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临床试验/NCT01976364
NCT01976364已完成3 期

A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS

Pfizer151 个研究点 分布在 3 个国家目标入组 686 人开始时间: 2014年2月17日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
686
试验地点
151
主要终点
Number of Adverse Events (AEs) by Severity
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

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication.

This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The sub-study will be participant, care provider, investigator and outcomes assessor masked.

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

  • •Previous participation in qualifying PsA study involving tofacitinib

排除标准

  • •Time from End of Study visit of qualifying study is >3 months.
  • •Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.
  • •Sub-study Inclusion Criteria:
  • •Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study
  • •Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)
  • •Sub-study Exclusion Criteria:
  • •Subjects who are receiving methotrexate by a route other than oral

研究组 & 干预措施

Tofacitinib

Experimental

干预措施: Tofacitinib (Drug)

Tofacitinib

Experimental

干预措施: Methotrexate (Drug)

Tofacitinib

Experimental

干预措施: Placebo Methotrexate (Drug)

结局指标

主要结局

Number of Adverse Events (AEs) by Severity

时间窗: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

时间窗: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Number of Participants With Abnormal Clinical Laboratory Values

时间窗: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin \[total, direct, indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.

Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6

时间窗: Sub-study: Baseline (Day 1), Month 6

HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.

Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6

时间窗: Sub-study: Baseline (Day 1), Month 6

PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.

Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values

时间窗: Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)

Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin\[total,direct,indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.

次要结局

  • Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response(Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)(Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response(Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response(Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36(Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12)
  • Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12(Sub-study: Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12(Months 1, 3, 6, 9 and 12)
  • Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12)
  • Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12(Sub-study: Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36(Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36)
  • Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12(Sub-study: Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12(Sub-study: Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)
  • Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12(Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (151)

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