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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Celltrion
Sponsor:
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01534884
First received: February 8, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: rituximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Celltrion:

Primary Outcome Measures:
  • PK in terms of Cmax [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    maximum serum concentration


Estimated Enrollment: 147
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MabThera
rituximab
Biological: rituximab
1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.
Active Comparator: CT-P10
rituximab
Biological: rituximab
1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534884

Contacts
Contact: SunYoung Yu SunYoung.Yu@celltrion.com

Locations
Korea, Republic of
Hanyang University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: DaeHyun Yoo, M.D., Ph.D.         
Sponsors and Collaborators
Celltrion
Investigators
Study Director: DaeHyun Yoo, M.D., Ph.D. Hanyang University
  More Information

No publications provided

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01534884     History of Changes
Other Study ID Numbers: CT-P10 1.1, 2011-002822-37
Study First Received: February 8, 2012
Last Updated: July 21, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Celltrion:
RA, Biosimilar

Additional relevant MeSH terms:
Rituximab
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014