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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 12

Percentage 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

Page last updated: August 23, 2015

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