CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 91 enrolled
Drug / intervention
tocilizumab +3 morebiological
Likely dose
methotrexate 25 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/NCT01163747
NCT01163747Phase 4Completed
CompareCT.gov

A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Genentech, Inc.·interventional·Posted Jul 16, 2010·Updated Dec 7, 2012

In Brief

A Phase 4 clinical trial evaluating tocilizumab, methotrexate, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 91 participants across 47 sites.

Detailed Summary

This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2010
Enrollment StartSep 1, 2010
Primary CompletionDec 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.0 years ago

Interventions

tocilizumabbiological

Intravenous repeating dose

methotrexatedrug

A stable dose of between 7.5 and 25 mg/week, oral or parenteral.

23-Valent Pneumococcal Polysaccharide Vaccinebiological

Intramuscular or subcutaneous injection

Tetanus Toxoid Adsorbed Vaccinebiological

Intramuscular injection