Study to compare the safety and efficacy of etanercept of Intas Biopharmaceuticals Ltd against Enbrel® in patients with Active Rheumatoid Arthritis
- Conditions
- Health Condition 1: null- Active Rheumatoid Arthritis
- Registration Number
- CTRI/2013/09/003963
- Lead Sponsor
- Intas Biopharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients achieving a 20% ACR response rateTimepoint: at 12 weeks
- Secondary Outcome Measures
Name Time Method 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