Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy
1 other identifier
interventional
210
2 countries
47
Brief Summary
This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 rheumatoid-arthritis
Started Mar 2011
47 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
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
June 17, 2014
CompletedFebruary 9, 2017
February 1, 2017
1.9 years
March 10, 2011
May 7, 2014
February 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12
Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 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 measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.
Week 12
Secondary Outcomes (41)
Percentage of Participants Achieving DAS28 Remission at Week 12
Week 12
Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Baseline and Weeks 2, 4, 8, 16, 20 and 24
Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Baseline and Weeks 2, 4, 8, 16, 20 and 24
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
- +36 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Administered by subcutaneous injection once weekly.
Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
Eligibility Criteria
You may qualify if:
- Male or female ≥18 and ≤80 years of age at time of screening
- 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
You may not qualify if:
- Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (47)
Research Site
Birmingham, Alabama, 35205, United States
Research Site
Tuscaloosa, Alabama, 35406, United States
Research Site
Peoria, Arizona, 85381, United States
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
Encino, California, 91436, United States
Research Site
Hemet, California, 92543, United States
Research Site
Inglewood, California, 90301, United States
Research Site
La Jolla, California, 92037, United States
Research Site
Murrieta, California, 92563, United States
Research Site
Santa Maria, California, 93454, United States
Research Site
Tustin, California, 92780, United States
Research Site
Upland, California, 91786, United States
Research Site
Victorville, California, 92395, United States
Research Site
Denver, Colorado, 80230, United States
Research Site
Jacksonville, Florida, 32209, United States
Research Site
Ocala, Florida, 34474, United States
Research Site
Sarasota, Florida, 34239, United States
Research Site
Sebring, Florida, 33870, United States
Research Site
Tampa, Florida, 33613, United States
Research Site
Atlanta, Georgia, 30342, United States
Research Site
Meridian, Idaho, 83642, United States
Research Site
Springfield, Illinois, 62704, United States
Research Site
Lexington, Kentucky, 40504, United States
Research Site
Frederick, Maryland, 21702, United States
Research Site
Lansing, Michigan, 48910, United States
Research Site
Saint Clair Shores, Michigan, 48081, United States
Research Site
Bismarck, North Dakota, 58501, United States
Research Site
Akron, Ohio, 44311, United States
Research Site
Mayfield Village, Ohio, 44143, United States
Research Site
Oklahoma City, Oklahoma, 73103, United States
Research Site
Oklahoma City, Oklahoma, 73109, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Erie, Pennsylvania, 16508, United States
Research Site
Greer, South Carolina, 29650, United States
Research Site
Dallas, Texas, 75231, United States
Research Site
San Antonio, Texas, 78232, United States
Research Site
Chesapeake, Virginia, 23320, United States
Research Site
Seattle, Washington, 98133, United States
Research Site
Winnipeg, Manitoba, R3A 1M3, Canada
Research Site
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Research Site
Burlington, Ontario, L7R 1E2, Canada
Research Site
Laval, Quebec, H7T 2P5, Canada
Research Site
Montreal, Quebec, H1T 2M4, Canada
Research Site
Montreal, Quebec, H2L 1S6, Canada
Research Site
Montreal, Quebec, H3Z 2Z3, Canada
Research Site
Québec, Quebec, G1V 3M7, Canada
Research Site
Saint-Eustache, Quebec, J7P 4J2, Canada
Related Publications (1)
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.
PMID: 25793152BACKGROUND
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2011
First Posted
March 11, 2011
Study Start
March 1, 2011
Primary Completion
February 1, 2013
Study Completion
May 1, 2013
Last Updated
February 9, 2017
Results First Posted
June 17, 2014
Record last verified: 2017-02