Clinical Trials Register

Summary
EudraCT Number:	2012-003223-38
Sponsor's Protocol Code Number:	B3281004
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-03-04
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

2012-003223-38

A.3

Full title of the trial

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS

ESTUDIO DE EXTENSIÓN PARA EVALUAR EL TRATAMIENTO CON PF-05280586 EN COMPARACIÓN CON RITUXIMAB EN SUJETOS CON ARTRITIS REUMATOIDE ACTIVA QUE HAN PARTICIPADO EN OTROS ENSAYOS CLÍNICOS CON PF-05280586

A.3.1

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

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

Estudio de extensión en Artritis Reumatoide para pacientes que han participado en otros ensayos con PF-05280586.

A.3.2

Name or abbreviated title of the trial where available

REFLECTIONS B328-04

A.4.1

Sponsor's protocol code number

B3281004

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01643928

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	Pfizer Inc., 235 East 42nd Street, New York, NY 10017
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., 235 East 42nd Street, New York, NY 10017
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
B.5.3.4	Country	United States
B.5.4	Telephone number	0018007181021
B.5.5	Fax number	0013037391119
B.5.6	E-mail	ClinicalTrials.govCallCenter@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	No
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.3.1	Product name	Rituximab-Pfizer
D.3.2	Product code	PF-05280586
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not Applicable
D.3.9.2	Current sponsor code	PF-05280586
D.3.9.3	Other descriptive name	Not Applicable
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Yes
D.3.11.13.1	Other medicinal product type	Biosimilar medicinal product
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	MabThera®
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.2	Current sponsor code	Not Applicable
D.3.9.3	Other descriptive name	Not Applicable
D.3.9.4	EV Substance Code	SUB12570MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Rituxan®
D.2.1.1.2	Name of the Marketing Authorisation holder	Genentech, Inc. (A Member of the Roche Group)
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.2	Current sponsor code	Not Applicable
D.3.9.3	Other descriptive name	Not Applicable
D.3.9.4	EV Substance Code	SUB12570MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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

RHEUMATOID ARTHRITIS

Artritis reumatoide

E.1.1.1

Medical condition in easily understood language

RHEUMATOID ARTHRITIS

Artritis reumatoide

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10003268
E.1.2	Term	Arthritis rheumatoid
E.1.2	System Organ Class	100000004859

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 provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab-Pfizer program.

To evaluate the overall safety, tolerability and immunogenicity of rituximab-Pfizer occurring after transition from a licensed rituximab product to rituximab-Pfizer.

To continue follow-up of biomarker and efficacy endpoints of interest in previous studies in the rituximab-Pfizer program contributing to this protocol.

Proporcionar un acceso continuo al tratamiento a los sujetos con artritis reumatoide activa que hayan participado durante al menos 16 semanas en otros estudios del programa de rituximab-Pfizer.

Evaluar la seguridad, tolerancia e inmunogenicidad general de rituximab-Pfizer después de pasar del producto de rituximab comercialmente autorizado a rituximab-Pfizer.

Continuar el seguimiento del biomarcador y los criterios de valoración de la eficacia de interés procedentes de estudios anteriores del programa de rituximab-Pfizer que contribuyen a este protocolo.

E.2.2

Secondary objectives of the trial

Not applicable

No Aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
2. Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.
3. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 12 months after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
4. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

Los sujetos deben cumplir todos los criterios de inclusión siguientes para poder participar en el estudio:

1.Sujetos que estén dispuestos y sean capaces de cumplir con las visitas programadas, el plan de tratamiento, los análisis de laboratorio y otros procedimientos del estudio.

2.Haber participado durante un mínimo de 16 semanas después de iniciar el último ciclo de tratamiento en un estudio anterior de artritis reumatoide del programa de rituximab-Pfizer en los últimos 2 meses.

