A Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy ofTocilizumab as a Remission-Induction andGlucocorticoid-Sparing Regimen in Subjects withNew-Onset Polymyalgia Rheumatica (PMR-SPARE) - PMR-SPARE

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie0 sites36 target enrollmentAugust 21, 2017

ConditionsPolymyalgia rheumaticaPolymyalgia rheumatica is an inflammatory rheumatic disease that occurs primarily in the elderly with a peak incidence around 70 years of age. It is clinically characterized by shoulder girdle and hip pain and stiffness which impair raising arms and rising from a chair.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsRoActemra - Solution for injection in pre-filled syringe - TOCILIZUMAB 162 mg

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Polymyalgia rheumaticaPolymyalgia rheumatica is an inflammatory rheumatic disease that occurs primarily in the elderly with a peak incidence around 70 years of age. It is clinically characterized by shoulder girdle and hip pain and stiffness which impair raising arms and rising from a chair.
Sponsor: Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie
Enrollment: 36
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 21, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie

Eligibility Criteria

Inclusion Criteria

•Diagnosis of PMR as confirmed by the investigator at screening and at baseline, fulfilment (also in retrospect) of the provisional 2012 ACR\-EULAR classification criteria
•Diagnosis of PMR established at, or up to 2 weeks before the screening visit
•GC naïve or on GC treatment for a maximum of 2 weeks at screening with an initial dose between 12\.5 and 25mg/day prednisone
•Willing and able to receive oral prednisone 20mg/day at randomization and to follow a pre\-specified tapering regimen
•Willing to receive treatment for prevention of GC\-induced bone loss
•No evidence of active infection with Mycobacterium tuberculosis (screening performed according to national guidelines) and willing to take TB prophylaxis in case of evidence of latent TB
•Willing and being able to understand and follow the study procedures
•Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)
•Written informed consent.
•Female and Male subjects from 18 years old and higher

Exclusion Criteria

•Evidence of GCA (cranial or large vessel) as indicated by unequivocal clinical symptoms (except PMR), imaging and/or biopsy results. Routine screening of eligible PMR patients for GCA with imaging methods or temporal artery biopsy is not recommended
•GC treatment of PMR \>2 weeks
•Conditions other than PMR requiring continuous or intermittent treatment with oral or parenteral GCs or parenteral administration of GCs, unless the last exposure to GCs was \>1 months before screening
•Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
•Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
•Treatment with any investigational agent within 4 weeks (or 5 half\-lives of the investigational drug, whichever is longer) of screening
•Previous treatment with any cell\-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti\-CD4, anti\-CD5, anti\-CD3, anti\-CD19 and anti\-CD20
•Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline
•Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
•Previous treatment with Tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the sponsor on a case\-by\-case basis)