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To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

NCT ID: NCT01256736

Last Updated: 2013-11-20

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

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tocilizumab 8mg/kg + DMARDs

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks

DMARDs

Intervention Type DRUG

DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Interventions

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Tocilizumab

intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks

Intervention Type DRUG

DMARDs

DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
* Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
* Willing to give written informed consent


* History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
* ALT or AST \> ULNⅹ2.5
* Platelet count \< 100ⅹ103/ μL
* WBC \< 3,000/mm3
* Absolute neutrophil count \< 1,000/mm3
* Absolute lymphocyte count \< 500/mm3
* Total bilirubin \> ULNⅹ2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National Univ. Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.

Reference Type DERIVED
PMID: 32508063 (View on PubMed)

Other Identifiers

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CWP-TCZ302

Identifier Type: -

Identifier Source: org_study_id