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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hanyang University Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Biological

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

Primary outcomes

PK in terms of Cmax

Time frame: Up to Week 24

maximum serum concentration

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Acronym: Triad RA

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Feb 17, 2012
Registry last updated: May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed