Clinical trial NCT01313208: Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: RA
Enbrel
DMARD
Joint Count
Rheumatoid Arthritis
Etanercept
disease modifying anti-rheumatic drug
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving DAS28 Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
timeFrame: Baseline and Weeks 2, 4, 8, 16, 20 and 24
measure: Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
timeFrame: Baseline and Weeks 2, 4, 8, 16, 20 and 24
measure: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Percentage of Participants Achieving Count Remission at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving CDAI Remission at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Clinical Disease Activity Index (CDAI) Score at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving SDAI Remission at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Tender 28-Joint Count (TJC28) at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Swollen 28-Joint Count (SJC28) at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Patient Global Assessment of Joint Pain at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Patient's Global Assessment of Disease Activity at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Physician Global Assessment of Disease Activity at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: C-reactive Protein Levels at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Participant Assessment of Fatigue at Each Time Point
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
measure: Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point
timeFrame: Baseline and Weeks 4, 12 and 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Research Site
state: Alabama
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Encino
country: United States
facility: Research Site
state: California
city: Hemet
country: United States
facility: Research Site
state: California
city: Inglewood
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Murrieta
country: United States
facility: Research Site
state: California
city: Santa Maria
country: United States
facility: Research Site
state: California
city: Tustin
country: United States
facility: Research Site
state: California
city: Upland
country: United States
facility: Research Site
state: California
city: Victorville
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Sebring
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: St. Clair Shores
country: United States
facility: Research Site
state: Michigan
city: Bismarck
country: United States
facility: Research Site
state: North Dakota
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Mayfield Village
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Erie
country: United States
facility: Research Site
state: Pennsylvania
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Saint-Eustache
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.