CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,067 enrolled
Drug / intervention
Tocilizumab +3 moredrug
Likely dose
Tocilizumab 800 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/NCT00720798
NCT00720798Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Jul 23, 2008·Updated Sep 30, 2014

In Brief

A Phase 3 clinical trial evaluating Tocilizumab, Disease-modifying anti-rheumatic drugs, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 2,067 participants across 295 sites in 34 countries.

Detailed Summary

This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NCT00106574 \[Roche protocol WA18063\], and NCT00109408 \[Roche protocol WA17824\]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Costa Rica, Czechia, Denmark, Finland, France, Germany, Hong Kong, Iceland, Israel, Italy, Lithuania, Mexico, Netherlands, Norway, Panama, Peru, Portugal, Puerto Rico, Russia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 23, 2008
Enrollment StartSep 1, 2005
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 17.9 years ago

Interventions

Tocilizumabdrug

For participants weighing \> 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.

Disease-modifying anti-rheumatic drugsdrug

Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.

Non-steroidal anti-inflammatory drugsdrug

Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.

Oral corticosteroidsdrug

Oral corticosteroids (≤ 10 mg/day) were permitted during the study.