Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis (Triad RA)

Celltrion Healthcare

Status and phase

Completed

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Biological: rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01534884

CT-P10 1.1

2011-002822-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

154 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.