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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02908217

Enrollment

113

Registered

2016-09-20

Start date

2017-02-15

Completion date

2020-11-12

Last updated

2020-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polymyalgia Rheumatica

Keywords

Polymyalgia Rheumatica, Tocilizumab, Glucocorticoid

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.

Interventions

DRUGTocilizumab

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.

DRUGPlacebo

6 Intravenous infusions of placebo every 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24).	From week 0 to week 24	PMR-AS measure

Secondary

Measure	Time frame	Description
Proportion of patients with (PMR-AS>17) in both arm	From Week 24 to Week 32	PMR-AS measure
PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.	From inclusion to week 32	PMR-AS measure
Cumulative dosages of GCs at Week 32	Week 32	dosages of GCs

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026