CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 218 enrolled
Drug / intervention
Tocilizumabdrug
Likely dose
Tocilizumab 162 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/NCT01662063
NCT01662063Phase 3Completed

A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Genentech, Inc.·interventional·Posted Aug 10, 2012·Updated Oct 12, 2016

In Brief

A Phase 3 clinical trial evaluating Tocilizumab for Rheumatoid Arthritis. Completed, enrolled 218 participants across 79 sites in 2 countries.

Detailed Summary

This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2012
Enrollment StartAug 1, 2012
Primary CompletionApr 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.9 years ago

Interventions

Tocilizumabdrug

TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.