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

Phase 3

Completed

• Conditions: Polymyalgia Rheumatica
• Interventions: Drug: Placebo; Drug: Tocilizumab

• Registration Number: NCT02908217
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-20
• Study Start: 2017-02-15
• Primary Completion: 2020-11-12
• Study Completion: 2020-11-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
Tocilizumab	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Proportion of patients with (PMR-AS>17) in both arm	From Week 24 to Week 32	PMR-AS measure

Trial Locations

Locations (17)

CIC Besançon; 🇫🇷 Besançon, France

Centre hospitalier Sud-Francilien; 🇫🇷 Corbeil Essonnes, France

Hôpital européen; 🇫🇷 Marseille, France

Ch Des Pays de Morlaix; 🇫🇷 Morlaix, France

Hopital Nord service de rhumatologie-Franche Comté; 🇫🇷 Belfort, France

CHU Besançon; 🇫🇷 Besançon, France

CHU de Nancy; 🇫🇷 Nancy, France

CHRU Brest; 🇫🇷 Brest, France

CH Mulhouse; 🇫🇷 Mulhouse, France

CHU St Etienne; 🇫🇷 St Etienne, France

hôpital Sapêtrière -APHP; 🇫🇷 Paris, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CH Le Mans; 🇫🇷 Le Mans, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Nantes; 🇫🇷 Nantes, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CHU Rennes; 🇫🇷 Rennes, France