CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 133 enrolled
Drug / intervention
Tocilizumab +2 moredrug
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/NCT02046616
NCT02046616Phase 3Completed
CompareCT.gov

Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.

Hoffmann-La Roche·interventional·Posted Jan 28, 2014·Updated Apr 13, 2018

In Brief

A Phase 3 clinical trial evaluating Tocilizumab, Methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 133 participants across 27 sites in 4 countries.

Detailed Summary

This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesDenmark, Finland, Norway, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 28, 2014
Enrollment StartMay 28, 2014
Primary CompletionSep 13, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.4 years ago

Interventions

Tocilizumabdrug

Tocilizumab 162 mg will be administered subcutaneously QW.

Methotrexatedrug

Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

Non-Biologic DMARDsdrug

Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.