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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.
Hanyang University Medical Center
Seoul, South Korea
PK in terms of Cmax
maximum serum concentration
Time frame: Up to Week 24
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