Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Arthritis And Arthritic Pain
Musculoskeletal Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: - Fulfill the 1987 American Rheumatism Association (ARA) criteria forRA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose ofup to 25 mg a week is permitted - Screening lab results must demonstrate:
AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greaterthan or equal to 8.5 g/dL;
Platelet count greater than or equal to 125,000/cm3;
White blood cell count (WBC) greater than or equal to 3500 cells/cm3;
Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedureis performed, the subject must provide informed consent for participation in the study
Exclusion
Exclusion Criteria: - Previous receipt of etanercept - Receipt of antibody to (tumornecrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currentlyenrolled in other investigational device or drug trials, or participation ininvestigational trial within the past 30 days - Receipt of intra-articularcorticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifyinganti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamidewithin 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day ofprednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidalanti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must notexceed the recommended dose in the product information sheet - Subject is not usingadequate contraception - Subject is pregnant or breast-feeding - Subject hassignificant concurrent medical disease