A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)

Sponsor
Medical University of Vienna
Study ID
NCT03263715
Phase
PHASE3
Status
Completed

Conditions

  • Polymyalgia Rheumatica

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab Prefilled Syringe [Actemra] — DRUG
    Weekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16.
  • Placebos — DRUG
    Weekly administration of Placebo subcutaneous from Baseline to Week 16.
  • Glucocorticoids — DRUG
    Rapidly tapered Glucocorticoid treatment. 20 mg/day of prednisone at randomization and a pre-specified taper regimen will be followed over 11 weeks: Week 0: 20 mg Week 1: 17,5 mg Week 2: 15 mg Week 3: 12,5 mg Week 4: 10 mg Week 5: 9 mg Week 6: 7 mg Week 7: 5 mg Week 8: 4 mg Week 9: 2 mg Week 10: 1 mg Week 11: 0 mg

Study Details

The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind, controlled fashion, focussing on glucocorticoid-free remission of disease.

Key Dates

Start date
Nov 24, 2017
Status verified
Jan 2021
Primary completion
Jun 2, 2020
Completion
Jun 2, 2020

Study Design

Enrollment
39 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Tocilizumab-based regimen (Tocilizumab Prefilled Syringe \[Actemra\] 162 mg s.c. administered weekly) on top of rapidly tapered Glucocorticoid \[Glucocorticoids\]
  • Placebo Comparator: Placebo
    Placebo \[Placebos\] and rapidly tapered Glucocorticoid \[Glucocorticoids\] treatment

Primary Outcome Measure

Proportion of subjects in GC free remission at week 16 [ Time Frame: Week 16 ]

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