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临床试验/NCT01484561
NCT01484561已完成1 期

A Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis

Pfizer1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2012年4月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Pfizer
入组人数
148
试验地点
1
主要终点
Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of kidney function in patients with active rheumatoid arthritis (RA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis by satisfying at least four of the seven criteria.
  • •The patient must have active disease at both Screening and predose on Day 1 of Period
  • •Patient must have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or intolerance.

排除标准

  • •Pregnant or lactating women
  • •Serious medical conditions that would make treatment with CP-690,550 potentially unsafe.
  • •A patient who has a history of asthma, multiple allergies or severe allergy (eg, anaphylaxis) to any substance. In particular, a history of allergy to iodine, povidone-iodine, iohexol or other iodinated contrast media.

研究组 & 干预措施

Sequence 2

Placebo Comparator

干预措施: Placebo (Drug)

Sequence 1

Active Comparator

干预措施: CP-690,550 or Placebo (Drug)

结局指标

主要结局

Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)

时间窗: Day 1 of Period 1, Day 43 of Period 1

Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m\^2) body surface area. A normal GFR is greater than (\>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.

次要结局

  • Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR(Day 1 of Period 1, Day 29 of Period 2)
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR(Day 43 of Period 1, Day 29 of Period 2)
  • Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)(Day 1 of Period 1, Day 43 of Period 1)
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD(Day 1 of Period 1, Day 29 of Period 2)
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD(Day 43 of Period 1, Day 29 of Period 2)
  • Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation(Day 1 of Period 1, Day 43 of Period 1)
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation(Day 1 of Period 1, Day 29 of Period 2)
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation(Day 43 of Period 1, Day 29 of Period 2)
  • Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine(Day 1 of Period 1, Day 43 of Period 1)
  • Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine(Day 1 of Period 1, Day 29 of Period 2)
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine(Day 43 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count(Day 43 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 1 From Baseline in CRP(Day 1 of Period 1, Day 43 of Period 1)
  • LS Mean Change at End of Period 2 From Baseline in CRP(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 in CRP(Day 43 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)(Day 1 of Period 1, Day 43 of Period 1)
  • LS Mean Change at End of Period 2 From Baseline in PGAA(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 in PGAA(Day 43 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis(Day 1 of Period 1, Day 43 of Period 1)
  • LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis(Day 43 of Period 1, Day 29 of Period 1)
  • LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain(Day 1 of Period 1, Day 43 of Period 1)
  • LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain(Day 43 of Period 2, Day 29 of Period 2)
  • LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score(Day 1 of Period 1, Day 43 of Period 1)
  • LS Mean Change at End of Period 2 From Baseline HAQ-DI Score(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score(Day 43 of Period 1, Day 29 of Period 2)
  • Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response(Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2)
  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2)
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2)
  • Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])(Day 1 of Period 1, Day 43 of Period 1)
  • LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)(Day 43 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)(Day 1 of Period 1, Day 43 of Period 1)
  • LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)(Day 43 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count(Day 1 of Period 1, Day 43 of Period 1)
  • LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count(Day 1 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count(Day 43 of Period 1, Day 29 of Period 2)
  • LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count(Day 1 of Period 1, Day 43 of Period 1)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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