<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03263715</url>
  </required_header>
  <id_info>
    <org_study_id>PMR-SPARE</org_study_id>
    <secondary_id>2016-004990-42</secondary_id>
    <nct_id>NCT03263715</nct_id>
  </id_info>
  <brief_title>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)</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared&#xD;
      with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind,&#xD;
      controlled fashion, focussing on glucocorticoid-free remission of disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background. Polymyalgia rheumatica is an inflammatory rheumatic disease of the elderly, with&#xD;
      a usually rapid response to intermediate-doses of glucocorticoids (GCs). In many patients,&#xD;
      relapses occur upon its dose reduction or cessation. Given the patients' age and the adverse&#xD;
      event profile of GCs, steroid- free remission is the most desired target in patients with&#xD;
      PMR, but typical GC sparing agents are often insufficient. Case series and small open studies&#xD;
      suggested an excellent effectiveness of tocilizumab, an inhibitor of the Interleukin&#xD;
      6-receptor.&#xD;
&#xD;
      Objective. To assess the efficacy and safety of a tocilizumab-based regimen compared with&#xD;
      placebo on top of rapidly tapered GC treatment in a double-blind, controlled fashion,&#xD;
      focussing on GC-free remission of disease.&#xD;
&#xD;
      Methods. In this double-blind, parallel group study, 32 patients with PMR will be recruited&#xD;
      from three rheumatology centres and will be randomised in a 1:1 ratio to tocilizumab or&#xD;
      placebo over the course of 16 weeks, accompanied by a rapid tapering GC scheme over 11 weeks&#xD;
      in both arms. The primary endpoint is GC-free remission at week 16, and follow-up will be&#xD;
      performed until week 24 for safety and sustained efficacy. Patients will receive either the&#xD;
      subcutaneous preparation of 162 mg tocilizumab weekly or matching placebo injections.&#xD;
&#xD;
      Expected Results. In case of a positive result of this study, the benefits for patients with&#xD;
      new-onset PMR will manifest in a reduction of the burden of GC intake in this elderly&#xD;
      population with increased risk of GC-related adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2017</start_date>
  <completion_date type="Actual">June 2, 2020</completion_date>
  <primary_completion_date type="Actual">June 2, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects in GC free remission at week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>Proportion of subjects in GC free remission at week 16</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative prednisone doses at weeks 12, 16 and 24</measure>
    <time_frame>Week 12, 16, 24</time_frame>
    <description>Cumulative prednisone doses at weeks 12, 16 and 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of flares per patient at weeks 12, 16 and 24</measure>
    <time_frame>Week 12, 16, 24</time_frame>
    <description>Number of flares per patient at weeks 12, 16 and 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first and second flare</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Time to first and second flare</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes including SF-36</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Patient reported outcomes including SF-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes including FACIT-Fatigue</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Patient reported outcomes including FACIT-Fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes including HAQ</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Patient reported outcomes including HAQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes including Patient Global Assessment of disease (PGA)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Patient reported outcomes including Patient Global Assessment of disease (PGA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes including Patient Assessment of pain</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Patient reported outcomes including Patient Assessment of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator reported outcomes including Evaluator Global Assessment of disease activity (EGA)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Investigator reported outcomes including Evaluator Global Assessment of disease activity (EGA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator reported outcomes including Duration and severity of Morning Stiffness</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Investigator reported outcomes including Duration and severity of Morning Stiffness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator reported outcomes including Elevation of upper limbs</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Investigator reported outcomes including Elevation