Clinical Trials Register

Summary
EudraCT Number:	2010-023802-10
Sponsor's Protocol Code Number:	B1801023
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-11-07
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

Netherlands - Competent Authority

A.2

EudraCT number

2010-023802-10

A.3

Full title of the trial

AN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014)

A.3.1

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

Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types
of Childhood Arthritis

A.3.2

Name or abbreviated title of the trial where available

Clipper 2

A.4.1

Sponsor's protocol code number

B1801023

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/241/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United States
B.1.3.4	Country	United States
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	Pfizer Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc
B.5.2	Functional name of contact point	Clinical Trials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 E 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017, USA
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 800 7181021
B.5.5	Fax number	+1 303 739 1119
B.5.6	E-mail	ClinicalTrials.govCallCentre@pfizer.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	ENBREL 25 mg/ml polvo y disolvente para solución inyectable para uso pediátrico
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER LTD.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Powder and solvent for suspension for injection
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	ETANERCEPT
D.3.9.1	CAS number	185243690
D.3.9.2	Current sponsor code	B1801023
D.3.9.3	Other descriptive name	ETANERCEPT
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	25
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)	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	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	ENBREL 50 mg solución inyectable en jeringas precargadas
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER LTD.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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
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	ETANERCEPT
D.3.9.1	CAS number	185243690
D.3.9.2	Current sponsor code	B1801023
D.3.9.3	Other descriptive name	ETANERCEPT
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	50
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)	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	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.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Oligoarticular juvenile idiopathic arthritis, enthesistis related arthritis, or psoriatic arthritis

ARTRITIS IDIOPÁTICA JUVENIL OLIGOARTICULAR EXTENDIDA, ARTRITIS ASOCIADA A ENTESITIS O ARTRITIS PSORIÁSICA

E.1.1.1

Medical condition in easily understood language

3 Sub-types of Childhood Arthritis (Extended Oligoarticular Arthritis,
Enthesitis-Related Arthritis, and Psoriatic Arthritis)

3 Subtipos de Artritis en la Infancia (Artritis Oligoarticular Extendida, Artritis asociada a Entesistis y Artritis Psoriásica

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	10059176
E.1.2	Term	Juvenile idiopathic arthritis
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 monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular JIA, ERA, or PsA.

Vigilar la incidencia de neoplasias malignas en niños y adolescentes con AIJ oligoarticular extendida, ARE o APs.

E.2.2

Secondary objectives of the trial

- To assess the long-term safety profile of etanercept;
- To evaluate the long-term effect of etanercept on clinical benefit and physical
function.
Exploratory Objectives
- To evaluate clinical benefit and physical function after withdrawal of etanercept;
- To evaluate effect of etanercept on clinical benefit and physical function after disease relapse.

