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

Sponsor
Celltrion
Study ID
NCT01534884
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.

Study Details

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.

Key Dates

Start date
Feb 29, 2012
Status verified
May 2015
Primary completion
Aug 31, 2013
Completion
Feb 28, 2014

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MabThera
    rituximab
  • Active Comparator: CT-P10
    rituximab

Primary Outcome Measure

PK in terms of Cmax [ Time Frame: Up to Week 24 ]

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