MedTrace Logo

Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate

NCT01245452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-10-31

No results posted yet for this study

Summary

To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to Methotrexate alone.

The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population and correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety profile of Tocilizumab.

Conditions

Interventions

DRUG

Tocilizumab

Tocilizumab (8 mg/kg monthly from week 0 to 20)

DRUG

Methotrexate

MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8

Sponsors & Collaborators

  • Patrick Durez

    lead OTHER

Principal Investigators

  • Patrick DUREZ, Md · Université Catholique de Louvain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Belgium

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 NCT01245452 on ClinicalTrials.gov