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Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis

NCT02087696 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2015-05-22

No results posted yet for this study

Summary

The purpose of this project is to evaluate the efficacy of Tocilizumab (TCZ) given as monotherapy in patients with active rheumatoid arthritis (RA) according to EULAR response at 24 weeks after treatment initiation.

The study design is an intervention study, uncontrolled, multicenter, prospective, 32-weeks, two cohorts of patients with poor compliance or with any contraindication or intolerance to methotrexate.

One cohort naive to previous biological therapy and the other one treated previously with a biological treatment.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Tocilizumab

Tocilizumab dose 8mg/kg administered every 4 weeks during 24 weeks.

Sponsors & Collaborators

  • Roche Farma, S.A

    collaborator INDUSTRY

  • Spanish Foundation of Rheumatology

    lead OTHER

Principal Investigators

  • Sara Marsal Barril, MD; PhD · Hospital Vall d'Hebron

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
2014-05-31
Primary Completion
2015-12-31
Completion
2016-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02087696 on ClinicalTrials.gov