of upper limbs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse events and serious adverse events, incidence of GC related adverse events, changes in vital signs, haematology and clinical chemistry parameters</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Occurrence of adverse events and serious adverse events, incidence of GC related adverse events, changes in vital signs, haematology and clinical chemistry parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with increased ESR (&gt;20mm/h) and CRP levels (&gt; 5mg/L) at week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Proportion of subjects with increased ESR (&gt;20mm/h) and CRP levels (&gt; 5mg/L) at week 24</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Polymyalgia Rheumatica</condition>
  <arm_group>
    <arm_group_label>Tocilizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tocilizumab-based regimen (Tocilizumab Prefilled Syringe [Actemra] 162 mg s.c. administered weekly) on top of rapidly tapered Glucocorticoid [Glucocorticoids]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo [Placebos] and rapidly tapered Glucocorticoid [Glucocorticoids] treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab Prefilled Syringe [Actemra]</intervention_name>
    <description>Weekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16.</description>
    <arm_group_label>Tocilizumab</arm_group_label>
    <other_name>Actemra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Weekly administration of Placebo subcutaneous from Baseline to Week 16.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucocorticoids</intervention_name>
    <description>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</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tocilizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of PMR as confirmed by the investigator at screening and at baseline,&#xD;
             fulfilment (also in retrospect) of the provisional 2012 ACR- EULAR classification&#xD;
             criteria&#xD;
&#xD;
          -  Diagnosis of PMR established at, or up to 2 weeks before the screening visit&#xD;
&#xD;
          -  GC naïve or on GC treatment for a maximum of 2 weeks at screening with an initial dose&#xD;
             between 12.5 and 25mg/day prednisone&#xD;
&#xD;
          -  Willing and able to receive oral prednisone 20mg/day at randomization and to follow a&#xD;
             pre-specified tapering regimen&#xD;
&#xD;
          -  Willing to receive treatment for prevention of GC-induced bone loss&#xD;
&#xD;
          -  No evidence of active infection with Mycobacterium tuberculosis (screening performed&#xD;
             according to national guidelines) and willing to take TB prophylaxis in case of&#xD;
             evidence of latent TB&#xD;
&#xD;
          -  Willing and being able to understand and follow the study procedures&#xD;
&#xD;
          -  Male and female subjects agreeing to conduct efficient contraception (unless they have&#xD;
             no childbearing potential)&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  Female and Male subjects from 18 years old and higher&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of GCA (cranial or large vessel) as indicated by unequivocal clinical&#xD;
             symptoms (except PMR), imaging and/or biopsy results. Routine screening of eligible&#xD;
             PMR patients for GCA with imaging methods or temporal artery biopsy is not recommended&#xD;
&#xD;
          -  GC treatment of PMR &gt;2 weeks&#xD;
&#xD;
          -  Conditions other than PMR requiring continuous or intermittent treatment with oral or&#xD;
             parenteral GCs or parenteral administration of GCs, unless the last exposure to GCs&#xD;
             was &gt;1 months before screening&#xD;
&#xD;
          -  Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)&#xD;
&#xD;
          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned&#xD;
             major surgery within 6 months following randomization&#xD;
&#xD;
          -  Treatment with any investigational agent within 4 weeks (or 5 half-lives of the&#xD;
             investigational drug, whichever is longer) of screening&#xD;
&#xD;
          -  Previous treatment with any cell-depleting therapies, including investigational agents&#xD;
             or approved therapies, some examples include: CAMPATH, anti-CD4, anti-CD5, anti-CD3,&#xD;
             anti-CD19 and anti-CD20&#xD;
&#xD;
          -  Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6&#xD;
             months of baseline&#xD;
&#xD;
          -  Immunization with a live/attenuated vaccine within 4 weeks prior to baseline&#xD;
&#xD;
          -  Previous treatment with Tocilizumab (an exception to this criterion may be granted for&#xD;
             single dose exposure upon application to the sponsor on a case-by-case basis)&#xD;
&#xD;
          -  Any previous treatment with alkylating agents such as chlorambucil, or with total&#xD;
             lymphoid irradiation&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions to human, humanized or murine&#xD;
             monoclonal antibodies&#xD;
&#xD;
          -  Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary&#xD;
             (including obstructive pulmonary disease), renal, hepatic, endocrine (include&#xD;
             uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated&#xD;
             diverticulitis, ulcerative colitis, or Crohn ́s disease)&#xD;
&#xD;
          -  Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT, AST, or&#xD;
             both &gt; 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin &gt; ULN&#xD;
&#xD;
          -  Serum creatinine &gt; 1.6 mg/dL (141 μmol/L) in female patients and &gt; 1.9 mg/dL (168&#xD;
             μmol/L) in male patients. Patients with serum creatinine values exceeding limits may&#xD;
             be eligible for the study, if their estimated glomerular filtration rates (GFR) are &gt;&#xD;
             30&#xD;
&#xD;
          -  Total Bilirubin &gt; ULN&#xD;
&#xD;
          -  Any history of recent serious bacterial, viral, fungal, or other opportunistic&#xD;
             infections&#xD;
&#xD;
          -  Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C&#xD;
&#xD;
          -  Positive QuantiFERON TB test, history of Tuberculosis, or active&#xD;
             Tuberculosis-infection, without at least 4 weeks of adequate therapy for Tuberculosis&#xD;
&#xD;
          -  Active infection with EBV as defined by EBV viral load &gt; 10,000 copies per mL of whole&#xD;
             blood&#xD;
&#xD;
          -  Any of the following hematologic abnormalities, confirmed by repeat tests:&#xD;
&#xD;
               1. White blood count &lt; 3,000/μL or &gt; 14,000/μL;&#xD;
&#xD;
               2. Lymphocyte count &lt; 500/ μL;&#xD;
&#xD;
               3. Platelet count &lt; 100,000/μL;&#xD;
&#xD;
               4. Hemoglobin &lt; 8.0 g/dL; or&#xD;
&#xD;
               5. Neutrophil count &lt; 2,000 cells/μL&#xD;
&#xD;
          -  Any major episode of infection requiring hospitalization or treatment with IV&#xD;
             antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to&#xD;
             screening&#xD;
&#xD;
          -  Primary or secondary immunodeficiency (history of or currently active) unless related&#xD;
             to primary disease under investigation&#xD;
&#xD;
          -  Any medical or psychological condition that in the opinion of the Principal&#xD;
             Investigator would interfere with safe completion of the trial&#xD;
&#xD;
          -  History of other malignancy within 5 years prior to screening, except for&#xD;
             appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or&#xD;
             Stage I uterine cancer&#xD;
&#xD;
          -  Pregnant women or nursing (breast feeding) mothers&#xD;
&#xD;
          -  Patients with reproductive potential not willing to use an effective method of&#xD;
             contraception&#xD;
&#xD;
          -  History of alcohol, drug or chemical abuse within 1 year prior to screening&#xD;
&#xD;
          -  Neuropathies or other conditions that might interfere with pain evaluation unless&#xD;
             related to primary disease under investigation&#xD;
&#xD;
          -  Patients with lack of peripheral venous access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medizinische Universität Graz, Klinische Abteilung für Rheumatologie und Immunologie</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allgemeines Krankenhaus der Stadt Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Hietzing, 2. Medizinische Abteilung</name>
      <address>
        <city>Wien</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Daniel Aletaha</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Polymyalgia Rheumatica</keyword>
  <keyword>Tocilizumab</keyword>
  <keyword>Glucocorticoid</keyword>
  <keyword>Glucocorticoid-Sparing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucocorticoids</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03263715
org study id: PMR-SPARE
secondary id: 2016-004990-42
nct id: NCT03263715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Background. Polymyalgia rheumatica is an inflammatory rheumatic disease of the elderly, with
      a usually rapid response to intermediate-doses of glucocorticoids (GCs). In many patients,
      relapses occur upon its dose reduction or cessation. Given the patients' age and the adverse
      event profile of GCs, steroid- free remission is the most desired target in patients with
      PMR, but typical GC sparing agents are often insufficient. Case series and small open studies
      suggested an excellent effectiveness of tocilizumab, an inhibitor of the Interleukin
      6-receptor.

      Objective. To assess the efficacy and safety of a tocilizumab-based regimen compared with
      placebo on top of rapidly tapered GC treatment in a double-blind, controlled fashion,
      focussing on GC-free remission of disease.