3.Las mujeres y hombres en edad fértil deben acceder a utilizar un método anticonceptivo altamente eficaz a lo largo del estudio y durante, al menos, 12 meses después de la última dosis del tratamiento asignado. Un sujeto está en edad fértil si, a criterio del investigador, tiene la capacidad biológica de concebir hijos y es sexualmente activo.

4.Comprobante de un documento de consentimiento informado, firmado y fechado personalmente, que indique que el sujeto ha sido informado de todos los aspectos pertinentes del ensayo.

E.4

Principal exclusion criteria

Subjects presenting with any of the following will not be included in the study:
1. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
2. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for 12 months after last dose of investigational product. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
3. Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
4. Requirement for treatment during study with prohibited concomitant medications listed in Appendix 1.
5. Severe reaction to licensed rituximab product or rituximab-Pfizer (eg, anaphylaxis).
6. Serious adverse event that was assessed as related to study drug in the prior study.
7. Absolute neutrophil count (ANC) ? 1500 cells/mm^3. ANC may be repeated one time to establish eligibility.
8. IgG levels <300 mg/dL. IgG may be repeated one time to establish eligibility.
9. 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.

Los sujetos que presenten cualquiera de los siguientes aspectos no podrán ser incluidos en el estudio:

1.Sujetos que sean miembros del personal del centro de investigación o parientes de dichos miembros del personal del centro o sujetos que sean empleados de Pfizer involucrados directamente en la realización del estudio.
2.Mujeres embarazadas; mujeres en periodo de lactancia; mujeres y hombres en edad fértil que no utilicen un anticonceptivo de eficacia elevada o que no accedan a seguir utilizando un anticonceptivo altamente eficaz durante los 12 meses posteriores a la última dosis del producto en investigación. Las mujeres en edad fértil deben presentar una prueba de embarazo negativa antes de la inclusión en este estudio.
3.Haber iniciado un tratamiento con agentes en investigación u otros agentes biológicos (incluidos Rituxan y MabThera) desde su participación en un estudio anterior de artritis reumatoide en el programa de rituximab-Pfizer.
4.Necesidad de un tratamiento durante el estudio con medicamentos concomitantes prohibidos enumerados en el Apéndice 1.
5.Reacción grave al producto comercializado de rituximab o rituximab-Pfizer (por ejemplo, anafilaxia).
6.Acontecimiento adverso grave que se valoró como relacionado con el fármaco del estudio en el estudio anterior.
7.Recuento absoluto de neutrófilos (RAN) ?1.500 células/mm3. El RAN puede repetirse una vez para establecer la idoneidad.
8.Niveles de IgG <300 mg/dl. La IgG puede repetirse una vez para establecer la idoneidad.
9.Otros trastornos graves psiquiátricos o médicos, agudos o crónicos, u otras anomalías de laboratorio que puedan aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o que puedan interferir en la interpretación de los resultados del estudio y, a criterio del investigador, hicieran que el sujeto no fuese adecuado para la inclusión en este estudio.

E.5 End points

E.5.1

Primary end point(s)

? Type, incidence, severity, timing, seriousness and relatedness of adverse events and
laboratory abnormalities including those occurring after transition from a licensed
rituximab product to rituximab-Pfizer.
? Incidence of anti-drug antibodies (ADA), including neutralizing antibodies, and drug concentrations.
? CD19+ B-cell count.
? Serum biomarkers IgG, IgM, RF, anti-CCP and complement.
? Mean change from initial study baseline in DAS28-CRP, EULAR response, LDAS (? 3.2), and DAS-CRP remission (<2.6).
? ACR response, calculated from initial study baseline.
? Change from initial study baseline in individual components of ACR response.
? Outcome measure using HAQ-DI.

