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

Sponsor
Spanish Foundation of Rheumatology
Study ID
NCT02087696
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2014
Status verified
May 2015
Primary completion
Dec 31, 2015
Completion
Jul 31, 2016

Study Design

Enrollment
122 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Naive biological treatment
    Rheumatoid arthritis patients with intolerance or poor compliance or contraindication to methotrexate and who have not received previous biological treatment. Tocilizumab dose 8mg/kg administered every 4 weeks for 24 weeks
  • Other: Previous Biological treatment
    Rheumatoid arthritis patients with intolerance or poor compliance or contraindication to methotrexate and who have not received more than two previous biological treatments. Tocilizumab dose 8mg/kg administered every 4 weeks for 24 weeks

Primary Outcome Measure

Percentage of patients achieving good or moderate European League Against Rheumatism (EULAR) response. [ Time Frame: At 24 weeks of treatment. ]

Central Contacts

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