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Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

NCT ID: NCT01211834

Last Updated: 2010-11-03

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Placebo+DMARDs

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intravenously over 1 hour infusion every 4weeks

DMARDs

Intervention Type DRUG

Methotrexate(MTX) and/or 1 DMARDs

Interventions

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tocilizumab

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

Intervention Type DRUG

DMARDs

Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Intervention Type DRUG

Placebo

intravenously over 1 hour infusion every 4weeks

Intervention Type DRUG

DMARDs

Methotrexate(MTX) and/or 1 DMARDs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>= 18 years of age
* Active RA of \> 6monts duration
* Received permitted DMARDs each at a stable dose for at least 8 weeks

Exclusion Criteria

* Rheumatic autoimmune disease other than RA
* Significant systemic involvement secondary to RA
* ALT or AST \> ULNā…¹1.5
* Platelet count \< 100,000/mm3
* Hemoglobin \< 8.5 g/dL
* White blood cells \< 3,000/mm3
* Absolute neutrophil count \< 2,000/mm3
* Absolute lymphocyte count \< 500/mm3
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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Seoul National Univ. Hospital

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-TCZ301

Identifier Type: -

Identifier Source: org_study_id