- Evaluar el perfil de seguridad a largo plazo de etanercept.
- Evaluar el efecto a largo plazo de etanercept sobre el beneficio clínico y la función física.
Objetivos Exploratorios
- Evaluar el beneficio clínico y la función física tras la retirada de etanercept;
- Evaluar el efecto de etanercept sobre el beneficio clínico y la función física tras la recidiva de la enfermedad.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria for All Subjects at Baseline: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator?s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document (and assent document, as applicable) indicating that the subject (and/or a legal representative/guardian(s) as applicable according to subject age and local guidelines) has been informed of all pertinent aspects of the period of the study in which participation is being considered.
2. Subjects who are willing and able to comply with all applicable aspects of the period of the study in which participation is being considered, including scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Receipt of at least 1 dose of investigational product and participation for
approximately 96 weeks in study 0881A1-3338.
Additional Inclusion Criteria for Subjects Planning to Continue Investigational
Product in the Active Treatment Period
Subjects must meet the following additional inclusion criteria at the baseline visit to be eligible to continue investigational product in study B1801023:
1. Have completed approximately 96 weeks of investigational product in study 0881A1-3338 and, in the investigator?s judgment, is appropriate to continue treatment with etanercept.
2. Either the subject or an available adult must be capable (according to the investigator?s judgment) of reconstituting and administering injections of subcutaneous (SC) etanercept.
3. The subject, parent, or legal representative/guardian of the subject must be able to read and complete the protocol-specified efficacy assessments.
4. The first dose of investigational product in study B1801023 must be administered
within 6 weeks of receiving the last dose of investigational product in the study
0881A1-3338.
Additional Inclusion Criteria for Subjects Planning to Enter in the Withdrawal/Re-treatment Period
1. Evidence of a personally signed and dated informed consent document (and assent document, as applicable) indicating that the subject (and/or a legal
representative/guardian(s) as applicable according to subject age and local guidelines) has been informed of all aspects of the withdrawal/re-treatment period of the study. Only one informed consent document/assent will be signed and dated for the withdrawal/re-treatment period.
2. The subject is willing and able to comply with all applicable aspects of the withdrawal/re-treatment period of the study, including scheduled visits, treatment
plan, laboratory tests, and other study procedures.
3. The subject and/or the parent or legal representative/guardian of the subject must be able to provide contact information, including primary care physician or other treating physician.
4. For subjects entering directly into the withdrawal/re-treatment period, have completed approximately 96 weeks of investigational product in study 0881A1-3338.
5. For subjects entering directly into the withdrawal/re-treatment period, the baseline visit in study B1801023 must be completed within 14 days of the last dose of investigational product in study 0881A1-3338.
6. The subject has met the Wallace definition for clinically inactive disease for at least 6 months on investigational product (etanercept) or, in the investigator?s judgment, has had a good clinical response and would benefit from withdrawal from investigational product.
7. The subject, parent, or legal representative/guardian of the subject must be able to read and complete the protocol-specified efficacy assessments.
Additional Inclusion Criteria for Subjects Planning to Restart Investigational Product in the Re-treatment Period
1. Re-treatment with investigational product should be based on the investigator?s clinical judgment as long as all other inclusion/exclusion criteria for re-treatment period are met.
2. Either the subject or an available adult must be capable (according to the investigator?s judgment) of reconstituting and administering injections of subcutaneous (SC) etanercept.

