Rheumatoid arthritis
Conditions
Interventions
Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Injection*
Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Injection*
Trade Na
Sponsors
Wyeth Pharmaceuticals France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has a diagnosis of RA based on the 1987 American College of Rheumatology (ACR) Revised Criteria for RA. 2. Subject is currently receiving an optimal dose of oral MTX once weekly for the treatment of RA, in the opinion of the investigator, but at least 15 mg/week but no more than 25 mg/week and at a stable dose for a minimum of 8 weeks at screening. 3. Subject has moderate RA disease activity, as defined by a DAS28 >3.2 and =5.1 at both the screening and baseline visits. 4. Subject has a functional status of class I, II, or III as defined by the ACR Revised Criteria. 5. Subject is 18 to 70 years of age at the time of consent. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has had previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF-a) inhibitors, or other biologic agents. 2. Subject has received any DMARD, other than MTX, within 28 days before baseline. 3. Subject has had concurrent treatment with more than 1 NSAID at screening. 4. Subject has had a dose of an NSAID that has changed within 14 days before screening. 5. Subject has had a dose of prednisone >10 mg/day (or equivalent) or has had a dose changed within 14 days before screening. 6. Subject has received an intra-articular, intravenous, intramuscular, or subcutaneous (SC) corticosteroid within 28 days before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of the combination of etanercept 50 mg once weekly plus MTX with that of MTX monotherapy at week 88 in subjects with moderate RA who have achieved low disease activity or remission after 36-week treatment with open-label etanercept 50 mg once weekly plus MTX. The conditional primary objective will be to compare the efficacy of the combination of etanercept 25 mg once weekly plus MTX with that of MTX monotherapy at week 88 in subjects with moderate RA who have achieved low disease activity or remission after 36-week treatment with open-label etanercept 50 mg once weekly plus MTX. The study hypothesis is that the combination of etanercept 50 mg once weekly plus MTX will be superior to MTX monotherapy, as determined by the proportion of subjects remaining in low disease activity or remission at week 88. The conditional hypothesis is that the combination of etanercept 25 mg once weekly plus MTX will be superior to MTX monotherapy.;Secondary Objective: To compare the efficacy of etanercept 50 mg once weekly plus MTX with etanercept 25 mg once weekly plus MTX at week 88 in subjects with moderate RA who have achieved low disease activity or remission after 36-week treatment with open-label etanercept 50 mg once weekly plus MTX. To assess the efficacy of etanercept 50 mg once weekly plus MTX over 36 weeks of the open-label period. To assess the safety of the treatment regimens over 36 weeks during the open-label period and 52 weeks of the double-blind period.;Primary end point(s): Proportion of subjects with DAS28 <3.2 at week 88 during period 2. | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed