Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis
Phase 1
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: rituximab
- Registration Number
- NCT01534884
- Lead Sponsor
- Celltrion
- Brief Summary
This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective, Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA concomitantly treated with MTX during the Core Study Period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
Inclusion Criteria
- Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1987) for at least 6 months prior to randomization.
- Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL or an ESR ≥28 mm/hour.
Exclusion Criteria
- Patient is unresponsive or intolerable to more than 2 biologic agents.
- Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
- Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MabThera rituximab rituximab CT-P10 rituximab rituximab
- Primary Outcome Measures
Name Time Method PK in terms of Cmax Up to Week 24 maximum serum concentration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of