Back to resultsStudy Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Etanercept
Etanercept
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, Arthritis
Eligibility Criteria
Inclusion Criteria:
- Must be Japanese and live in Japan
- Must be age 20 to 75 years
- Diagnosed less than or equal to 10 years from time of first visit
Exclusion Criteria:
- Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab in the past
- Patient with other rheumatic diseases or conditions that could predispose the patient to infection
- Pregnant or lactating women
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Secondary Outcome Measures
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Change From Baseline in Erosion Score at Weeks 24 and 52
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Percentage of Participants With no Progression of Joint Destruction at Week 52
Absence of joint destruction defined by 3 categories (mTSS change <=0.5, <=3.0, and <smallest detectable difference [SDD] where SDDs were scores >3.0). mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score).
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
American College of Rheumatology (ACR) swollen joint count was an assessment of 68 joints. Joints classified as either swollen or not swollen. Change = scores at observation minus score at Baseline, and total possible scores ranged from -68 to 68. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
71 joints assessed by the investigator using criteria based on pressure and joint manipulation. Change = scores at observation minus score at Baseline, and total possible scores ranged from -71 to 71. An increase in tender joint count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Physician Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Patient's Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Morning stiffness in and around the joints lasting at least 1 hour before maximal improvement. Change = scores at observation minus score at Baseline. An increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
100 millimeter (mm) line (VAS) marked by participant. Intensity of pain range (over past week): 0mm = no pain to 100mm = worst possible pain. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
100mm line (VAS) marked by participant. Participants asked, "In general how would you rate your health over the last 2-3 weeks?" 0mm=very well to 100mm=extremely bad. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Change = scores at observation minus score at Baseline and total possible scores ranged from -3 to 3. An increase in score from baseline represented disease progression and/or joint worsening and a decrease represented improvement.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Percentage of Participants With an ACR50 Response
ACR50 response: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Percentage of Participants With an ACR70 Response
ACR70 response: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
DAS: weighted calculation of joint tenderness score (Ritchie Articular Index[RAI]), swollen joint count of 44 joints, natural logarithm (ln) of erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using VAS. RAI defined as sum of 26 possible 0 to 3 tender scores. DAS = 0.53938 square root (√) (RAI) + 0.06465 (swollen joint count) + 0.330 (ln ESR) + 0.00722 (GH). Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
DAS based on 28 painful joint counts, 28 swollen joint counts, ESR, and GH. DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH. Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).
Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
CRP: marker of inflammation. Higher level consistent with inflammation. Normal CRP range: 0 to 1.0 milligrams per deciliter (mg/dL).
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00445770
Brief Title
Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Official Title
A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
10 mg twice weekly, subcutaneous injection for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
25 mg, twice weekly, subcutaneous injection for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
up to 8 mg per week, oral dosing for 52 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
Description
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
Description
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time Frame
Week 24
Title
Change From Baseline in Erosion Score at Weeks 24 and 52
Description
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline, Week 24, and Week 52
Title
Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52
Description
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline, Week 24, and Week 52
Title
Percentage of Participants With no Progression of Joint Destruction at Week 52
Description
Absence of joint destruction defined by 3 categories (mTSS change <=0.5, <=3.0, and <smallest detectable difference [SDD] where SDDs were scores >3.0). mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score).
Time Frame
Baseline and Week 52
Title
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
American College of Rheumatology (ACR) swollen joint count was an assessment of 68 joints. Joints classified as either swollen or not swollen. Change = scores at observation minus score at Baseline, and total possible scores ranged from -68 to 68. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
71 joints assessed by the investigator using criteria based on pressure and joint manipulation. Change = scores at observation minus score at Baseline, and total possible scores ranged from -71 to 71. An increase in tender joint count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
Physician Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
Patient's Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
Morning stiffness in and around the joints lasting at least 1 hour before maximal improvement. Change = scores at observation minus score at Baseline. An increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
100 millimeter (mm) line (VAS) marked by participant. Intensity of pain range (over past week): 0mm = no pain to 100mm = worst possible pain. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
100mm line (VAS) marked by participant. Participants asked, "In general how would you rate your health over the last 2-3 weeks?" 0mm=very well to 100mm=extremely bad. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Change = scores at observation minus score at Baseline and total possible scores ranged from -3 to 3. An increase in score from baseline represented disease progression and/or joint worsening and a decrease represented improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Description
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Percentage of Participants With an ACR50 Response
Description
ACR50 response: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Percentage of Participants With an ACR70 Response
Description
ACR70 response: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
DAS: weighted calculation of joint tenderness score (Ritchie Articular Index[RAI]), swollen joint count of 44 joints, natural logarithm (ln) of erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using VAS. RAI defined as sum of 26 possible 0 to 3 tender scores. DAS = 0.53938 square root (√) (RAI) + 0.06465 (swollen joint count) + 0.330 (ln ESR) + 0.00722 (GH). Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
DAS based on 28 painful joint counts, 28 swollen joint counts, ESR, and GH. DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH. Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
CRP: marker of inflammation. Higher level consistent with inflammation. Normal CRP range: 0 to 1.0 milligrams per deciliter (mg/dL).
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Description
ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Other Pre-specified Outcome Measures:
Title
Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses
Time Frame
Weeks 12, 24, 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be Japanese and live in Japan
Must be age 20 to 75 years
Diagnosed less than or equal to 10 years from time of first visit
Exclusion Criteria:
Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab in the past
Patient with other rheumatic diseases or conditions that could predispose the patient to infection
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Pfizer Investigational Site
City
Goshogawara
State/Province
Aomori
ZIP/Postal Code
037-0053
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
Pfizer Investigational Site
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Pfizer Investigational Site
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-8543
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
8390863
Country
Japan
Facility Name
Pfizer Investigational Site
City
Munakata
State/Province
Fukuoka
ZIP/Postal Code
8113431
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0053
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8243
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kakogawa
State/Province
Hyogo
ZIP/Postal Code
6750009
Country
Japan
Facility Name
Pfizer Investigational Site
City
Katoh
State/Province
Hyougo
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yuki
State/Province
Ibaraki
ZIP/Postal Code
307-0001
Country
Japan
Facility Name
Pfizer Investigational Site
City
Komatsu
State/Province
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
2120014
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8522
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2310045
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9820032
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hyuga
State/Province
Miyazaki
ZIP/Postal Code
8830043
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ikoma
State/Province
Nara
ZIP/Postal Code
630-0293
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1111
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8549
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ota
State/Province
Tokyo
ZIP/Postal Code
1438541
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-0013
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukui
ZIP/Postal Code
9108561
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
814-0002
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
815-8588
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
8150063
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima
ZIP/Postal Code
7300031
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kagoshima
ZIP/Postal Code
8900067
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kagoshima
ZIP/Postal Code
891-0133
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kato city Fujita letter Higashiyama
ZIP/Postal Code
944-25
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumamoto
ZIP/Postal Code
8620965
Country
Japan
Facility Name
Pfizer Investigational Site
City
Miyagi
ZIP/Postal Code
9810112
Country
Japan
Facility Name
Pfizer Investigational Site
City
Miyazaki
ZIP/Postal Code
8800122
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toyama
ZIP/Postal Code
9338525
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32735145
Citation
Takeuchi T, Miyasaka N, Pedersen RD, Sugiyama N, Hirose T. Radiographic and clinical effects of 10 mg and 25 mg twice-weekly etanercept over 52 weeks in Japanese patients with active rheumatoid arthritis. Mod Rheumatol. 2021 Mar;31(2):319-325. doi: 10.1080/14397595.2020.1805142. Epub 2020 Sep 7.
Results Reference
derived
PubMed Identifier
30836801
Citation
Takeuchi T, Miyasaka N, Pedersen R, Sugiyama N, Hirose T. Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naive patients with active rheumatoid arthritis. Mod Rheumatol. 2020 Mar;30(2):259-268. doi: 10.1080/14397595.2019.1589918. Epub 2019 Mar 29.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A1-315&StudyName=Study%20Evaluating%20the%20Efficacy%20and%20Safety%20of%20Etanercept%20and%20Methotrexate%20in%20Japanese%20Subjects%20with%20Rheumatoid%20Arthritis
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
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