      Methods. In this double-blind, parallel group study, 32 patients with PMR will be recruited
      from three rheumatology centres and will be randomised in a 1:1 ratio to tocilizumab or
      placebo over the course of 16 weeks, accompanied by a rapid tapering GC scheme over 11 weeks
      in both arms. The primary endpoint is GC-free remission at week 16, and follow-up will be
      performed until week 24 for safety and sustained efficacy. Patients will receive either the
      subcutaneous preparation of 162 mg tocilizumab weekly or matching placebo injections.

      Expected Results. In case of a positive result of this study, the benefits for patients with
      new-onset PMR will manifest in a reduction of the burden of GC intake in this elderly
      population with increased risk of GC-related adverse events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of subjects in GC free remission at week 16
time frame: Week 16
description: Proportion of subjects in GC free remission at week 16
measure: Cumulative prednisone doses at weeks 12, 16 and 24
time frame: Week 12, 16, 24
description: Cumulative prednisone doses at weeks 12, 16 and 24
measure: Number of flares per patient at weeks 12, 16 and 24
time frame: Week 12, 16, 24
description: Number of flares per patient at weeks 12, 16 and 24
measure: Time to first and second flare
time frame: 24 Weeks
description: Time to first and second flare
measure: Patient reported outcomes including SF-36
time frame: 24 Weeks
description: Patient reported outcomes including SF-36
measure: Patient reported outcomes including FACIT-Fatigue
time frame: 24 Weeks
description: Patient reported outcomes including FACIT-Fatigue
measure: Patient reported outcomes including HAQ
time frame: 24 Weeks
description: Patient reported outcomes including HAQ
measure: Patient reported outcomes including Patient Global Assessment of disease (PGA)
time frame: 24 Weeks
description: Patient reported outcomes including Patient Global Assessment of disease (PGA)
measure: Patient reported outcomes including Patient Assessment of pain
time frame: 24 Weeks
description: Patient reported outcomes including Patient Assessment of pain
measure: Investigator reported outcomes including Evaluator Global Assessment of disease activity (EGA)
time frame: 24 Weeks
description: Investigator reported outcomes including Evaluator Global Assessment of disease activity (EGA)
measure: Investigator reported outcomes including Duration and severity of Morning Stiffness
time frame: 24 Weeks
description: Investigator reported outcomes including Duration and severity of Morning Stiffness
measure: Investigator reported outcomes including Elevation of upper limbs
time frame: 24 Weeks
description: Investigator reported outcomes including Elevation of upper limbs
measure: Occurrence of adverse events and serious adverse events, incidence of GC related adverse events, changes in vital signs, haematology and clinical chemistry parameters
time frame: 24 Weeks
description: Occurrence of adverse events and serious adverse events, incidence of GC related adverse events, changes in vital signs, haematology and clinical chemistry parameters
measure: Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 5mg/L) at week 24
time frame: Week 24
description: Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 5mg/L) at week 24
arm group label: Tocilizumab
arm group type: Experimental
description: Tocilizumab-based regimen (Tocilizumab Prefilled Syringe [Actemra] 162 mg s.c. administered weekly) on top of rapidly tapered Glucocorticoid [Glucocorticoids]
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo [Placebos] and rapidly tapered Glucocorticoid [Glucocorticoids] treatment
intervention type: Drug
intervention name: Tocilizumab Prefilled Syringe [Actemra]
description: Weekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16.
arm group label: Tocilizumab
other name: Actemra
intervention type: Drug
intervention name: Placebos
description: Weekly administration of Placebo subcutaneous from Baseline to Week 16.
arm group label: Placebo
intervention type: Drug
intervention name: Glucocorticoids
description: 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
arm group label: Placebo
arm group label: Tocilizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Daniel Aletaha
investigator title: Principal Investigator
mesh term: Polymyalgia Rheumatica
mesh term: Giant Cell Arteritis
mesh term: Glucocorticoids