CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 68 enrolled
Drug / intervention
methylprednisolone +1 moredrug
Likely dose
methylprednisolone 1 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/NCT01219933
NCT01219933Phase 4Completed

An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE)

Hoffmann-La Roche·interventional·Posted Oct 13, 2010·Updated Jan 19, 2015

In Brief

A Phase 4 clinical trial evaluating methylprednisolone and tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 68 participants across 16 sites.

Detailed Summary

This open-label, single-arm study will assess the use of glucocorticoids (GC) in daily clinical practice and will evaluate the dose reduction of glucocorticoids once low disease activity is achieved in patients with rheumatoid arthritis tre ated with GC and background RoActemra/Actemra (tocilizumab) 8mg/kg intravenously every 4 weeks. In the non-interventional phase, the use of GC in daily clinical Belgian practice will be evaluated and described. This period of maximum 6 mont hs will allow those patients to obtain the inclusion criteria for the secondary interventional phase. In the interventional phase, a systematic GC dose reductio n schedule will be evaluated in patients having achieved low disease activity wh ile receiving the same background therapy with RoActemra/Actemra 8 mg/kg. Methyl prednisolone will be given from a starting dose of \>/= 1 mg to \</=20 mg orally d aily and will be tapered down. The anticipated study duration is up to 13 months

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 13, 2010
Enrollment StartJan 1, 2011
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.7 years ago

Interventions

methylprednisolonedrug

starting dose \>/= 1 mg and \</= 20 mg orally daily, according to dose-reduction schedule

tocilizumab [RoActemra/Actemra]drug

background therapy: 8 mg/kg iv every 4 weeks