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

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

Sponsors

Lead sponsor: University Hospital, Brest

Collaborator: Roche Chugai

Source 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.

Overall Status Active, not recruiting
Start Date February 15, 2017
Completion Date January 2022
Primary Completion Date August 31, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
Proportion of patients with (PMR-AS>17) in both arm From Week 24 to Week 32
PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17. From inclusion to week 32
Cumulative dosages of GCs at Week 32 Week 32
Enrollment 113
Condition
Intervention

Intervention type: Drug

Intervention name: Tocilizumab

Description: 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.

Arm group label: Tocilizumab

Other name: Intravenous infusions of tocilizumab

Intervention type: Drug

Intervention name: Placebo

Description: 6 Intravenous infusions of placebo every 4 weeks.

Arm group label: Placebo

Other name: Intravenous infusions of placebo

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

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Valérie Devauchelle-Pensec, Pr Principal Investigator CHRU de Brest
Location
facility
Hopital Nord service de rhumatologie-Franche Comté | Belfort, 90000, France
CIC Besançon | Besançon, 25000, France
CHU Besançon | Besançon, 25030, France
CHU Bordeaux | Bordeaux, 33076, France
CHRU Brest | Brest, 29200, France
Centre hospitalier Sud-Francilien | Corbeil Essonnes, 91106, France
CHU Dijon | Dijon, France
CH Le Mans | Le Mans, 72037, France
Hôpital européen | Marseille, 13003, France
Ch Des Pays de Morlaix | Morlaix, 29600, France
CH Mulhouse | Mulhouse, France
CHU de Nancy | Nancy, 54511, France
CHU Nantes | Nantes, 44093, France
hôpital Sapêtrière -APHP | Paris, 75013, France
CHU Rennes | Rennes, 35203, France
CHU St Etienne | St Etienne, France
CHRU de Strasbourg | Strasbourg, 67098, France
Location Countries

France

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Tocilizumab

Arm group type: Experimental

Description: 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.

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: 6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov