MedTrace Logo

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)

NCT03263715 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Polymyalgia Rheumatica

Interventions

DRUG

Tocilizumab Prefilled Syringe [Actemra]

Weekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16.

DRUG

Placebos

Weekly administration of Placebo subcutaneous from Baseline to Week 16.

DRUG

Glucocorticoids

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2020-06-02
Completion
2020-06-02

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263715 on ClinicalTrials.gov