Clinical Trials Register

Summary
EudraCT Number:	2009-016008-22
Sponsor's Protocol Code Number:	M10-880
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:	2010-06-04
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2009-016008-22

A.3

Full title of the trial

Estudio multicéntrico sobre la eficacia y la seguridad del anticuerpo monoclonal humano anti-TNF Adalimumab en sujetos con uvéitis intermedia, uveítis posterior o panuveítis no infecciosa inactiva.

A.3.2

Name or abbreviated title of the trial where available

N/A

A.4.1

Sponsor's protocol code number

M10-880

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	Abbott GmbH & Co. KG
B.1.3.4	Country	Germany
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
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	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	HUMIRA 40 mg solución inyectable en jeringa precargada
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOTT LABORATORIES 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	Information not present in EudraCT
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	ADALIMUMAB
D.3.9.3	Other descriptive name	ADALIMUMAB
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	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)	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)	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	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
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
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Uvéitis intermedia, uveítis posterior o panuveítis no infecciosa inactiva.

Inactive non-infectious intermediate-, posterior-, or pan-uveitis.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10022557
E.1.2	Term	Intermediate uveitis

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10033687
E.1.2	Term	Panuveitis

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10036370
E.1.2	Term	Posterior uveitis

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo de este estudio es evaluar la eficacia y la seguridad de una dosis inicial de 80 mg de
adalimumab seguida de una dosis de 40 mg administrada cada dos semanas por vía subcutánea
(s.c.) a partir de la semana 1 en comparación con un placebo en sujetos con uveítis intermedia,
uveítis posterior o panuveítis no infecciosa inactiva.

E.2.2

Secondary objectives of the trial

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• El sujeto tiene una edad ≥ 18 años.
• El sujeto ha recibido un diagnóstico de uveítis intermedia, uveítis posterior o panuveítis no
infecciosa.
• El sujeto ha presentado enfermedad inactiva durante ≥ 90 días antes del momento basal,
según el criterio clínico del investigador y el cumplimiento de los 3 criterios siguientes en
ambos ojos en las visitas de selección y basal:
• El sujeto no presenta lesión vascular retiniana inflamatoria y/o coriorretiniana inflamatoria activa.
• El sujeto tiene un grado de células en la cámara anterior ≤ 0,5+ conforme a los criterios del SUN.
• El sujeto tiene un grado de opacidad del vítreo ≤ 0,5+ conforme a los criterios del NEI/SUN.
• El sujeto recibe prednisona 10 a 35 mg (o un corticosteroide equivalente) en el momento
basal y la dosis no se ha aumentado en los últimos 28 días ni se ha reducido en los últimos
14 días.
• El historial médico del sujeto tiene que reflejar un intento de supresión progresiva del
tratamiento con corticoides orales sin exacerbación de la enfermedad, y haber fracasado a
ese intento, durante los 18 meses anteriores a su participación..

E.4

Principal exclusion criteria

• Sujetos con uveítis anterior aislada.
• Sujetos con uveítis infecciosa confirmada o sospechada, por ejemplo, uveítis infecciosa
debida a tuberculosis, infección por CMV (citomegalovirus), Enfermedad de Lyme,
toxoplasmosis e infección por el VHS (virus del herpes simple).
• Sujetos con coroidopatía serpiginosa.
• Sujetos con opacidad corneal o del cristalino que impida la visualización del fondo del ojo o
que probablemente requiera cirugía de cataratas durante el estudio.
• Sujetos con una presión intraocular ≥ 25 mm Hg y que estén recibiendo ≥ 2 medicamentos
para el glaucoma o que presenten signos de lesión glaucomatosa del nervio óptico.
• Sujetos que tengan una mejor agudeza visual corregida (MAVC) inferior a 20/200
(logMAR de ETDRS > 1,0) en un ojo como mínimo.
• Sujetos con uveítis intermedia y síntomas o hallazgos en la IRM indicativos de una
enfermedad desmielinizante como la esclerosis múltiple. Todos los sujetos con uveítis
intermedia deberán haberse realizado una RM cerebral previa en el momento del
diagnóstico de la uveítis intermedia o con posterioridad.
• Sujetos que han recibido previamente tratamiento anti-TNF y con cualquier producto
biológico con una posible repercusión terapéutica sobre la uveítis no infecciosa.
• Sujetos que hayan recibido un implante de glucocorticosteroides (Retisert®).
• Sujetos que hayan recibido corticosteroides intraoculares o perioculares en los 90 días
previos a la visita basal.
• Sujetos con retinopatía diabética no proliferativa intensa o proliferativa.
• Sujetos con degeneración macular neovascular/húmeda relacionada con la edad.
• Sujetos con anomalías de la interfaz vitreorretiniana (p. ej., tracción vitreomacular,
membranas epirretinianas, etc.) que puedan causar lesión estructural macular independiente
del proceso inflamatorio.
• Sujetos con edema macular clínicamente importante a juicio del investigador.

E.5 End points

E.5.1

Primary end point(s)

El tiempo hasta el fracaso del tratamiento. Por favor, remítanse a la sección 5.3.3.1 del estudio para más información.

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

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

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.8.3

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

Information not present in EudraCT

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

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

The end-of-study is defined as the date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is later (refer section 13 of the protocol).

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	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)	Yes
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	25
F.4.2	For a multinational trial
F.4.2.1	In the EEA	105
F.4.2.2	In the whole clinical trial	250

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

2010-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-06-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-12-02

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials