Study Stopped
Business decision due to slow enrollment
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
ROCkIES
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
1 other identifier
interventional
90
3 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2013
Typical duration for phase_4
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2013
CompletedFirst Submitted
Initial submission to the registry
June 5, 2013
CompletedFirst Posted
Study publicly available on registry
August 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2015
CompletedResults Posted
Study results publicly available
July 11, 2016
CompletedJanuary 30, 2018
January 1, 2018
2.1 years
June 5, 2013
May 30, 2016
January 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Week 12
Secondary Outcomes (12)
Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup
Baseline and Week 12
Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup
Baseline and Week 12
Percentage of Participants With an ACR 20 Response at Week 24
Baseline and Week 24
Percentage of Participants With an ACR 50 Response at Weeks 12 and 24
Baseline and Weeks 12 and 24
Percentage of Participants With an ACR 70 Response at Weeks 12 and 24
Baseline and Weeks 12 and 24
- +7 more secondary outcomes
Study Arms (1)
Etanercept
EXPERIMENTALParticipants received etanercept 50 mg administered subcutaneously once a week with methotrexate for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (45)
Research Site
Tuscaloosa, Alabama, 35406, United States
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
Covina, California, 91723, United States
Research Site
Hemet, California, 92543, United States
Research Site
Murrieta, California, 92563, United States
Research Site
San Diego, California, 92108, United States
Research Site
Victorville, California, 92395, United States
Research Site
Denver, Colorado, 80230, United States
Research Site
Brandon, Florida, 33511, United States
Research Site
Dunedin, Florida, 34698, United States
Research Site
Largo, Florida, 33774, United States
Research Site
Palm Harbor, Florida, 34684, United States
Research Site
Tampa, Florida, 33609, United States
Research Site
Lawrenceville, Georgia, 30046, United States
Research Site
Bowling Green, Kentucky, 42101, United States
Research Site
Paducah, Kentucky, 42003, United States
Research Site
Fall River, Massachusetts, 02720, United States
Research Site
Battle Creek, Michigan, 49017, United States
Research Site
Lincoln, Nebraska, 68516, United States
Research Site
Smithtown, New York, 11787, United States
Research Site
Charlotte, North Carolina, 28210, United States
Research Site
Middleburg Heights, Ohio, 44130, United States
Research Site
Duncansville, Pennsylvania, 16635, United States
Research Site
Hixson, Tennessee, 37343, United States
Research Site
Austin, Texas, 78731, United States
Research Site
Corpus Christi, Texas, 78404, United States
Research Site
Houston, Texas, 77034, United States
Research Site
Victoria, Texas, 77901, United States
Research Site
Chesapeake, Virginia, 23320, United States
Research Site
Roanoke, Virginia, 24016, United States
Research Site
Seattle, Washington, 98133, United States
Research Site
Clarksburg, West Virginia, 26301, United States
Research Site
Victoria, British Columbia, V8V 3P9, Canada
Research Site
Quispamsis, New Brunswick, E2E 4J8, Canada
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Research Site
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Research Site
Burlington, Ontario, L7R 1E2, Canada
Research Site
Hamilton, Ontario, L8N 1Y2, Canada
Research Site
Mississauga, Ontario, L5M 2V8, Canada
Research Site
Toronto, Ontario, M5G 1X5, Canada
Research Site
Montreal, Quebec, H2L 1S6, Canada
Research Site
Montreal, Quebec, H3T 1Y3, Canada
Research Site
Québec, Quebec, G1V 3M7, Canada
Research Site
Québec, Quebec, G1W 4R4, Canada
Research Site
Caguas, 00725, Puerto Rico
Related Publications (1)
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.
PMID: 28900875BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2013
First Posted
August 23, 2013
Study Start
May 6, 2013
Primary Completion
June 11, 2015
Study Completion
June 11, 2015
Last Updated
January 30, 2018
Results First Posted
July 11, 2016
Record last verified: 2018-01