Clinical Trials Register

Summary
EudraCT Number:	2017-002989-42
Sponsor's Protocol Code Number:	EFC15160
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-11-16
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-002989-42

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with polymyalgia rheumatica

Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de sarilumab en pacientes con polimialgia reumática (PMR)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Evaluation of the Efficacy and Safety of Sarilumab in Patients with Polymyalgia Rheumatica

Evaluación de la eficacia y la seguridad de sarilumab en pacientes con polimialgia reumática (PMR)

A.4.1

Sponsor's protocol code number

EFC15160

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1201-0777

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sanofi-Aventis Recherche & Développement
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sanofi-Aventis Recherche & Développement
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	sanofi-aventis, s.a.
B.5.2	Functional name of contact point	Unidad Estudios Clínicos
B.5.3	Address:
B.5.3.1	Street Address	c/ Josep Pla 2, 4ª planta
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08019
B.5.3.4	Country	Spain
B.5.4	Telephone number	93 485 94 00
B.5.6	E-mail	es-unidadestudiosclinicos@sanofi.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Kevzara ®
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis Groupe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SARILUMAB
D.3.9.2	Current sponsor code	SAR153191
D.3.9.4	EV Substance Code	SUB177914
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Kevzara ®
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis Groupe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SARILUMAB
D.3.9.2	Current sponsor code	SAR153191
D.3.9.4	EV Substance Code	SUB177914
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cortancyl ® 5 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PREDNISONE
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cortancyl ® 1 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PREDNISONE
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cortancyl ® 1 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PREDNISONE
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Polymyalgia rheumatica

Polimialgia reumática

E.1.1.1

Medical condition in easily understood language

Polymyalgia rheumatica

Polimialgia reumática

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10036099
E.1.2	Term	Polymyalgia rheumatica
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen.

Evaluar la eficacia de KEVZARA® (sarilumab) en pacientes con polimialgia reumática (PMR) conforme a la proporción de pacientes con remisión mantenida para sarilumab con una pauta de disminución gradual de corticoesteroides (CS) en comparación con placebo con una pauta de disminución gradual de CS.

E.2.2

Secondary objectives of the trial

-To demonstrate the efficacy of sarilumab in patients with polymyalgia rheumatica compared to placebo, in combination with a CS taper with regards to:
-Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time.
-Cumulative CS (including prednisone) exposure.
-To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with PMR.
-To measure sarilumab serum concentrations in patients with PMR.
-To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.

- Demostrar la eficacia de sarilumab en pacientes con PMR en comparación con placebo en combinación con una disminución gradual de CS con respecto a:
Las respuestas clínicas (como los componentes de remisión mantenida, las tasas de remisión de la enfermedad, el tiempo hasta la primera exacerbación de la enfermedad) a lo largo del tiempo.
La exposición acumulada de corticoesteroides (incluida prednisona).
- Evaluar la seguridad (incluida la inmunogenicidad) y la tolerabilidad de sarilumab en pacientes con PMR.
- Medir las concentraciones de sarilumab en el suero de pacientes con PMR.
- Evaluar el efecto de sarilumab en la disminución de la toxicidad de glucocorticoides, medida por el compuesto del cuestionario del índice de toxicidad de glucocorticoides (glucocorticoid toxicity index, GTI).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Diagnosis of polymyaglia rheumatica (PMR) according to European League Against Rheumatism/American College of Rheumatology classification criteria.
-Patients must be on prednisone of at least 7.5 mg/day (or equivalent) and not exceeding 20 mg/day at screening and during the screening period.
-Patient is willing and able to take prednisone of 15 mg/day at randomization.
-Patients must have a history of being treated for at least 8 weeks with prednisone (≥10 mg/day or equivalent).
-Patient must have had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose that is ≥7.5 mg/day (or equivalent) within the past 12 Weeks prior to screening:
-Unequivocal symptoms of PMR flare include shoulder and/or hip girdle pain associated with inflammatory stiffness.
-Patients must have erythrocyte sedimentation rate ≥30 mm/hr and/or C-reactive protein ≥10 mg/L associated with PMR disease activity within 12 weeks prior to screening.

