Clinical Trials Register

Summary
EudraCT Number:	2015-001275-50
Sponsor's Protocol Code Number:	IM101-550
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-05
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-001275-50

A.3

Full title of the trial

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive

Studio clinico di Fase 3B, randomizzato in doppio cieco per valutare l'efficacia e la sicurezza di abatacept SC in combinazione con metotressato verso metotressato in monoterapia nel raggiungere la remissione clinica in pazienti adulti con artrite reumatoide precoce mai trattati con metotressato.

A.3.1

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

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis.

Effetti di abatacept in pazienti ai quali ¿ stata recentemente diagnosticata l¿artrite reumatoide.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

IM101-550

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1168-2972

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	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GCT-SU
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	clinical.trials@bms.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	Abatacept
D.3.2	Product code	[BMS-188667]
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	ABATACEPT
D.3.9.1	CAS number	332348-12-6
D.3.9.2	Current sponsor code	BMS-188667
D.3.9.3	Other descriptive name	ND
D.3.9.4	EV Substance Code	SUB20635
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	125
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	proteina di fusione
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	Methotrexate Ebewe
D.2.1.1.2	Name of the Marketing Authorisation holder	Ebewe
D.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Methotrexate
D.3.2	Product code	[na]
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	METHOTREXATE
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	METHOTREXATE
D.3.9.4	EV Substance Code	SUB08856MIG
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	2
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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: 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	Methotrexate Ebewe
D.2.1.1.2	Name of the Marketing Authorisation holder	EBEWE Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	Methotrexate
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Capsule, hard
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	METOTREXATO
D.3.9.2	Current sponsor code	nd
D.3.9.3	Other descriptive name	METHOTREXATE
D.3.9.4	EV Substance Code	SUB08856MIG
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	2
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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
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, hard
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

Early Rheumatoid Arthritis

Artrite Reumatoide Precoce

E.1.1.1

Medical condition in easily understood language

Early Rheumatoid Arthritis

Artrite Reumatoide Precoce

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	23.1
E.1.2	Level	PT
E.1.2	Classification code	10039073
E.1.2	Term	Rheumatoid 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

The primary objective for this study is to compare the clinical efficacy of
weekly abatacept in combination with MTX to MTX alone in achieving
Remission, defined as SDAI = 3, at Week 24.

L'obiettivo primario di questo studio ¿ quello di confrontare l'efficacia clinica di abatacept settimanale in combinazione con MTX verso MTX da solo nel raggiungere la remissione, definita come SDAI = 3, alla settimana 24.

E.2.2

Secondary objectives of the trial

1) To compare the efficacy of weekly abatacept + MTX to MTX alone in
achieving remission by DAS28-CRP Remission criteria at Week 24.
2) To compare the efficacy of weekly abatacept + MTX to MTX alone in
achieving remission by SDAI remission criteria at Week 52.
3) To compare the efficacy of weekly abatacept + MTX to MTX alone in
reducing joint damage by X-ray at Week 52.
4) To compare the efficacy of weekly abatacept + MTX to MTX alone in
achieving remission by Boolean remission criteria at Week 52.

1) Confrontare l'efficacia di abatacept settimanale + MTX verso MTX da solo nel raggiungere la remissione in base a criteri di remissione DAS28 PCR alla settimana 24.
2) Confrontare l'efficacia di abatacept settimanale + MTX verso MTX da solo nel raggiungere la remissione in base a criteri di remissione DAS28 PCR alla settimana 52.
3) Confrontare l'efficacia di abatacept settimanale + MTX verso MTX da solo nel ridurre il danno articolare valutato radiograficamente alla settimana 52.
4) Confrontare l'efficacia di abatacept settimanale + MTX verso MTX da solo nel raggiungere la remissione in base ai criteri di remissione Boolean alla settimana 52.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: The MRI sub-study is presented in section 5.4.1.2 of the original IM101-550 protocol dated 08-MAY-2015.
MRI will be performed as a sub-study on about 80 subjects from selected qualified sites in selected countries. The purpose of this sub-study is to
further inform the mechanism of action and efficacy of abatacept in Early RA by obtaining sensitive imaging at early time-points prior to those when traditional x-ray imaging would be expected to demonstrate significant change due to disease.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Nella sezione 5.4.1.2 del protocollo IM101-550 datato 08-mag-2015 viene presentato il sotto-studio sulla RMN.

La RMN sar¿ eseguita nell'ambito di un sotto-studio su circa 80 soggetti selezionati in centri qualificati in altrettanti paesi selezionati (solo USA come specificato nel protocollo). Lo scopo di questo sotto-studio ¿ quello di avere ulteriori informazioni sul meccanismo d'azione e sull'efficacia di abatacept nell'artrite reumatoide precoce ottenendo immagini sensibili in momenti temporali anticipati rispetto a quando le immagini radiografiche tradizionali sarebbero in grado di dimostrare cambiamenti significativi legati alla malattia.