?Tipo, incidencia, intensidad, momento, gravedad y relación de los acontecimientos adversos y de las anomalías de laboratorio, incluyendo las que tengan lugar después del paso del producto de rituximab comercialmente autorizado a rituximab-Pfizer.
?Incidencia de los anticuerpos contra el fármaco (ADA, por sus siglas en inglés), incluyendo anticuerpos neutralizantes y concentraciones de fármacos.
?Recuento de los linfocitos B CD19+.
?Biomarcadores séricos IgG, IgM, FR, anti-PCC y complemento.
?Cambio medio desde el inicio del estudio en la DAS28-CRP, la respuesta EULAR, la LDAS (?3,2) y la remisión de la DAS-CRP (<2,6).
?Respuesta según el ACR, calculada desde el inicio del estudio.
?Cambio desde el inicio del estudio en los componentes individuales de la respuesta del ACR.
?Medida del resultado utilizando el HAQ-DI.

E.5.1.1

Timepoint(s) of evaluation of this end point

? Documentation of AEs - Each clinic visit, including follow-up.
? ADA and Drug Concentrations - Each course: Days 1, 15 ± 3, 85 ± 7 and 169 ± 7. Follow-up: every 3 months.
? CD19+ B-cell count - Each course: Days 1, 36 ± 7, 85 ± 7 and 169 ± 7 (except no Day 36 in 3rd course) and every 3 months during follow-up.
? Serum IgG, IgM - Screening (Days -28 to -1), Each course: Days 1, 169 ± 7 (except no Day 1 in 1st course).
? RF, anti-CCP and complement - Each course: Days 1 and 169 ± 7.
? HAQ-DI, DAS28-CRP and ACR response ? Each course: Days 1, 36 ± 7, 85 ± 7 and 169 ± 7 (except no Day 36 in 3rd course).

-Documentación de los AAS-cada visita clínica, incluido seguimiento.
- ADA y concentraciones de medicación - cada curso: días 1, 15 ± 3, 85 ± 7 y 169 ± 7. Seguimiento: cada 3 meses.
- CD19+ recuento de células B - cada curso: días 1, 36 ± 7, 85 ± 7 y 169 ± 7 (Excepto día 36 en 3er curso) y cada 3 meses durante el seguimiento.
IgG, IgM en suero - screening (días -28 a -1), cada curso: Días 1, 169 ± 7 (excepto día 1 en 1er curso).
? RF, anti-CCP y complemento - Cada curso: Días 1 y 169 ± 7.
? HAQ-DI, DAS28-CRP y respuesta ACR ? Cada curso: Días 1, 36 ± 7, 85 ± 7 y 169 ± 7 (excepto Día 36 en 3er curso).

E.5.2

Secondary end point(s)

Not applicable

No aplica

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

No aplica

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

E.6.4

Safety

Yes

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity:
- of treatment with rituximab-Pfizer
- after transitioning from Rituxan or MabThera to rituximab-Pfizer

Inmunogenicidad:
- del tratamiento con rituximab-Pfizer
- después de la transición de Rituxan o MabThera a rituximab-Pfizer

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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)

Yes

E.8.2.2

Placebo

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

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

Argentina

Brazil

Canada

Colombia

France

Germany

Israel

Italy

Mexico

Peru

Poland

Russian Federation

South Africa

Spain

Taiwan

United Kingdom

United States

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

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:

118

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.4.2.2

In the whole clinical trial

157

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)

Study drugs and the study defined medical care will only be given to the subjects during the study. In the event that the subjects experience adverse events (AEs) which require follow-up, appropriate medical care will be provided.

As per protocol, for AEs (serious/non-serious) with a causal relationship to the study drug, follow-up by the investigator is required until the event/sequelae resolve or stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.

Medicación y cuidado médico definidos para el estudio se proporcionaran únicamente durante la participación en el mismo. En caso de experimentar acontecimientos adversos (AAs) que requieran seguimiento, se proporcionará cuidado médico adecuado.
Por protocolo, para AAs con relación causal con la medicación del estudio, se requiere seguimiento hasta resolución o estabilización del acontecimiento/secuela a un nivel adecuado para el investigador, y Pfizer coincida con dicha evaluación

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

2013-02-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-15

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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Results Status:
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