Back to results

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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

rituximab

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, Biosimilar

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hanyang University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

MabThera

CT-P10

Arm Description

rituximab

Outcomes

Primary Outcome Measures

PK in terms of Cmax

maximum serum concentration

Secondary Outcome Measures

Full Information

NCT ID

NCT01534884

First Posted

February 8, 2012

Last Updated

May 20, 2015

Sponsor

Celltrion

1. Study Identification

Unique Protocol Identification Number

NCT01534884

Brief Title

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

Acronym

Triad RA

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 Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celltrion

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

RA, Biosimilar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MabThera

Arm Type

Active Comparator

Arm Description

rituximab

Arm Title

CT-P10

Arm Type

Active Comparator

Arm Description

rituximab

Intervention Type

Biological

Intervention Name(s)

rituximab

Intervention Description

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

Primary Outcome Measure Information:

Title

PK in terms of Cmax

Description

maximum serum concentration

Time Frame

Up to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

DaeHyun Yoo, M.D., Ph.D.

Organizational Affiliation

Hanyang University

Official's Role

Study Director

Facility Information:

Facility Name

Hanyang University Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

28612179

Citation

Yoo DH, Suh CH, Shim SC, Jeka S, Molina FFC, Hrycaj P, Wiland P, Lee EY, Medina-Rodriguez FG, Shesternya P, Radominski S, Stanislav M, Kovalenko V, Sheen DH, Myasoutova L, Lim MJ, Choe JY, Lee SJ, Lee SY, Kim SH, Park W. Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial. BioDrugs. 2017 Aug;31(4):357-367. doi: 10.1007/s40259-017-0232-7.

Results Reference

derived

PubMed Identifier

27624791

Citation

Yoo DH, Suh CH, Shim SC, Jeka S, Cons-Molina FF, Hrycaj P, Wiland P, Lee EY, Medina-Rodriguez FG, Shesternya P, Radominski S, Stanislav M, Kovalenko V, Sheen DH, Myasoutova L, Lim MJ, Choe JY, Lee SJ, Lee SY, Kwon TS, Park W. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Mar;76(3):566-570. doi: 10.1136/annrheumdis-2016-209540. Epub 2016 Sep 13.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs