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A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

NCT00965653 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-11-02

No results posted yet for this study

Summary

This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is \< 50 individuals.

Conditions

Interventions

DRUG

folic acid

\>/= 5 mg po weekly

DRUG

methotrexate

7.5 - 25 mg weekly (oral or parenteral)

DRUG

tocilizumab [RoActemra/Actemra]

162 mg sc weekly (QW)for 12 weeks

DRUG

tocilizumab [RoActemra/Actemra]

162 mg sc every other week (Q2W) for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Completion
2011-07-31

Countries

  • Canada
  • New Zealand
  • Spain

Study Locations

More Related Trials

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 NCT00965653 on ClinicalTrials.gov