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Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation

NCT01120366 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2015-01-26

No results posted yet for this study

Summary

The objective of this study is to investigate the efficacy and safety of the humanized anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in combination therapy with methotrexate (MTX) in patients with an inadequate response to treatment with MTX.

Furthermore, in patients who have been able to achieve control of disease activity via the above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is restarted after disease recurrence.

Conditions

Interventions

DRUG

Tocilizumab plus methotrexate

Tocilizumab 8mg/kg 4weeks (i.v.) plus methotrexate up to 52weeks.The dosage of MTX will be fixed at least 24 weeks from the start of the study.

DRUG

Tocilizumab

tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.

Sponsors & Collaborators

  • SURPRISE Study Group

    lead NETWORK

Principal Investigators

  • Tsutomu Takeuchi · Keio University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120366 on ClinicalTrials.gov