CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 538 enrolled
Drug / intervention
Tocilizumabdrug
Likely dose
Tocilizumab 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00721123
NCT00721123Phase 3Completed

Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822

Hoffmann-La Roche·interventional·Posted Jul 23, 2008·Updated Nov 28, 2013

In Brief

A Phase 3 clinical trial evaluating Tocilizumab for Rheumatoid Arthritis. Completed, enrolled 538 participants across 69 sites in 17 countries.

Detailed Summary

This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Brazil, Bulgaria, Canada, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Singapore, Slovakia, Switzerland, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 23, 2008
Enrollment StartAug 1, 2005
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 17.9 years ago

Interventions

Tocilizumabdrug

Tocilizumab (myeloma receptor antibody \[MRA\]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.