- Diagnóstico de polimialgia reumática (PMR) de acuerdo con los criterios de clasificación de la Liga europea contra el reumatismo/Colegio estadounidense de reumatología (EULAR/ACR).
- Los pacientes deben estar en tratamiento con prednisona de al menos 7,5 mg/día (o equivalente) y no exceder los 20 mg/día en la selección ni durante el periodo de selección.
- El paciente es capaz y está dispuesto a tomar 15 mg/día de prednisona en la aleatorización.
- Los pacientes deben tener un historial de haber sido tratados durante al menos 8 semanas con prednisona (≥10 mg/día o equivalente).
- El paciente debe haber sufrido al menos un episodio de reagudización de PMR inequívoca mientras intentaba disminuir gradualmente de una dosis ≥7,5 mg/día (o equivalente) en las 12 semanas anteriores a la selección: Los síntomas inequívocos de una reagudización de PMR incluyen dolor en la cintura escapular o pélvica asociado a rigidez inflamatoria.
- Los pacientes deben tener VSG ≥30 mm/hora y/o PCR ≥10 mg/l asociado a la actividad de la PMR en las 12 semanas anteriores a la selección.

E.4

Principal exclusion criteria

-Diagnosis of giant cell arteritis (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, extremity claudication, blurry or loss of vision, symptoms of stroke).
-Diagnosis of active fibromyalgia.
-Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis.
-Concurrent diagnosis of rhabdomyolysis or neuropathic muscular diseases.
-Inadequately treated hypothyroidism.
-Organ transplant recipient.
-Therapeutic failure including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist.
-Any prior (within the defined period below) or concurrent use of immunosuppressive therapies but not limited to any of the following:
-Janus kinase inhibitor within 4 weeks of baseline.
-Alkylating agents including cyclophosphamide within 6 months of baseline.
-Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level.
-Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever is longer.
-Abatacept within 8 weeks of baseline.
-Anakinra within 1 week of baseline.
-Cyclosporine, azathioprine or mycophenolate mofetil or leflunomide within 4 weeks of baseline.
-Unstable methotrexate (MTX) dose and/or MTX dose >15mg/week within 3 months of baseline.
-Concurrent use of systemic CS for conditions other than PMR.
-Pregnant or breastfeeding woman.
-Patients with active or untreated latent tuberculosis.
-Patients with history of invasive opportunistic infections.
-Patients with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.
-Patients with uncontrolled diabetes mellitus.
-Patients with non-healed or healing skin ulcers.
-Patients who received any live, attenuated vaccine within 3 months of baseline.
-Patients who are positive for hepatitis B, hepatitis C and/or HIV.
-Patients with a history of active or recurrent herpes zoster.
-Patients with a history of or prior articular or prosthetic joint infection.
-Prior or current history of malignancy.
-Patients who have had surgery within 4 weeks of screening or planned surgery during study.
-Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.

