Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
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| ClinicalTrials.gov Identifier: NCT02908217 |
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Recruitment Status :
Completed
First Posted : September 20, 2016
Last Update Posted : December 4, 2020
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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 |
| 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 |
| Actual Primary Completion Date : | November 12, 2020 |
| Actual Study Completion Date : | November 12, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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Placebo Comparator: Placebo
6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
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Drug: Placebo
6 Intravenous infusions of placebo every 4 weeks.
Other Name: Intravenous infusions of placebo |
- 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
- Proportion of patients with (PMR-AS>17) in both arm [ Time Frame: From Week 24 to Week 32 ]PMR-AS measure
- PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17. [ Time Frame: From inclusion to week 32 ]PMR-AS measure
- Cumulative dosages of GCs at Week 32 [ Time Frame: Week 32 ]dosages of GCs
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age older than 50 years
- Fulfilled the Chuang criteria
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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
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
Show 17 study locations
| Principal Investigator: | Valérie Devauchelle-Pensec, Pr | CHRU de Brest |
| 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: | December 4, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Polymyalgia Rheumatica Tocilizumab Glucocorticoid |
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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 |