Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE
1 other identifier
interventional
113
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2017
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2020
CompletedDecember 4, 2020
December 1, 2020
3.7 years
September 16, 2016
December 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Tocilizumab
EXPERIMENTAL6 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
PLACEBO COMPARATOR6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
Interventions
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.
6 Intravenous infusions of placebo every 4 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Brestlead
- Roche Chugaicollaborator
Study Sites (17)
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
Saint-Etienne, France
CHRU de Strasbourg
Strasbourg, 67098, France
Related Publications (1)
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.
PMID: 36125471DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valérie Devauchelle-Pensec, Pr
CHRU de Brest
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2016
First Posted
September 20, 2016
Study Start
February 15, 2017
Primary Completion
November 12, 2020
Study Completion
November 12, 2020
Last Updated
December 4, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share