Safety and Efficacy of tocilizuMAb versus placebo in Polymyalgia rHeumatica with glucocORticoid dEpendence SEMAPHORE

Phase 1

• Conditions: Polymyalgia rHeumatica; MedDRA version: 19.0Level: PTClassification code 10036099Term: Polymyalgia rheumaticaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-005389-51-FR
• Lead Sponsor: CHRU DE BREST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-27
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

-Age older than 50 years
-Having previously
-Fulfilled the Chuang criteria
-Be successfully treated with GCs = 15mg (CRP = 10 mg/l or ESR = 20 mm before GCs treatment and < 10 mg/dl (or ESR < 20 mm/h) after)
- And currently
-Being treated with schedule close to the 2015 ACR/EULAR recommendation and Unable to taper GCs < 10mg
-PMR-AS > 10
-Absence of signs or symptoms of other musculoskeletal or connective tissue conditions
-Able to give informed consent
-Concomitant treatments with méthotrexate or hydroxychloroquine are permitted if stable dose since 3 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General 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

Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data:

Exclusions Related to Prior or Concomitant Therapy

-Previous treatment with cell-depleting therapies, including investigational agents, including
but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20
-Treatment with IV gamma globulin or plasmapheresis within 6 months of baseline
-Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation
-Previous treatment with TCZ
-Immunization with a live/attenuated vaccine within = 4 weeks prior to baseline
-Treatment with cyclosporine A, azathioprine, or MMF within 4 weeks of baseline
-Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of baseline
-Previous treatment with tofacitinib
-Treatment with cyclophosphamide within 6 months of baseline
Exclusions Related to General Safety

-History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone
-Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary
(including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled
diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries,
or gastrointestinal (GI) disease
-History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative
lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GI
conditions that might predispose a patient to perforations
-Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other
infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease,
hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
-Active TB requiring treatment within the previous 3 years Patients should be screened for latent TB and, if positive, treated according to local practice guidelines prior to initiating TCZ treatment. Patients treated for TB with no recurrence within 3 years and patients treated for latent TB within 3 years are eligible.
-Primary or secondary immunodeficiency (history of or currently active)
-Pregnant women and females who are breastfeeding
-Female of childbearing potential must have a negative serum pregnancy test within 28 days of randomization. Females of child-bearing potential may participate in this trial only if using a reliable means of contraception (e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD) during study treatment and for minimum of 3 months after last dose of TCZ.
-Males of reproductive potential who are not willing to use an effective method of
contraception, such as condom, sterilization, or true abstinence throughout study and for a
minim

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified