Back to resultsEvaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab (ROCkIES)
Primary Purpose
Moderate to Severe Rheumatoid Arthritis
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Etanercept
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Rheumatoid Arthritis focused on measuring rheumatoid arthritis, etanercept, arthritis, adalimumab failure to respond, loss of response to adalimumab, ACR20, methotrexate, Swollen joints, tender joints
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent
- Diagnosed with moderate to severe rheumatoid arthritis for at least 6 months
- Active RA with at least 3 swollen and tender joints
- Failure to respond to a combination treatment of adalimumab and methotrexate (must have taken combination at least 3 months) or loss of a satisfactory response to the combination of adalimumab and methotrexate, which was taken for at least 6 months (if currently taking adalimumab must complete 2 weeks without it prior to starting study drug)
- Negative for hepatitis B and C
- Negative serum and urine pregnancy tests before starting study
- currently taking (stable dose) 15 mg methotrexate weekly for at least 8 weeks/has been taking methotrexate for at least 12 weeks total - lower dose of 10 mg per week is permitted with documented intolerability
- Normal chest X-ray within 3 months
- Negative testing for tuberculosis (TB)
Exclusion Criteria:
- Class IV RA (wheel-chair or bed-bound)
- Significant concurrent medical conditions, including: (uncontrolled type 1 diabetes, poorly controlled type 2 diabetes, symptomatic heart failure, myocardial infarction in past year, history of unstable angina within past year, uncontrolled hypertension, severe chronic pulmonary disease, major chronic inflammatory or connective tissue disease other than RA, Multiple sclerosis, active malignancy, or history of cancer, alcoholic hepatitis or history of alcoholic liver disease)
- Other inclusion/exclusion criteria may apply
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etanercept
Arm Description
Participants received etanercept 50 mg administered subcutaneously once a week with methotrexate for 24 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Secondary Outcome Measures
Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Percentage of Participants With an ACR 20 Response at Week 24
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Percentage of Participants With an ACR 50 Response at Weeks 12 and 24
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Percentage of Participants With an ACR 70 Response at Weeks 12 and 24
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)
The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP) level
Patient's global assessment of disease activity assessed on a score from 0 to 100.
The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement.
Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline
The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity.
Percentage of Participants With DAS 28-CRP < 3.2
The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability).
Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12
The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.
Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24
The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.
Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01927757
Brief Title
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
Acronym
ROCkIES
Official Title
A Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic Agent
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Business decision due to slow enrollment
Study Start Date
May 6, 2013 (Actual)
Primary Completion Date
June 11, 2015 (Actual)
Study Completion Date
June 11, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Rheumatoid Arthritis
Keywords
rheumatoid arthritis, etanercept, arthritis, adalimumab failure to respond, loss of response to adalimumab, ACR20, methotrexate, Swollen joints, tender joints
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etanercept
Arm Type
Experimental
Arm Description
Participants received etanercept 50 mg administered subcutaneously once a week with methotrexate for 24 weeks
Intervention Type
Biological
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel®
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Background methotrexate at least 15 mg weekly
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
Description
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup
Description
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup
Description
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With an ACR 20 Response at Week 24
Description
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Time Frame
Baseline and Week 24
Title
Percentage of Participants With an ACR 50 Response at Weeks 12 and 24
Description
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Time Frame
Baseline and Weeks 12 and 24
Title
Percentage of Participants With an ACR 70 Response at Weeks 12 and 24
Description
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.
Time Frame
Baseline and Weeks 12 and 24
Title
Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)
Description
The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count;
C-reactive protein (CRP) level
Patient's global assessment of disease activity assessed on a score from 0 to 100.
The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement.
Time Frame
Baseline and weeks 12 and 24
Title
Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline
Description
The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity.
Time Frame
Baseline and weeks 12 and 24
Title
Percentage of Participants With DAS 28-CRP < 3.2
Description
The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity.
Time Frame
Weeks 12 and 24
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability).
Time Frame
Baseline and weeks 12 and 24
Title
Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12
Description
The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.
Time Frame
Baseline and Week 12
Title
Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24
Description
The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.
Time Frame
Baseline and Week 24
Title
Work Productivity and Activity Impairment (WPAI)
Description
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
Time Frame
Baseline, week 12 and week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent
Diagnosed with moderate to severe rheumatoid arthritis for at least 6 months
Active RA with at least 3 swollen and tender joints
Failure to respond to a combination treatment of adalimumab and methotrexate (must have taken combination at least 3 months) or loss of a satisfactory response to the combination of adalimumab and methotrexate, which was taken for at least 6 months (if currently taking adalimumab must complete 2 weeks without it prior to starting study drug)
Negative for hepatitis B and C
Negative serum and urine pregnancy tests before starting study
currently taking (stable dose) 15 mg methotrexate weekly for at least 8 weeks/has been taking methotrexate for at least 12 weeks total - lower dose of 10 mg per week is permitted with documented intolerability
Normal chest X-ray within 3 months
Negative testing for tuberculosis (TB)
Exclusion Criteria:
Class IV RA (wheel-chair or bed-bound)
Significant concurrent medical conditions, including: (uncontrolled type 1 diabetes, poorly controlled type 2 diabetes, symptomatic heart failure, myocardial infarction in past year, history of unstable angina within past year, uncontrolled hypertension, severe chronic pulmonary disease, major chronic inflammatory or connective tissue disease other than RA, Multiple sclerosis, active malignancy, or history of cancer, alcoholic hepatitis or history of alcoholic liver disease)
Other inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Research Site
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Research Site
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Research Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Site
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Research Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Research Site
City
Dunedin
State/Province
Florida
ZIP/Postal Code
34698
Country
United States
Facility Name
Research Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33774
Country
United States
Facility Name
Research Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Research Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Research Site
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Research Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Research Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Research Site
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Research Site
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Research Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Research Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Research Site
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Research Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Research Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Research Site
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Research Site
City
Quispamsis
State/Province
New Brunswick
ZIP/Postal Code
E2E 4J8
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
Research Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 1E2
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1Y3
Country
Canada
Facility Name
Research Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Research Site
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
28900875
Citation
Bessette L, Khraishi M, Kivitz AJ, Kaliyaperumal A, Grantab R, Poulin-Costello M, Isaila M, Collier D. Single-Arm Study of Etanercept in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment. Rheumatol Ther. 2017 Dec;4(2):391-404. doi: 10.1007/s40744-017-0079-x. Epub 2017 Sep 12.
Results Reference
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Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
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