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

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ClinicalTrials.gov Identifier: NCT01534884
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: rituximab Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2012
Primary Completion Date : August 2013
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. PK in terms of Cmax [ Time Frame: Up to Week 24 ]
    maximum serum concentration


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534884


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01534884     History of Changes
Other Study ID Numbers: CT-P10 1.1
2011-002822-37 ( EudraCT Number )
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents