A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT00965653
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is \< 50 individuals.

Key Dates

Start date
Aug 31, 2009
Status verified
Nov 2016
Completion
Jul 31, 2011

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Pharmacokinetics of TCZ after QW or Q2W sc administration [ Time Frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up ]

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