Criterios de inclusión para todos los pacientes en la visita basal: Un miembro debidamente cualificado del equipo del estudio del investigador analizará y documentará la elegibilidad de los pacientes antes de su inclusión en el estudio. Los pacientes deberán cumplir todos los criterios de inclusión siguientes para poder participar en el estudio:
1. Existencia de un documento de consentimiento informado (y un documento de asentimiento, si procede), firmado y fechado personalmente, que indique que se ha informado al paciente (o a su representante legal, si procede según la edad del paciente y la normativa local) de todos los aspectos pertinentes del período del estudio para el cual se considere la participación.
2. Pacientes dispuestos a cumplir todos los aspectos aplicables del período del estudio para el que se considere la participación, como las visitas programadas, el plan de tratamiento, las evaluaciones analíticas y otros procedimientos del estudio, y capaces de hacerlo.
3. Recepción de al menos una dosis del producto en investigación y participación durante aproximadamente 96 semanas en el estudio 0881A1-3338.
4. El paciente y/o el progenitor o el representante/tutor legal del paciente deben proporcionar información de contacto, incluido el médico de atención primaria u otro médico encargado de su tratamiento.
Otros criterios de inclusión para los pacientes en los que esté previsto seguir con el producto en investigación en el período de tratamiento activo
Los pacientes deben cumplir los siguientes criterios de inclusión adicionales en la visita basal para poder continuar con el producto en investigación en el estudio B1801023:
1. Haber completado aproximadamente 96 semanas con el producto en investigación en el estudio 0881A1-3338 y cuando, en opinión del investigador, procede seguir con el tratamiento con etanercept.
2. El paciente o un adulto disponible deberán ser capaces (según el criterio del investigador) de reconstituir y administrar inyecciones de etanercept por vía subcutánea (SC).
3. El paciente, los padres o el representante/tutor legal del paciente deberán saber leer y completar las evaluaciones de eficacia especificadas en el protocolo.
4. La primera dosis de producto en investigación en el estudio B1801023 debe administrarse en las 6 semanas siguientes a la última dosis de producto en investigación en el estudio 0881A1-3338.
Otros criterios de inclusión para los pacientes en los que esté prevista su incorporación al período de retirada/retratamiento
1. Existencia de un documento de consentimiento informado (y un documento de asentimiento, si procede), firmado y fechado personalmente, que indique que se ha informado al paciente (o a su representante legal, si procede según la edad del paciente y la normativa local) de todos los aspectos del período de retirada/retratamiento del estudio. Se firmará y fechará sólo un documento de consentimiento/asentimiento para el período de retirada/retratamiento.
2. Paciente dispuesto a cumplir todos los aspectos aplicables del período de retirada/retratamiento del estudio, como las visitas programadas, el plan de tratamiento, las evaluaciones analíticas y otros procedimientos del estudio, y capaces de hacerlo.
3. El paciente y el progenitor o el representante/tutor legal del paciente deben proporcionar información de contacto, incluido el médico de atención primaria u otro médico encargado de su tratamiento.
4. Los pacientes que se incorporen directamente al período de retirada/retratamiento tendrán que haber completado aproximadamente 96 semanas de tratamiento con el producto en investigación en el estudio 0881A1-3338.
5. En los pacientes que se incorporen directamente al período de retirada/retratamiento, la visita basal del estudio B1801023 deberá realizarse en el plazo de 14 días tras la última dosis de producto en investigación en el estudio 0881A1-3338.
6. El paciente ha cumplido la definición de Wallace para la enfermedad clínicamente inactiva durante al menos 6 meses en tratamiento con el producto en investigación (etanercept) o, a juicio del investigador, presenta una buena respuesta clínica y puede beneficiarse de la retirada del producto en investigación.
7. El paciente, los padres o el representante/tutor legal del paciente deberán saber leer y completar las evaluaciones de eficacia especificadas en el protocolo.
Otros criterios de inclusión para los pacientes en los que esté previsto reanudar el producto en investigación en el período de retratamiento
1. El retratamiento con el producto en investigación debe basarse en el juicio clínico del investigador, siempre y cuando se cumplan todos los demás criterios de inclusión/exclusión para el período de retratamiento.
2. El paciente o un adulto disponible deberán ser capaces (según el criterio del investigador) de reconstituir y administrar inyecciones de etanercept por vía subcutánea (SC).

E.4

Principal exclusion criteria

Exclusion Criteria for All Subjects at Baseline: Subjects presenting with any of the following will not be included in the study:
1. Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.
Additional Exclusion Criteria for Subjects Planning to Continue Investigational
Product in the Active Treatment Period
Subjects who completed approximately 96 weeks of investigational product in study
0881A1-3338 and present with any of the following will not be allowed to continue
investigational product in study B1801023:
1. Withdrawal from investigational product in study 0881A1-3338 for any reason.
2. History of malignancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.
3. Participation in other clinical studies of investigational drugs or investigational
combinations of approved drugs between the week 96 visit in study 0881A1-3338 and the baseline visit in study B1801023 or during participation in the active treatment
period of study B1801023.
4. Pregnant or breastfeeding female subjects.
5. Receipt of any of the following between the week 96 visit in study 0881A1-3338 and the baseline visit in study B1801023:
- Any immunosuppressive biologic drugs, including but not limited to TNF
inhibitors (other than etanercept), abatacept, rituximab, anakinra and
tocilizumab;
- Immunosuppressive drugs (excluding corticosteroids) (eg, cyclophosphamide,
cyclosporine, azathioprine);
- Leflunomide;
- Use of more than 1 of the non-biologic DMARDs permitted in study 0881A1-3338 (ie, methotrexate, hydroxychloroquine, chloroquine, sulfasalazine) in subjects <18 years of age;
- Use of more than 2 of the non-biologic DMARDs permitted in study 0881A1-3338 (ie, methotrexate, hydroxychloroquine, chloroquine, sulfasalazine) or hydroxychloroquine and chloroquine taken at the same time in subjects >=18 years of age;
- Non-biologic DMARDs other than those permitted in study 0881A1-3338 (ie, methotrexate, hydroxychloroquine, chloroquine, sulfasalazine), or those not
listed under other exclusion criteria;
- Any live (attenuated) vaccines.
6. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
7. Signs and symptoms or suspicion of active tuberculosis.
Additional Exclusion Criteria for Subjects Planning to Enter in the Withdrawal/Re-treatment Period
1. Withdrawal from investigational product in study 0881A1-3338 for any reason.
2. Prior and/or current participation in the observational period of study B1801023.
3. Prior and/or current participation in the withdrawal/re-treatment period of study
B1801023.
Additional Exclusion Criteria for Subjects Planning to Restart Investigational
Product in the Re-treatment Period: Please, refer to the protocol for more detail.

Criterios de exclusión para todos los pacientes en la visita basal: No podrán participar en el estudio los pacientes que se encuentren en cualquiera de las circunstancias siguientes:
1. Sujetos que sean miembros del personal del centro de investigación o empleados de Pfizer directamente implicados en la realización del ensayo.
Otros criterios de exclusión para los pacientes en los que esté previsto seguir con el producto en investigación en el período de tratamiento activo: Los pacientes que completen aproximadamente 96 semanas de tratamiento con el producto en investigación en el estudio 0881A1-3338 y que presenten cualquiera de las circunstancias siguientes no podrán continuar recibiendo dicho producto en el estudio B1801023:
1. Suspensión del producto en investigación en el estudio 0881A1-3338 por cualquier motivo.
2. Antecedentes de neoplasia maligna distinta del carcinoma espinocelular, carcinoma basocelular o carcinoma del cuello uterino in situ.
3. Participación en otros estudios clínicos de fármacos en investigación o combinaciones en investigación de fármacos aprobados entre la visita de la semana 96 del estudio 0881A1-3338 y la visita basal en el estudio B1801023 o durante la participación en el período de tratamiento activo del estudio B1801023.
4. Mujeres embarazadas o lactantes.
5. Tratamiento con cualquiera de lo siguiente entre la visita de la semana 96 del estudio 0881A1-3338 y la visita basal del estudio B1801023:
- Cualquier fármaco biológico inmunodepresor, entre otros los inhibidores del TNF (excepto etanercept), abatacept, rituximab, anakinra y tocilizumab;
- Inmunodepresores (excepto corticosteroides) (por ejemplo, ciclofosfamida, ciclosporina o azatioprina);
- Leflunomida;
- Uso de más de uno de los FARME no biológicos permitidos en el estudio 0881A1-3338 (es decir, metotrexato, hidroxicloroquina, cloroquina o sulfasalazina) en pacientes < 18 años;
- Uso de más de dos de los FARME no biológicos permitidos en el estudio 0881A1-3338 (es decir, metotrexato, hidroxicloroquina, cloroquina o sulfasalazina) o hidroxicloroquina y cloroquina administradas al mismo tiempo en pacientes >= 18 años;
- FARME no biológicos distintos de los permitidos en el estudio 0881A1-3338 (es decir, metotrexato, hidroxicloroquina, cloroquina o sulfasalazina) o que no se mencionen en otros criterios de exclusión;
- Cualquier vacuna de microbios vivos (atenuados).
6. Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier anomalía analítica que aumente el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interfiera en la interpretación de los resultados del estudio y, en opinión del investigador, impida la participación en el mismo.
7. Signos y síntomas o sospecha de tuberculosis activa.
Otros criterios de exclusión para los pacientes en los que esté prevista su incorporación al período de retirada/retratamiento
1. Suspensión del producto en investigación en el estudio 0881A1-3338 por cualquier motivo.
2. Participación previa o actual en el período de observación del estudio B1801023.
3. Participación previa o actual en el período de retirada/retratamiento del estudio B1801023.
Otros criterios de exclusión para los pacientes en los que esté previsto reanudar el producto en investigación en el período de retratamiento: Por favor, refiéranse al protocolo para más dealle.

