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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MabThera

rituximab

Group Type ACTIVE_COMPARATOR

rituximab

Intervention Type BIOLOGICAL

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

CT-P10

rituximab

Group Type ACTIVE_COMPARATOR

rituximab

Intervention Type BIOLOGICAL

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

Interventions

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rituximab

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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

1. Patient is unresponsive or intolerable to more than 2 biologic agents.
2. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
3. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No