Tocilizumab Effect iN pOlymyalgia Rheumatica
TENOR
Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)
1 other identifier
interventional
21
1 country
3
Brief Summary
Phase 1: Patients are treated with infusions of Tocilizumab (TCZ) for 3 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). At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12. Phase 2: All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3 months. Two arms are possible according to the PMR-AS. Either the classical GC treatment (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2012
3 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
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFebruary 11, 2015
January 1, 2015
2.3 years
September 17, 2012
February 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy at W12
PMR-AS at week 12
12 Weeks
Secondary Outcomes (1)
Safety and efficacy during the study
Week 2,4,8,12,16,20 and 24
Study Arms (1)
TCZ
EXPERIMENTALTocilizumab at week 0, week 4 and week 8 8mg/kg at each perfusion
Interventions
Eligibility Criteria
You may qualify if:
- Age between 50 years and 75 years included
- PMR-AS \> 10
- PMR according to the Chuang criteria
- Evolving since less than 12 months
- Without Horton disease
- Able to understand and accept the study
- Agree to sign the inform consent form
- Birth controlled during all the study and 6 months after
You may not qualify if:
- Disagree to participated
- Unable to understand the study
- Treated by GC at 0.3mg/kg/d in the past 7 days
- Less than 50 years old or more than 75 years old
- Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease
- Histories of important allergy
- Historically positive test or test positive at screening for HIV-1 antibody, hepatitis B surface antigen, or hepatitis C antibody.
- Abnormal screening blood test : leukocyte count less than 3.5 × 109 cells/L, neutrophil count less than 2 × 109 cells/L, hemoglobin level less than 85 g/L, platelet count less than 100 × 109 cells/L, or hepatic aminotransferase or alkaline phosphatase levels greater than 3 times the upper limit of normal
- Other inflammatory rheumatic disease or connective disease
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR (eg. Cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases)
- Current drug or alcohol abuse
- Patients treated with an immunosuppressive agents in the past 4 weeks
- Live/attenuated vaccine in the past 4 weeks
- Clinical symptoms of giant cell arteritis
- History of infection or infestation in the past 3 months
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Brestlead
- Chugai Pharmaceuticalcollaborator
Study Sites (3)
CHR d'Orléans
Orléans, France, 45000, France
Brest University Hospital
Brest, 29609, France
Nantes University Hospital
Nantes, 44000, France
Related Publications (3)
Carvajal Alegria G, Garrigues F, Bettacchioli E, Loeuille D, Saraux A, Cornec D, Devauchelle-Pensec V, Renaudineau Y. Tocilizumab controls bone turnover in early polymyalgia rheumatica. Joint Bone Spine. 2021 May;88(3):105117. doi: 10.1016/j.jbspin.2020.105117. Epub 2020 Dec 7.
PMID: 33301930DERIVEDLaporte JP, Garrigues F, Huwart A, Jousse-Joulin S, Marhadour T, Guellec D, Cornec D, Devauchelle-Pensec V, Saraux A. Localized Myofascial Inflammation Revealed by Magnetic Resonance Imaging in Recent-onset Polymyalgia Rheumatica and Effect of Tocilizumab Therapy. J Rheumatol. 2019 Dec;46(12):1619-1626. doi: 10.3899/jrheum.180958. Epub 2019 Mar 15.
PMID: 30877202DERIVEDDevauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29.
PMID: 26929219DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valérie DEVAUCHELLE, Pr
CHRU de Brest
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2012
First Posted
October 25, 2012
Study Start
July 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 11, 2015
Record last verified: 2015-01