E.5 End points

E.5.1

Primary end point(s)

Occurrence of malignancy over the course of the study.

Aparición de una neoplasia maligna a lo largo del estudio.

E.5.1.1

Timepoint(s) of evaluation of this end point

At minimum every 2 years

Como mínimo cada 2 años

E.5.2

Secondary end point(s)

Secondary Endpoints for Subjects in the Observational Period
- Occurrence of serious adverse events, including serious infections;
- Occurrence of medically important infections (ie, an infection requiring
hospitalization and /or parenteral [intravenous (IV), intra-muscular (IM)]
anti-infective agents).
Secondary Endpoints for Subjects in the Active Treatment Period, and
Withdrawal/Re-treatment Period
- Occurrence of serious adverse events, including serious infections;
- Occurrence of medically important infections (ie, an infection requiring
hospitalization and /or parenteral [intravenous (IV), intra-muscular (IM)]
anti-infective agents);
- Occurrence of all adverse events, including infections, infections considered
preventable by vaccination, and injection site reactions;
- Occurrence of withdrawals from investigational product due to adverse events;
- Laboratory evaluations;
Growth parameters;
- Tanner Stage Assessment for selected subjects;
- ACR Pediatric 30, 50, 70, 90, and 100, defined as >= 30% (and 50%, 70%, 90%,
100%, respectively) improvement from baseline in at least 3 of the 6 following
variables, with no more than 1 of the remaining variables worsening by > 30 %:
- Physician?s Global Assessment (PGA) of Disease Activity on a 21-circle visual analogue scale (VAS);
- Patient/Parent Global Assessment on a 21-circle VAS;
- Childhood Health Assessment Questionnaire (CHAQ)/Health Assessment
Questionnaire (HAQ);
- Number of joints with active arthritis, defined as joints that are swollen or, in
the absence of swelling, joints with limited range of motion accompanied by
pain and/or tenderness;
- Number of joints with limited range of motion;
- Laboratory measure of inflammation, c-reactive protein (CRP);
- Individual components of the ACR Pediatric Assessments;
- Pain Assessment on a 21-circle VAS;
- Duration of morning stiffness in minutes
- Clinically inactive disease defined as follows per Wallace Criteria:12
- No joints with active arthritis (defined as joints that are swollen or, in the
absence of swelling, joints with limited range of motion accompanied by pain
and/or tenderness);
- No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy
attributable to JIA;
- No active uveitis;
- CRP level within normal limits in the laboratory where tested or, if elevated,
not attributable to JIA;
- PGA of disease activity score of best possible on the scale used;
- Duration of morning stiffness of <= 15 minutes;
- The Juvenile Arthritis Disease Activity Score (JADAS), using 4 components (PGA of Disease Activity, Patient/Parent Global Assessment, number of joints with active
arthritis and CRP).20
Additional Secondary Endpoints for ERA Subjects
- Overall Back Pain and Nocturnal Back Pain on a 100 mm VAS;
- Bath Ankylosing Spondylitis Metrology Index (BASMI) and its components
(Intermalleolar Distance, Cervical Rotation, Modified Schober?s Test, Lateral Flexion, and Tragus to Wall Distance).
Additional Secondary Endpoints for PsA Subjects
- Body Surface Area (BSA);
- PGA of Psoriasis.

