Clinical Trials Register

Summary
EudraCT Number:	2008-008934-35
Sponsor's Protocol Code Number:	ORDI-01
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:	2009-04-16
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

2008-008934-35

A.3

Full title of the trial

ENSAYO CLÍNICO ALEATORIZADO Y CONTROLADO PARA EVALUAR LA EFICACIA DE LA AZATIOPRINA VS. MICOFENOLATO SÓDICO PARA EL TRATAMIENTO DE LA FASE DE INDUCCIÓN Y MANTENIMIENTO DE LA REMISIÓN DE LOS BROTES EXTRA RENALES DEL LUPUS ERITEMATOSO SISTÉMICO.

A.4.1

Sponsor's protocol code number

ORDI-01

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dr Josep Ordi-Ros. Hospital Universitario Vall d'Hebron
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
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	IMUREL 50 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA, S.A.
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	AZATIOPRINA
D.3.9.1	CAS number	446-86-6
D.3.9.3	Other descriptive name	AZATHIOPRINE
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	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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	MYFORTIC 360 mg comprimidos gastrorresistentes recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS FARMACEUTICA, S.A.
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	MICOFENOLICO ACIDO
D.3.9.3	Other descriptive name	MYCOPHENOLIC ACID
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	360
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Lupus Eritematoso Sistémico

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9
E.1.2	Level	LLT
E.1.2	Classification code	10025139
E.1.2	Term	Lupus erythematosus systemic

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar la eficacia del tratamiento con micofenolato sódico en comparación con el tratamiento convencional con azatioprina para las manifestaciones extra-renales del Lupus Eritematoso Sistémico. Se definirá eficacia como la tasa de pacientes con respuesta clínica completa (si/no) en la semana 8 para los brotes leves/moderados y a la semana 12 en los brotes severos.
Remisión Completa se definirá como un SLEDAI ≤4 y/o ausencia de cualquier BILAG A o B

E.2.2

Secondary objectives of the trial

•Evaluar la disminución del número de brotes de la enfermedad durante la fase de seguimiento.
•Evaluar la reducción en el requerimiento de la dosis de corticoides orales a lo largo del tratamiento.
•Evaluar la mejoría en los parámetros inmunológicos como son una reducción en los títulos de anticuerpos anti-DNA y una normalización de los niveles de complemento.
•Evaluar las secuelas residuales debido a la enfermedad a lo largo del estudio mediante la escala de daño orgánico (SLICC).
•Evaluar el impacto del tratamiento en la calidad de vida del paciente y la satisfacción subjetiva de los pacientes, mediante la escala del SF-36.
•Evaluar la tolerabilidad y desarrollo de efectos secundarios por parte de ambos fármacos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.- Edad ≥18 años (18 – 65). Pacientes con menos de 18 años se incluirán con el consentimiento de un tutor
2.- Cumplir por lo menos 4 de los criterios diagnósticos del ACR (22) para el diagnóstico del LES (anexo 1)
3.- Cualquier brote extra-renal de la enfermedad con un SLEDAI ≥6 y/o con un BILAG A o 2 BILAG B que requiera para su control dosis adecuadas de antipalúdicos y ≥10 mg/día de prednisona o que requiera la introducción de un fármaco inmunosupresor debido a la severidad o al órgano implicado o por ser recidivante a pesar de un buen control inicial con la terapia antipalúdica y/o corticoide a dosis 10 mg/día

Se incluirán también pacientes que desarrollen manifestaciones hematológicas aisladas y/o pleuropericarditis recidivantes o que no se controlen con el tratamiento mencionado anteriormente aunque el SLEDAI ≤6

Los brotes se clasificarán como moderados y severos con la finalidad de definir el tratamiento a seguir. BROTE MODERADO: Se definirá como un brote con SLEDAI ≥6 pero ≤12. ROTE SEVERO: Se definirá como un Índice de SLEDAI≥12.
4.- Medicación estable en los 30 días previos en alguna de las siguientes medicaciones (sola o en combinación)

1.Corticosteroides a dosis >10 mg/día
2.Hidroxicloroquina a dosis de 400 mg/d

5.- En caso de mujeres, éstas no deben quedarse embarazadas y deben utilizar métodos de barrera como contracepción

E.4

Principal exclusion criteria

1.- Evidencia de un brote renal activo.
2.-Intolerancia o hipersensibilidad previa a uno de los dos principios
3.-Presencia de una infección activa.
4.-Niveles indosificables de TMPT (Tiometil purin transferasa).
5.-Embarazo
6.- Tratamiento con MMFs, azatioprina u otro inmunosupresor en los 2 meses previos al estudio.
7.- Brote de enfermedad severa que precise por criterio del médico responsable de otros tratamientos inmunosupresores de los que existe una mejor evidencia de eficacia
8.-Patología psiquiátrica o social concomitante que dificulte la colaboración y el seguimiento del paciente.
9.-Evidencia de una alteración analítica, en los 30 días antes de la inclusión en el estudio
. ALT o GPT >120 UI/mL
. Leucocitos <1000x106 no relacionado con el LES

10. Síntomas directamente relacionados a otras causas diferentes del LES como por ejemplo al síndrome antifosfolípido o evidencia de una enfermedad aguda o crónica no médicamente controlada, diferente del LES (ejemplo: enfermedad cardiopulmonar)

E.5 End points

E.5.1

Primary end point(s)

Evaluar la eficacia del tratamiento con micofenolato sódico en comparación con el tratamiento convencional con azatioprina para las manifestaciones extra-renales del Lupus Eritematoso Sistémico. La eficacia al tratamiento se basará en una mejoría en las escalas de actividad de la enfermedad (SLEDAI y BILAG) Se definirá eficacia como la tasa de pacientes con respuesta clínica completa (si/no) en la semana 8 para los brotes leves/moderados y a la semana 12 en los brotes severos. Remisión Completa se definirá como un SLEDAI ≤4 y/o ausencia de cualquier BILAG A o B.

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	240

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

2009-06-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-03-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-12-31

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