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)

PHASE3CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

November 24, 2017

Primary Completion Date

June 2, 2020

Study Completion Date

June 2, 2020

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

Trial Locations (3)

1090

Allgemeines Krankenhaus der Stadt Wien, Vienna

1130

Krankenhaus Hietzing, 2. Medizinische Abteilung, Vienna

8036

Medizinische Universität Graz, Klinische Abteilung für Rheumatologie und Immunologie, Graz

All Listed Sponsors
lead

Medical University of Vienna

OTHER

NCT03263715 - 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) | Biotech Hunter | Biotech Hunter