Criterios de valoración secundarios para los pacientes en el periodo de observación
- Incidencia de acontecimientos adversos graves, incluyendo infecciones graves;
- Incidencia de las infecciones médicamente importantes (es decir, una infección que requiera hospitalización o antiinfecciosos por vía parenteral [intravenosos (IV) o intramusculares (IM)]).
Criterios de valoración secundarios para los pacientes en el período de tratamiento activo y el período de retirada/ retratamiento
- Incidencia de acontecimientos adversos graves, incluyendo infecciones graves;
- Incidencia de las infecciones médicamente importantes (es decir, una infección que requiera hospitalización o antiinfecciosos por vía parenteral [intravenosos (IV) o intramusculares (IM)]);
- Incidencia de todos los acontecimientos adversos, incluidas las infecciones consideradas evitables con vacunas, y las reacciones en el lugar de inyección;
- Incidencia de suspensiones del producto en investigación por acontecimientos adversos;
- Estudios analíticos;
- Parámetros del crecimiento;
- Evaluación del estadio de Tanner en determinados pacientes.
- ACR pediátrica 30, 50, 70, 90 y 100, definida como una mejoría >= 30% (y 50%, 70%, 90%, 100%, respectivamente) con respecto al valor basal de al menos 3 de las 6 variables siguientes, sin que haya un empeoramiento > 30% en más de 1 de las variables restantes:
- Evaluación global por el médico (PGA) de la actividad de la enfermedad en una escala analógica visual de 21 círculos (EAV);
- Evaluación global por el paciente/progenitor en una EAV de 21 círculos;
- Cuestionario de evaluación de la salud infantil (CHAQ)/Cuestionario de evaluación de la salud (HAQ);
- Número de articulaciones con artritis activa, definidas como articulaciones con hinchazón o, en ausencia de hinchazón, articulaciones con rango de movimientos limitado acompañado de dolor y/o sensibilidad;
- Número de articulaciones con rango de movimiento limitado;
- Medición analítica de la inflamación, proteína C-reactiva (CRP);
- Componentes individuales de la evaluación ACR pediátrica;
- Evaluación del dolor en una EAV de 21 círculos;
- Duración de la rigidez matutina en minutos;
- Enfermedad clínicamente inactiva definida del modo siguiente según los criterios de Wallace12:
- Ninguna articulación con artritis activa (definida como articulación con hinchazón o, en ausencia de hinchazón, articulación con rango de movimientos limitado acompañado de dolor y/o sensibilidad);
- Ausencia de fiebre, exantema, esplenomegalia o linfadenopatía generalizada atribuibles a la AIJ;
- Ausencia de uveítis activa;
- Valor de CRP dentro de los límites de referencia del laboratorio que realiza el análisis o, si está elevado, no atribuible a la AIJ;
- Puntuación de mejor posible en la evaluación global por el médico (PGA) de la actividad de la enfermedad en la escala usada;
- Duración de la rigidez matutina ? 15 minutos;
- Puntuación de la actividad de la enfermedad articular juvenil (JADAS) utilizando 4 componentes (PGA de la actividad de la enfermedad, evaluación global por el paciente/progenitor, número de articulaciones con artritis activa y CRP)20.
Criterios de valoración secundarios adicionales para los pacientes con ARE
- Dolor de espalda global y dolor de espalda nocturno en una EAV de 100 mm;
- Índice de metrología de Bath para la espondilitis anquilosante (BASMI) y sus componentes (distancia intermaleolar, rotación cervical, prueba de Schober modificada, flexión lateral y distancia trago-pared).
Criterios de valoración secundarios adicionales para los pacientes con APs
- Superficie corporal (BSA);
- PGA de la psoriasis.

E.5.2.1

Timepoint(s) of evaluation of this end point

At minimum every 2 years

Como mínimo cada 2 años

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Australia

Belgium

Colombia

Czech Republic

France

Germany

Hungary

Italy

Latvia

Lithuania

Mexico

Netherlands

Norway

Poland

Russian Federation

Serbia

Slovakia

Slovenia

Spain

E.8.7

Trial has a data monitoring committee

Yes

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

As per protocol

Según protocolo

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

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)

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subject, parent, or legally authorized representative/guardian of the
subject must be able to read and complete the protocol specified efficacy assessments.

Sujeto, padre o representante legal / tutor del sujeto deben ser capaces de comprender y completar las evaluaciones de eficacia específicas del protocolo.

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

109

F.4.2.2

In the whole clinical trial

123

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)

After subjects particpation in the trial, he/she will receive the normal standard of care for their disease.

Después de la participación de sujetos en el estudio, el/ella recibirá el cuidado normal de su enfermedad

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	No aplica
G.4.3.4	Network Country	Spain

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-02-04

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