Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis (Triad RA)
This study is ongoing, but not recruiting participants.
Sponsor:
Celltrion
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01534884
First received: February 8, 2012
Last updated: March 19, 2013
Last verified: March 2013
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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:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Rituximab
U.S. FDA Resources
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 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:
- 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.
Contacts and Locations 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: | March 19, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Celltrion:
|
RA, Biosimilar |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013