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

Polymyalgia Rheumatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908217
• Other study ID #: SEMAPHORE (RB15.210)
• Status: Completed
• Phase: Phase 3
• Start date: February 15, 2017
• Est. completion date: November 12, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 12, 2020
• Est. primary completion date: November 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

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.
• Placebo
6 Intravenous infusions of placebo every 4 weeks.

Locations

Country	Name	City	State
France	Hopital Nord service de rhumatologie-Franche Comté	Belfort
France	CHU Besançon	Besançon
France	CIC Besançon	Besançon
France	CHU Bordeaux	Bordeaux
France	CHRU Brest	Brest
France	Centre hospitalier Sud-Francilien	Corbeil Essonnes
France	CHU Dijon	Dijon
France	CH Le Mans	Le Mans
France	Hôpital européen	Marseille
France	Ch Des Pays de Morlaix	Morlaix
France	CH Mulhouse	Mulhouse
France	CHU de Nancy	Nancy
France	CHU Nantes	Nantes
France	hôpital Sapêtrière -APHP	Paris
France	CHU Rennes	Rennes
France	CHU St Etienne	St Etienne
France	CHRU de Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Roche Chugai

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low disease activity (PMR-AS<10) with steroid independence (GCs =5 mg absolute value) or decrease = 10 mg from week 0 to week 24).	PMR-AS measure	From week 0 to week 24
Secondary	Proportion of patients with (PMR-AS>17) in both arm	PMR-AS measure	From Week 24 to Week 32
Secondary	PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.	PMR-AS measure	From inclusion to week 32
Secondary	Cumulative dosages of GCs at Week 32	dosages of GCs	Week 32