | 27.96 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 42 | Wald Test | 0.0783 | Estimated rate difference | 13.21 | Standard Error of the Mean | 7.50 | 2-Sided | 60 | 6.90 | 19.53 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 42 | Wald Test | 0.0266 | Estimated rate difference | 20.27 | Standard Error of the Mean | 9.14 | 2-Sided | 60 | 12.58 | 27.96 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 48 | Wald Test | 0.1545 | Estimated rate difference | 11.02 | Standard Error of the Mean | 7.74 | 2-Sided | 60 | 4.51 | 17.54 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 48 | Wald Test | 0.0528 | Estimated rate difference | 18.08 | Standard Error of the Mean | 9.34 | 2-Sided | 60 | 10.22 | 25.94 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 54 | Wald Test | 0.0968 | Estimated rate difference | 14.03 | Standard Error of the Mean | 8.45 | 2-Sided | 60 | 6.92 | 21.14 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 54 | Wald Test | 0.0966 | Estimated rate difference | 15.83 | Standard Error of the Mean | 9.53 | 2-Sided | 60 | 7.81 | 23.85 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 60 | Wald Test | 0.0507 | Estimated rate difference | 17.07 | Standard Error of the Mean | 8.74 | 2-Sided | 60 | 9.72 | 24.42 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 60 | Wald Test | 0.0966 | Estimated rate difference | 15.83 | Standard Error of the Mean | 9.53 | 2-Sided | 60 | 7.81 | 23.85 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 66 | Wald Test | 0.0507 | Estimated rate difference | 17.07 | Standard Error of the Mean | 8.74 | 2-Sided | 60 | 9.72 | 24.42 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 66 | Wald Test | 0.0966 | Estimated rate difference | 15.83 | Standard Error of the Mean | 9.53 | 2-Sided | 60 | 7.81 | 23.85 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 72 | Wald Test | 0.0574 | Estimated rate difference | 18.17 | Standard Error of the Mean | 9.56 | 2-Sided | 60 | 10.12 | 26.22 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 72 | Wald Test | 0.0749 | Estimated rate difference | 21.08 | Standard Error of the Mean | 11.84 | 2-Sided | 60 | 11.12 | 31.04 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 12 | Wald Test | 0.4116 | Estimated rate difference | 3.65 | Standard Error of the Mean | 4.44 | 2-Sided | 60 | -0.09 | 7.38 | Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| Month 12 | Wald Test | 0.7895 | Estimated rate difference | -0.98 | Standard Error of the Mean | 3.69 | 2-Sided | 60 | -4.09 | 2.12 | Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference | Superiority or Other |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
|
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| OG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG001 |
| Tofacitinib Less Intensive (LI) |
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG001 |
| Tofacitinib Less Intensive (LI) |
Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG001 | Tofacitinib Less Intensive (LI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
| OG002 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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| OG001 | Tofacitinib More Intensive (MI) | Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study). |
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