Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: etanercept (Drug); Placebo (Drug); DMARD Therapy (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
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).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12
Secondary outcome: Percentage of Participants Achieving DAS28 Remission at Week 12Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints Percentage of Participants Achieving DAS28 Remission at All Other Timepoints Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point Percentage of Participants Achieving Count Remission at Each Time Point Percentage of Participants Achieving CDAI Remission at Each Time Point Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point Clinical Disease Activity Index (CDAI) Score at Each Time Point Percentage of Participants Achieving SDAI Remission at Each Time Point Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point Tender 28-Joint Count (TJC28) at Each Time Point Swollen 28-Joint Count (SJC28) at Each Time Point Patient Global Assessment of Joint Pain at Each Time Point Patient's Global Assessment of Disease Activity at Each Time Point Physician Global Assessment of Disease Activity at Each Time Point Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point C-reactive Protein Levels at Each Time Point Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point Participant Assessment of Fatigue at Each Time Point Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Additional inclusion (exclusion) criteria may apply
Locations and Contacts
Research Site, Quebec G1V 3M7, Canada
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, Winnipeg, Manitoba R3A 1M3, Canada
Research Site, Frederick, Maryland 21702, United States
Research Site, Lansing, Michigan 48910, United States
Research Site, St. Clair Shores, Michigan 48081, United States
Research Site, St. John's, Newfoundland and Labrador A1C 5B8, Canada
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, Burlington, Ontario L7R 1E2, Canada
Research Site, Portland, Oregon 97239, United States
Research Site, Erie, Pennsylvania 16508, United States
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, Saint-Eustache, Quebec J7P 4J2, Canada
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
Additional Information
AmgenTrials clinical trials website
Related publications: Bitman B, Chung J, Collier D, Hobbs K, Nussbaum J, Wang B.Primary results from the Moderate RA study.Journal-001079;
Starting date: March 2011
Last updated: May 7, 2014
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