E.3

Principal inclusion criteria

a) Subjects have early RA, defined as diagnosis made by the ACR/EULAR
2010 criteria for the classification of RA within the past 6 months
b) Subjects must meet at least one of the following criteria:
i) CRP > 0.3mg/dL (ULN)
ii) ESR= 28mm/hr
c) Subjects have at least 3 tender joints and at least 3 swollen joints
using the 28 Joint Count Assessment at both screening and Day 1
(Appendix 11)
d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)
e) Subjects have an SDAI > 11

a) Soggetti con artrite reumatoide precoce, definite come diagnosi second i criteri ACR/EULAR 2010 per la classificazione di Artrite Reumatoide negli ultimi 6 mesi
b) Soggetti devono soddisfare almeno uno dei seguenti criteri:
i) CRP > 0.3mg/dL (ULN)
ii) ESR = 28mm/hr
c) I soggetti devono avere almeno 3 articolazioni dolenti e almeno 3 articolazioni tumefatte utilizzando la valutazione 28 Joint Count Assessment sia allo screening che al Giorno 1(Appendice 11)
d) I soggetti positivi per gli anticorpi proteina anti proteina citrullinate (ACPA)
e) Soggetti con un valore sulla scala SDAI > 11

E.4

Principal exclusion criteria

a) Subjects at risk for tuberculosis
b) Subjects with recent acute infection
c) Subjects with history of chronic or recurrent bacterial, viral or
systemic fungal infections.
d) Subjects who have present or previous malignancies, except
documented history of cured non-metastatic squamous or basal skin cell
carcinoma, or cervical carcinoma in situ
e) Creatinine clearance < 40 mL/min (Cockroft-Gault formula)

a) Soggetti a rischio di tuberculosi
b) Soggetti con infezione acuta recente
c) Soggetti con storia di infezioni batterica cronica o ricorrente, virale o fungina sistemica.
d) Soggetti che hanno tumori presenti o precedenti, ad eccezione di storia documentata di carcinoma a cellule squamose della pelle o basale non metastatico curato o carcinoma in situ della cervice.
e) Creatinina clearance < 40 mL/min (Formula di Cockroft-Gault)

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the proportion of subjects in SDAI Remission at Week 24.

L'endpoint primario di efficacia è la proporzione di soggetti in Remissione SDAI alla settimana 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Settimana 24

E.5.2

Secondary end point(s)

The secondary endpoints below will be assessed in the order below in a
hierarchical fashion after the primary endpoint is met to preserve the
type I error of the study at 5%
(1) Proportion of subjects in DA28-CRP Remission at Week 24
(2) Proportion of subjects in SDAI Remission at Week 52
(3) Mean change from baseline in TSS at Week 52
(4) Proportion of subjects in Boolean Remission at Week 52

Gli endpoint secondari di seguito verranno valutati nell'ordine seguente in modo gerarchico, dopo che l'endpoint primario viene soddisfatto per preservare l'errore di tipo I di studio al 5%

(1) Proporzione di soggetti in Remissione DA28-CRP alla Settimana 24
(2) Proporzione di soggetti in Remissione DA28-CRP alla Settimana 52
(3) Variazione media rispetto al basale in TSS alla Settimana 52
(4) Proporzione di soggetti in Remissione Boolean alla Settimana 52

E.5.2.1

Timepoint(s) of evaluation of this end point

(1) Week 24
(2) Week 52
(3) Week 52
(4) Week 52

(1) Settimana 24
(2) Settimana 52
(3) Settimana 52
(4) Settimana 52

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

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarkers

Biomarcatori

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)

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

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

Argentina

Australia

Austria

Brazil

Canada

Chile

Colombia

Czechia

Finland

France

Germany

Hungary

Israel

Italy

Japan

Korea, Democratic People's Republic of

Korea, Republic of

Mexico

Netherlands

Peru

Poland

Qatar

Romania

Russian Federation

Saudi Arabia

Singapore

South Africa

Spain

Sweden

Taiwan

United Arab Emirates

United Kingdom

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

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:

1350

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

580

F.4.2.2

In the whole clinical trial

1500

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)

At the end of the treatment periods, BMS will not continue to provide BMS supplied study drug to subjects/investigators unless BMS chooses
to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.

Al termine dei periodi di trattamento, BMS non continuer¿ a fornire BMS fornito farmaco in studio per soggetti / investigatori a meno che BMS scegliesse di estendere lo studio. Lo sperimentatore deve assicurare che il soggetto riceva adeguato standard di cura per trattare le sue condizioni in fase di studio.

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

2015-12-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-17

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

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