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Long-Term Efficacy and Safety of CT-P10 in Patients With RA

NCT ID: NCT01873443

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-10-31

Brief Summary

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This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab, MTX, folic acid

Group Type EXPERIMENTAL

Rituximab, MTX, folic acid

Intervention Type DRUG

Rituximab IV 1000mg MTX 10\~25mg/week Folic acid at least 5mg/week

Interventions

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Rituximab, MTX, folic acid

Rituximab IV 1000mg MTX 10\~25mg/week Folic acid at least 5mg/week

Intervention Type DRUG

Other Intervention Names

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Rituximab=CT-P10

Eligibility Criteria

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Inclusion Criteria

* Patient has disease improvement (moderate or good response) according to Disease Activity Score using 28 joint counts (DAS28) during the last course of treatment in Study CT-P10 1.1.
* Patient has completed all of the scheduled visits in the Study CT-P10 1.1 Main Study Period, including the Core Study Period and/or Extension Study Period.

Exclusion Criteria

* Patient has been withdrawn from Study CT-P10 1.1 for any reason.
* Patient has, at the time of providing informed consent, any current medical issues such as serious adverse events (SAEs) or current or previous intolerance issues that mean continuation in this maintenance study could be detrimental to their health, in the opinion of the investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celltrion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DaeHyun Yoo, Ph.D

Role: STUDY_DIRECTOR

Hanyang University

Locations

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Inha University College of Medicine Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

References

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Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, Hrycaj P, Wiland P, Lee EY, Shesternya P, Kovalenko V, Myasoutova L, Stanislav M, Radominski S, Lim MJ, Choe JY, Lee SJ, Lee SY, Kim SH, Yoo DH. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis. BioDrugs. 2017 Aug;31(4):369-377. doi: 10.1007/s40259-017-0233-6.

Reference Type DERIVED
PMID: 28600696 (View on PubMed)

Other Identifiers

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2012-005502-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-P10 1.3

Identifier Type: -

Identifier Source: org_study_id