A study to Evaluate effects of GP2013 drug, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis
Phase 2
Completed
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Registration Number
- CTRI/2011/06/001781
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Rheumatoid arthritis as defined by the 1987 ACR classification
2. Severe active seropositive disease
3. Inadequate response or intolerance to other DMARDs and anti-TNFs
4. Treatment with Methotrexate
Exclusion Criteria
1.Patients with systemic manifestations of rheumatoid arthritis
2.Female patients nursing
3.Women of childbearing potential unless using birth control
4. Active infection
5. Known immunodeficiency syndrome
6.Positive Hepatitis B surface antigen or antibodies to Hepatitis C
7.History of cancer
8.Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare pharmacokinetics (PK) of GP2013 and rituximab following IV infusion in patients with RATimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and efficacy of GP2013 and rituximab in subjects with RATimepoint: 1.5 years;Safety and tolerability of GP2013 and rituximab in patients with RATimepoint: 1.5 years