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Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients

2018年2月20日 更新者：Pfizer

A Phase 2, Multicenter, Open-label, Active Comparator-controlled, Extension Trial To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 In Renal Allograft Recipients

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

178

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90048
        • Cedars-Sinai Medical Center
      • Los Angeles、California、アメリカ、90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles、California、アメリカ、90095
        • UCLA Medical Center
      • Los Angeles、California、アメリカ、90048
        • Cedars-Sinai MedicalCenter
      • Palo Alto、California、アメリカ、94305
        • Stanford University Medical Center
      • Palo Alto、California、アメリカ、94304
        • Stanford School of Medicine
      • San Diego、California、アメリカ、92123
        • California Institute of Renal Research
      • San Diego、California、アメリカ、92123
        • Sharp Memorial Hospital
      • San Diego、California、アメリカ、92123
        • Balboa Institute of Transplantation
      • San Francisco、California、アメリカ、94115
        • California Pacific Medical Center
      • San Francisco、California、アメリカ、94115
        • California Pacific Medical Center - Pacific Campus
      • San Francisco、California、アメリカ、94143
        • UCSF Medical Center - Long Hospital
      • San Francisco、California、アメリカ、94143
        • USCF Medical Center - Connie Frank Transplant Center
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • University of Colorado Denver
    • Connecticut
      • New Haven、Connecticut、アメリカ、06504
        • Yale-New Haven Hospital
      • New Haven、Connecticut、アメリカ、06510
        • Yale Physicians Building
    • Florida
      • Gainesville、Florida、アメリカ、32610
        • University of Florida
      • Tampa、Florida、アメリカ、33606
        • Tampa General Hospital
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • Northwestern University Feinberg School of Medicine
      • Chicago、Illinois、アメリカ、60611
        • NUCATS's Clinical Research Unit
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109
        • University of Michigan Health System
      • Detroit、Michigan、アメリカ、48202
        • Henry Ford Hospital
      • Flint、Michigan、アメリカ、48503
        • Hurley Medical Center
    • Missouri
      • Saint Louis、Missouri、アメリカ、63110
        • Washington University School of Medicine
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27514
        • Investigational Drug Services (IDS) / UNC Healthcare
      • Chapel Hill、North Carolina、アメリカ、27514
        • Transplant Clinic/UNC Heathcare
      • Chapel Hill、North Carolina、アメリカ、27599-7211
        • UNC Department of Surgery, Clinical Trials Consortium
      • Chapel Hill、North Carolina、アメリカ、27599-7211
        • UNC Department of Surgery/Abdominal Transplant Division
      • Chapel Hill、North Carolina、アメリカ、27599-7360
        • Division of Pharmacotherapy, School of Pharmacy, University of North Carolina at Chapel Hill
      • Chapel Hill、North Carolina、アメリカ、27599
        • University of North Carolina, Department of Medicine/Nephrology
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19102
        • Hahnemann University Hospital
      • Philadelphia、Pennsylvania、アメリカ、19102
        • Drexel University College of Medicine - Hahnemann University Hospital
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • Medical University of South Carolina, Department of Transplantation Surgery
      • Charleston、South Carolina、アメリカ、29425
        • Nephrology clinic
    • Texas
      • Dallas、Texas、アメリカ、75246
        • Baylor University Medical Center
      • Dallas、Texas、アメリカ、75204
        • Dallas Transplant Institute
      • Dallas、Texas、アメリカ、75246
        • Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center
  • イタリア
      • Bologna、イタリア、40138
        • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi
    • RM
      • Roma、RM、イタリア、00168
        • Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore
  • オランダ
      • Rotterdam、オランダ、3015 GD
        • Erasmus Medisch Centrum
  • オーストラリア
    • New South Wales
      • Camperdown、New South Wales、オーストラリア、2050
        • Royal Prince Alfred Hospital
      • Westmead、New South Wales、オーストラリア、2145
        • Westmead Hospital, Department of Renal Medicine
    • South Australia
      • Adelaide、South Australia、オーストラリア、5000
        • Central Northern Adelaide Renal and Transplantation Service
      • Woodville、South Australia、オーストラリア、5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Parkville、Victoria、オーストラリア、3050
        • Royal Melbourne Hospital
  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 2B7
        • University of Alberta Hospital
  • スペイン
      • Barcelona、スペイン、08036
        • Hospital Clínic i Provincial de Barcelona
    • Barcelona
      • Hospitalet de Llobregat、Barcelona、スペイン、08907
        • Hospital Universitari de Bellvitge
  • チェコ
      • Praha 4 Krc、チェコ、140 21
        • Institut Klinicke a Experimentalni Mediciny
  • ドイツ
      • Berlin、ドイツ、10117
        • Charité - Universitätsmedizin Berlin
  • ノルウェー
      • Oslo、ノルウェー、0372
        • Oslo universitetssykehus HF- Rikshospitalet
  • フランス
      • Paris Cedex 15、フランス、75743
        • Hôpital Necker
      • Vandoeuvre Les Nancy、フランス、54500
        • CHRU de Nancy-Brabois - Service de Nephrologie
  • ブラジル
      • Sao Paulo、ブラジル、04038-002
        • Hospital Do Rim E Hipertensão
    • RS
      • Porto Alegre、RS、ブラジル、90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
    • SP
      • Sao Paulo、SP、ブラジル、04038-002
        • Hospital Do Rim E Hipertensão
      • Sao Paulo、SP、ブラジル、04039-033
        • Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao
  • ベルギー
      • Leuven、ベルギー、3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Brussels
      • Anderlecht、Brussels、ベルギー、1070
        • Hôpital Erasme
  • ポルトガル
      • Coimbra、ポルトガル、3000-075
        • Hospitais da Universidade de Coimbra, EPE
      • Lisboa、ポルトガル、1069-166
        • Hospital Curry Cabral
  • ポーランド
      • Wroclaw、ポーランド、50-556
        • Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu
  • 大韓民国
      • Seoul、大韓民国、110-744
        • Seoul National University Hospital
      • Seoul、大韓民国、120-752
        • Department of Surgery, Yonsei University College of Medicine Severance Hospital
      • Seoul、大韓民国、138-736
        • Asan Medical Center, Department of Surgery

