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Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02908217
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Roche Chugai
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.


Condition or disease Intervention/treatment Phase
Polymyalgia Rheumatica Drug: Tocilizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Experimental: Tocilizumab
6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks.
Drug: Tocilizumab
6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks.
Other Name: Intravenous infusions of tocilizumab

Placebo Comparator: Placebo
6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
Drug: Placebo
6 Intravenous infusions of placebo every 4 weeks.
Other Name: Intravenous infusions of placebo




Primary Outcome Measures :
  1. Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24). [ Time Frame: From week 0 to week 24 ]
    PMR-AS measure


Secondary Outcome Measures :
  1. Proportion of patients with (PMR-AS>17) in both arm [ Time Frame: From Week 24 to Week 32 ]
    PMR-AS measure

  2. PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17. [ Time Frame: From inclusion to week 32 ]
    PMR-AS measure

  3. Cumulative dosages of GCs at Week 32 [ Time Frame: Week 32 ]
    dosages of GCs



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age older than 50 years
  • Fulfilled the Chuang criteria
  • And currently:

    • PMR-AS> 10
    • Absence of signs or symptoms of other musculoskeletal or connective tissue conditions
  • Able to give informed consent
  • Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months.

Exclusion Criteria:

  • Clinical symptoms of giant cell arteritis
  • Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease
  • History of major organ or haematopoietic stem cell/marrow transplant
  • Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
  • Planned surgical procedure within 12 months after randomization.
  • History of malignant neoplasm within the last 5 years.
  • Current active infection
  • Patient with elevated ALT or AST> 5 ULN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908217


Locations
Show Show 17 study locations
Sponsors and Collaborators
University Hospital, Brest
Roche Chugai
Investigators
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Principal Investigator: Valérie Devauchelle-Pensec, Pr CHRU de Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02908217    
Other Study ID Numbers: SEMAPHORE (RB15.210)
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Polymyalgia Rheumatica
Tocilizumab
Glucocorticoid
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases