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A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

NCT01034137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2016-07-11

Study results available
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Summary

This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.

Conditions

Interventions

DRUG

methotrexate

orally weekly in ascending dosages, starting at 10mg/week

DRUG

placebo MTX

orally weekly

DRUG

placebo TCZ

iv every 4 weeks

DRUG

tocilizumab [RoActemra/Actemra]

8mg/kg iv every 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Netherlands

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 NCT01034137 on ClinicalTrials.gov