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Subjects who successfully completed Study A3921030

Exclusion Criteria:

  • Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Treatment Arm 1
Treatment Arm 1 will also receive standard of care medications
薬：シクロスポリン
標準治療
実験的：Treatment Arm 2
Treatment Arm 2 will also receive standard of care medications
薬：CP-690,550
CP-690,550 tablets dosed BID Months 12-72
実験的：Treatment Arm 3
Treatment Arm 3 will also receive standard of care medications
薬：CP-690,550
CP-690,550 tablets dosed BID Months 12-72

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
時間枠：Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 12 through 72.
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])
時間枠：Month 36
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
時間枠：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.
Month 36
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
時間枠：Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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

二次結果の測定

結果測定
メジャーの説明
時間枠
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
時間枠：Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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.
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
時間枠：Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 12 through 72.
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
時間枠：Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
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
時間枠：Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
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
時間枠：Months 24, 36, 48, 60, 72
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
時間枠：Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
時間枠：Months 24, 36, 48, 60, 72 and Follow-up
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
時間枠：Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

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
時間枠：Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

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
時間枠：Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

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
時間枠：Months 24, 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
時間枠：Months 24, 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
時間枠：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
時間枠：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)
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
時間枠：Predose: Months 18, 24, 36, 48, 60, 72
All CsA samples were taken predose (collected 0 to 10 minutes prior to the morning dose).
Predose: Months 18, 24, 36, 48, 60, 72

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

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研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2008年8月1日

一次修了 (実際)

2015年3月1日

研究の完了 (実際)

2015年6月1日

試験登録日

最初に提出

2008年4月9日

QC基準を満たした最初の提出物

2008年4月9日

最初の投稿 (見積もり)

2008年4月15日

学習記録の更新

投稿された最後の更新 (実際)

2018年2月23日

QC基準を満たした最後の更新が送信されました

2018年2月20日

最終確認日

2018年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • A3921050
  • 2008-002345-23 (EudraCT番号)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

シクロスポリンの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in El Salvador

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
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