Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
NCT ID: NCT01313208
Last Updated: 2017-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
210 participants
INTERVENTIONAL
2011-03-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
etanercept
Administered by subcutaneous injection once weekly.
Placebo
Placebo subcutaneous injection
DMARD Therapy
Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
Etanercept
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.
All participants continued their DMARD treatment throughout the 24-week study period.
etanercept
Administered by subcutaneous injection once weekly.
DMARD Therapy
Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
Interventions
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etanercept
Administered by subcutaneous injection once weekly.
Placebo
Placebo subcutaneous injection
DMARD Therapy
Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months
* Moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) \> 3.2 and ≤ 5.1
* Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees)
* Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
Exclusion Criteria
* Class IV rheumatoid arthritis according to ACR revised response criteria
* Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
* Previously used more than one experimental biologic DMARD. Patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product
* Previously used more than one commercially available biologic DMARD. Subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples:
* No more than 4 injections of adalimumab
* No more than 8 (50 mg) injections of etanercept
* No more than 2 infusions of infliximab
* No more than 2 infusions of abatacept
* Additional inclusion (exclusion) criteria may apply
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Tuscaloosa, Alabama, United States
Research Site
Peoria, Arizona, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Encino, California, United States
Research Site
Hemet, California, United States
Research Site
Inglewood, California, United States
Research Site
La Jolla, California, United States
Research Site
Murrieta, California, United States
Research Site
Santa Maria, California, United States
Research Site
Tustin, California, United States
Research Site
Upland, California, United States
Research Site
Victorville, California, United States
Research Site
Denver, Colorado, United States
Research Site
Jacksonville, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Sebring, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Meridian, Idaho, United States
Research Site
Springfield, Illinois, United States
Research Site
Lexington, Kentucky, United States
Research Site
Frederick, Maryland, United States
Research Site
Lansing, Michigan, United States
Research Site
Saint Clair Shores, Michigan, United States
Research Site
Bismarck, North Dakota, United States
Research Site
Akron, Ohio, United States
Research Site
Mayfield Village, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Portland, Oregon, United States
Research Site
Erie, Pennsylvania, United States
Research Site
Greer, South Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Chesapeake, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Winnipeg, Manitoba, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Laval, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saint-Eustache, Quebec, Canada
Countries
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References
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Hobbs K, Deodhar A, Wang B, Bitman B, Nussbaum J, Chung J, Collier DH. Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etanercept in patients with moderately active rheumatoid arthritis despite DMARD therapy. Springerplus. 2015 Mar 5;4:113. doi: 10.1186/s40064-015-0895-9. eCollection 2015.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20070561
Identifier Type: -
Identifier Source: org_study_id
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