- El diagnóstico de la arteritis de células gigantes (ACG) (p. ej., cefalea localizada persistente o recurrente, sensibilidad a nivel de la arteria temporal o del cuero cabelludo, claudicación mandibular, claudicación de extremidades, visión borrosa o pérdida de visión, síntomas de accidente cerebrovascular).
- Diagnóstico simultáneo de fibromialgia activa.
- Artritis reumatoide simultánea u otro tipo de artritis inflamatoria u otras enfermedades del tejido conectivo, como lupus eritematoso sistémico, esclerodermia generalizada, vasculitis, miositis, enfermedad mixta del tejido conectivo y espondilitis anquilosante.
- Diagnóstico simultáneo de rabdomiolisis o enfermedades musculares neuropáticas.
- Hipotiroidismo tratado inadecuadamente.
- Receptor de trasplante de órganos.
- Fallo terapéutico, incluidos respuesta inadecuada o intolerancia, o contraindicación, a antagonista biológicos de la IL-6.
- Cualquier uso anterior (dentro del periodo de lavado farmacológico definido a continuación) o simultáneo de tratamientos inmunosupresores, incluidos los siguientes:
Inhibidor de quinasa de Janus (JAK) en las 4 semanas anteriores al inicio.
Agentes alquilantes, incluida la ciclofosfamida, en los 6 meses anteriores al inicio.
Agentes de supresión de células (p. ej., anti CD20) sin ninguna prueba de recuperación de células B al nivel basal.
Inhibidores del factor de necrosis tumoral (Tumor necrosis factor, TNF) en un plazo de 2 a 8 semanas (etanercept en el plazo de 2 semanas; infliximab, certolizumab, golimumab o adalimumab en el plazo de 8 semanas) o después de que hayan transcurrido, como mínimo, 5 semividas, lo que suponga más tiempo.
Abatacept en las 8 semanas anteriores al inicio.
Anakinra en la semana anterior al inicio.
Ciclosporina (CsA), azatioprina (AZA) o micofenolato mofetilo (MMF) o leflunomida en las 4 semanas anteriores al inicio.
- Dosis inestable de metotrexato (MTX) y/o dosis de MTX >15 mg/semana en los 3 meses anteriores al inicio.
- Uso simultáneo de CS sistémicos para enfermedades diferentes a la PMR.
- Indicios de enfermedad concomitante grave no controlada (p. ej., cardiovascular, respiratoria, hepática, renal, endocrina, etc.).
-Embarazada o mujer lactante.
- Pacientes con tuberculosis latente activa o no tratada.
- Pacientes con antecedentes de infecciones oportunistas invasivas.
- Pacientes con fiebre asociada a infección o infecciones crónicas, persistentes o recurrentes que requieren tratamiento activo.
- Pacientes con diabetes mellitus no controlada.
- Pacientes con úlceras cutáneas no cicatrizadas o curativas.
- Pacientes que recibieron cualquier vacuna atenuada en vivo dentro de los 3 meses de la línea base.
- Pacientes que son positivos para hepatitis B, hepatitis C y / o VIH.
- Pacientes con antecedentes de herpes zoster activo o recurrente.
- Pacientes con antecedentes de infección articular o protésica previa o antecedentes de esta.
- Previa o actual historia de malignidad.
- Pacientes que se han sometido a cirugía dentro de las 4 semanas posteriores a la detección o cirugía planeada durante el estudio.
- Pacientes con antecedentes de enfermedad inflamatoria intestinal o diverticulitis grave o perforación gastrointestinal previa.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients achieving sustained remission.

Proporción de pacientes que logra la remisión mantenida

E.5.1.1

Timepoint(s) of evaluation of this end point

At Week 52

En la semana 52

E.5.2

Secondary end point(s)

1. Components of sustained remission (composite measure): summary of the components of sustained remission composite measure at Week 52.
2. Cumulative corticosteroid dose: total cumulative corticosteroid (including prednisone) dose over 52 weeks.
3. Time to first polymyalgia rheumatica (PMR) flare: duration of first PMR flare from clinical remission up to Week 52.
4. Change in glucocoritcoid toxicity index: changes from baseline in the glucocoritcoid toxicity index and its components up to Week 52.
5. Adverse events: number of adverse events.
6. Pharmacokinetic: serum concentrations of sarilumab.

1. Componentes de la remisión sostenida (medida compuesta): resumen de los componentes de la medida compuesta de remisión sostenida en la semana 52.
2. Dosis acumulada de corticosteroides: dosis total acumulada de corticosteroides (incluida la prednisona) durante 52 semanas.
3. Tiempo hasta el primer brote de polimialgia reumática (PMR): duración del primer brote de PMR desde la remisión clínica hasta la semana 52.
4. Cambio en el índice de toxicidad de los glucocorticoides: cambios desde el inicio en el índice de toxicidad de los glucocorticoides y sus componentes hasta la semana 52.
5. Acontecimientos adversos: cantidad de Acontecimientos adversos.
6. Farmacocinética: concentraciones séricas de sarilumab.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. At Week 52
2. Up to Week 52
3. Up to Week 52
4. Up to Week 52
5. Up to Week 58
6. Up to Week 58

1. En la semana 52
2. Hasta la semana 52
3. Hasta la semana 52
4. Hasta la semana 52
5. Hasta la semana 58
6. Hasta la semana 58

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Belgium

Canada

Chile

Denmark

Estonia

France

Germany

Hungary

Israel

Italy

Netherlands

Russian Federation

Spain

Switzerland

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Última visita del último paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

125

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

375

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

255

F.4.2.2

In the whole clinical trial

500

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-11-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-16

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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