Moderate Rheumatoid Arthritis (RA) With Enbrel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01313208
First received: March 10, 2011
Last updated: January 6, 2014
Last verified: January 2014

March 10, 2011
January 6, 2014
March 2011
May 2013   (final data collection date for primary outcome measure)
To evaluate whether adding 50 mg etanercept per week to standard-of-care DMARD therapy in subjects with moderately active Rheumatoid Arthritis is superior in inducing very good control of disease compared with continued DMARD therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01313208 on ClinicalTrials.gov Archive Site
  • To evaluate the safety of adding 50 mg etanercept per week to standard-of-care DMARD therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the effect of adding 50 mg etanercept per week to standard-of-care DMARD therapy in subjects with moderately active rheumatoid arthritis on the following parameters: * disease activity measures * quality of life and health-related outcomes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Moderate Rheumatoid Arthritis (RA) With 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

This study is designed to evaluate the effectiveness of adding Etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in subjects with moderately active Rheumatoid Arthritis (RA).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: etanercept
50 mg subcutaneous injection once weekly.
  • Placebo Comparator: Placebo 50 mg
    Intervention: Drug: etanercept
  • Experimental: etanercept 50 mg
    Intervention: Drug: etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
July 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female ≥18 and ≤80 years of age at time of screening
  • Subject is 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
  • Subject has moderate rheumatoid arthritis during screening, as defined by a DAS28-CRP > 3.2 and ≤ 5.1
  • Subject has 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)
  • Subject must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine

Exclusion Criteria:

  • Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
  • Subject has Class IV rheumatoid arthritis according to ACR revised response criteria
  • Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
  • Subject has previously used more than one experimental biologic DMARD. Subject 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
  • Subject has 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 subject 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01313208
20070561
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP