Clinical trial NCT02908217: Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
Official title: Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polymyalgia Rheumatica
Keywords: Polymyalgia Rheumatica
Tocilizumab
Glucocorticoid
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Roche Chugai
First posted: 2016-09-20
Enrollment: 113
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24).
timeFrame: From week 0 to week 24
Secondary outcomes:
measure: Proportion of patients with (PMR-AS>17) in both arm
timeFrame: From Week 24 to Week 32
measure: PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.
timeFrame: From inclusion to week 32
measure: Cumulative dosages of GCs at Week 32
timeFrame: Week 32
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hopital Nord service de rhumatologie-Franche Comté
city: Besançon
country: France
facility: CIC Besançon
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHRU Brest
city: Corbeil Essonnes
country: France
facility: Centre hospitalier Sud-Francilien
city: Dijon
country: France
facility: CHU Dijon
city: Le Mans
country: France
facility: CH Le Mans
city: Marseille
country: France
facility: Hôpital européen
city: Morlaix
country: France
facility: Ch Des Pays de Morlaix
city: Mulhouse
country: France
facility: CH Mulhouse
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: hôpital Sapêtrière -APHP
city: Rennes
country: France
facility: CHU Rennes
city: St Etienne
country: France
facility: CHU St Etienne
city: Strasbourg
country: France
facility: CHRU de Strasbourg
Study officials:
affiliation: CHRU de Brest
name: Valérie Devauchelle-Pensec, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, Richez C, Truchetet ME, Wendling D, Toussirot E, Perdriger A, Gottenberg JE, Felten R, Fautrel BJ, Chiche L, Hilliquin P, Le Henaff C, Dervieux B, Direz G, Chary-Valckenaere I, Cornec D, Guellec D, Marhadour T, Nowak E, Saraux A. Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial. JAMA. 2022 Sep 20;328(11):1053-1062. doi: 10.1001/jama.2022.15459.