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A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

NCT00848120 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-08-03

Study results available
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Summary

This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

Interventions

DRUG

tocilizumab [RoActemra/Actemra]

8mg/kg iv every 4 weeks for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-02-13
Completion
2010-02-13

Countries

  • Philippines

Study Locations

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Entities

Diseases
Companies

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 NCT00848120 on ClinicalTrials.gov