NCT02087696

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

Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis and Candidates With a Biological Monotherapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Spanish Foundation of Rheumatology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tocilizumab	Tocilizumab dose 8mg/kg administered every 4 weeks during 24 weeks.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2016-07-01
• First posted: 2014-03-14
• Last updated: 2015-05-22

Locations

20 sites across 1 country: Spain