Health Condition 1: null- Active Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Etanercept: 25 mg subcutaneous injection twice a week for 12 weeks
Control Intervention1: Enbrel®: 25 mg subcutaneous injection twice a week for 12 weeks
Sponsors
Intas Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients with active Rheumatoid Arthritis diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis Subjects with Global Functional Status Assessment - class I, II or III according to the revised criteria of the American College of Rheumatology (ACR)
Exclusion criteria
Exclusion criteria: 1. Previous treatment with DMARDs except methotrexate 2. Known hypersensitivity to etanercept or any of the components of study medication 3. Patients with history of tuberculosis in the past or having findings suggestive of active tuberculosis or latent tuberculosis 4. Pregnant or breast-feeding patients 5. History of blood dyscrasias 6. Patients with history of alcohol, drug or chemical abuse 7. Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, cancer, uncontrolled diabetes, neurologic or psychiatric disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving a 20% ACR response rateTimepoint: at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in DAS28 score and HAQ score from baselineTimepoint: at 12 weeks;Percentage of patients achieving a 50% ACR response rateTimepoint: at 12 weeks | — |
Countries
India
Contacts
Public ContactDr Naman Shah
Intas Biopharmaceuticals Limited
Outcome results
None listed