Clinical Trials Register

Summary
EudraCT Number:	2020-000350-96
Sponsor's Protocol Code Number:	IM101-863
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-10-22
Trial 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

2020-000350-96

A.3

Full title of the trial

A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate

Studio randomizzato, testa a testa, in singolo cieco, per confrontare la risposta al trattamento con abatacept per via sottocutanea rispetto ad adalimumab sulla terapia di base con metotrexato in adulti affetti da artrite reumatoide sieropositiva precoce che presentano alleli di rischio HLA di classe II per l’“epitopo condiviso” e una risposta inadeguata al metotrexato

A.3.1

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

Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate

Efficacia di abatacept rispetto a adalimumab nell’artrite reumatoide precoce positiva agli autoanticorpi

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

IM101-863

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1247-1367

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	GSM-CT
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.5.6	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/infusion in pre-filled syringe
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.3.9.4	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	Fusion protein
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	Humira
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Deutschland GmbH & Co. KG
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	ADALIMUMAB
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
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.3.9.1	CAS number	331731-18-1
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20016
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	40
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	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

Artrite reumatoide

E.1.1.1

Medical condition in easily understood language

Rheumatoid Arthritis

Artrite reumatoide

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

To demonstrate the superiority in efficacy of abatacept compared with adalimumab, both on background MTX, in achieving clinical response (ACR50) at Week 24, in early, seropositive (RF+ and ACPA+) RA patients with the SE HLA Class II risk alleles (ie, SE+).

Dimostrare la superiorità in termini di efficacia di abatacept rispetto ad adalimumab, entrambi sulla terapia di base con MTX, nel raggiungimento della risposta clinica (ACR50) alla Settimana 24, in pazienti con AR precoce sieropositivi (RF+ e ACPA+) con alleli di rischio HLA di classe II SE (ovvero SE+).

E.2.2

Secondary objectives of the trial

To compare the efficacy of abatacept with adalimumab, both on background MTX in achieving:
- clinical remission criteria (DAS28-CRP remission) at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+).
- clinical response (ACR50) at Week 24 in the whole study population of early, seropositive RA patients.
- clinical remission criteria (CDAI remission) at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+).
- improvement in pain at Week 24 in early, seropositive RA patients with the SE HLA Class II risk alleles (ie, SE+).
To determine: - the efficacy over time by treatment in early, seropositive RA patients (SE+ subset and whole population).
- the improvement in health-related quality of life over time by treatment in early, seropositive RA patients (SE+ subset and whole population).

Confrontare l’efficacia di abatacept con adalimumab, entrambi sulla terapia di base con MTX, nel raggiungimento: dei criteri di remissione clinica (DAS28-CRP) alla Settimana 24 in pazienti con AR precoce sieropositivi con alleli di rischio HLA di classe II SE; della risposta clinica (ACR50) alla Settimana 24 nell’intera popolazione dello studio di pazienti con AR precoce sieropositiva; dei criteri di remissione clinica (CDAI) alla Settimana 24 in pazienti con AR precoce sieropositivi con alleli di rischio HLA di classe II SE; del miglioramento del dolore alla Settimana 24 in pazienti con AR precoce sieropositivi con alleli di rischio HLA di classe II SE.
Determinare: l’efficacia nel tempo in base al trattamento nei pazienti con AR precoce sieropositivi (sottogruppo SE+ e popolazione intera); il miglioramento della qualità della vita correlata alla salute nel tempo in base al trattamento nei pazienti con AR precoce sieropositivi (sottogruppo SE+ e popolazione intera).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Females, ages = 18 years or local age of majority.
- Males, ages = 18 years or local age of majority.
- Participants have early RA, defined as symptoms of RA that started =12 months prior to screening and satisfied the ACR/EULAR 2010 criteria for the classification of RA at some point during the 12-month period.
- Participants will have the HLA-DRB1 alleles genotyped during screening and will be identified as carrying at least 1 copy of the SE alleles or not. No greater than 25% of randomized participants may be SE negative.
- Participants must be naive to any targeted (biologic or nonbiologic) DMARDs, conventional synthetic DMARDs other than MTX, investigational therapies for RA.
- Participants must have been treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization.
- Participants have an anti-CCP-2 test that is > 3× ULN and are positive for RF according to central lab testing during screening.
- Participants must have at least a DAS28-CRP = 3.2 at screening.
- Participants must have currently at least 3 tender and at least 3 swollen joints (excluding distal interphalangeals) at screening and at randomization.

- Aritrite Reumatoide (AR) precoce, ovvero con sintomi di AR iniziati =12 mesi prima dello screening e che hanno soddisfatto i criteri dell’ American College of Rheumatology/European League Against Rheumatism (ACR / EULAR) 2010 per la classificazione della AR ad un certo punto durante i 12 mesi.
- “naive” a qualsiasi farmaco antireumatico modificante la malattia (DMARDs) mirato (biologico o non biologico), DMARD sintetici convenzionali diversi da MTX, terapie sperimentali per AR.
- I partecipanti devono essere stati trattati con MTX per almeno 12 settimane,
con una dose stabile di MTX orale o parenterale per almeno 4 settimane prima della randomizzazione.
- test Anti-cyclic citrullinated peptide-2 (anti-CCP-2) che è> 3 × il limite superiore della norma e positività per il Fattore Reumatoide (RF) in base ai test di laboratorio centrali durante lo screening.
- un punteggio di attività della malattia conteggio di 28 articolazioni calcolato utilizzando la proteina C-reattiva (DAS28-CRP) almeno = 3,2 allo screening.
- almeno 3 articolazioni fragili e 3 gonfieal momento dello screening e alla randomizzazione.

E.4

Principal exclusion criteria

- Women who are breastfeeding.
- Participants with autoimmune disease other than RA or currently active fibromyalgia.
- Prior history of or current inflammatory joint disease other than RA.
- Participants at risk for TB infection.
- Participants with recent acute infection. In the case of prior SARS-CoV-2 infection within 30 days prior to enrollment, symptoms must have completely resolved with no clinically significant sequelae that would indicate a higher risk of participation in the study.
- Participants with history of primary immunodeficiency.
- Participants who have received any live vaccines within 3 months of the study drug administration.
- Participants who have received live attenuated or replicationcompetent vector SARS-CoV-2 vaccines within 3 months of study enrollment.
- Participants for whom 5 or more joints cannot be assessed for tenderness or swelling (ie, due to surgery, fusion, amputation, etc).
- Participants who have had previous exposure to abatacept or adalimumab.
- Participants who have received an IM, IV, or intra-articular administration of a corticosteroid within 4 weeks prior to randomization.
- Hepatitis B surface antigen (HBsAg)-positive, or hepatitis B core antibody (HBcAb) positive participants with detectable hepatitis B viral deoxyribonucleic acid (DNA).
- Hepatitis C antibody (HcAb)-positive participants with detectable hepatitis C viral RNA.
- History of certain types of infections

Donne in allattamento.
- malattia autoimmune diversa dall'artrite reumatoide ( ad esempio psoriali, lupus sistemico eritematoso [LES], vasculite, spondiloartrite sieronegativa, malattia infiammatoria intestinale, sindrome di Sjogren) o fibromialgia attiva al momento.
- Anamnesi precedente o malattia infiammatoria articolare in corso diversa dall'artrite reumatoide (ad esempio artrite psoriasica, gotta, artrite reattiva, malattia di Lyme).
- rischio di infezione da tubercolosi.
- infezione acuta recente.
- storia di infezione batterica cronica o ricorrente (ad es.
Pielonefrite cronica, osteomielite, bronchiectasie)
- Storia di infezione di una protesi articolare o di un'articolazione artificiale
- Storia di infezioni fungine sistemiche (come istoplasmosi,
blastomicosi o coccidiomicosi)
- storia di immunodeficienza primaria.
- Evidenze cliniche in corso o storia di una malattia demielinizzante
- 5 o più articolazioni non possono essere valutate per fragilità o gonfiore

E.5 End points

E.5.1

Primary end point(s)

Proportion of SE+ participants meeting ACR50 response at Week 24

Percentuale di partecipanti SE+ che soddisfano la risposta ACR50 alla Settimana 24

E.5.1.1

Timepoint(s) of evaluation of this end point

At Week 24

Alla settimana 24

E.5.2

Secondary end point(s)

1. Proportion of SE+ participants achieving DAS28-CRP remission (DAS28-CRP < 2.6) at Week 24
2. Proportion of whole study population participants meeting ACR50 response at Week 24
3. Proportion of SE+ participants achieving CDAI remission (CDAI = 2.8) at Week 24
4. Mean change from baseline in SE+ participant-reported pain (VAS) at Week 24
5. Proportion of SE+ subset and whole population achieving ACR20/50/70 responses, DAS remission, CDAI remission, SDAI remission over the SBTP and OLTP; mean changes from baseline in DAS28-CRP, CDAI, SDAI over the SBTP and OLTP; mean changes from baseline in the 7 ACR core components over the SBTP and OLTP
6. Mean change from baseline in SF-36 in SE+ subset and whole population at Week 24 and Week 104 (4 physical and 4 mental subscales and the physical component and mental component summary)

1. Percentuale di partecipanti SE+ che raggiungono la remissione DAS28-CRP (DAS28-CRP <2,6) alla Settimana 24
2. Percentuale di partecipanti dell’intera popolazione dello studio che soddisfa la risposta ACR50 alla Settimana 24
3. Percentuale di partecipanti SE+ che raggiunge la remissione CDAI (CDAI =2,8) alla Settimana 24
4. Variazione media rispetto al basale del dolore riferito dal partecipante SE+ (VAS) alla Settimana 24
5. Percentuale del sottogruppo SE+ e della popolazione intera che ha ottenuto risposte ACR20/50/70, remissione DAS, remissione CDAI, remissione SDAI rispetto a SBTP e OLTP; variazioni medie rispetto al basale in DAS28-CRP, CDAI, SDAI rispetto a SBTP e OLTP; variazioni medie rispetto al basale nei 7 componenti principali ACR rispetto a SBTP e OLTP
6. Variazione media rispetto al basale nel Questionario sulla salute in forma breve a 36 voci (SF-36) nel sottogruppo SE+ e nell’intera popolazione alla Settimana 24 e alla Settimana 104 (4 sottoscale fisiche e 4 mentali e nella sintesi della componente fisica e della componente mentale)

E.5.2.1

Timepoint(s) of evaluation of this end point

1-4. At Week 24
5. Over the SBTP and OLTP
6. At Week 24 and Week 104

1-4. Alla settimana 24
5. rispetto a SBTP e OLTP
6. Alla settimana 24 e alla settimana 104

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

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)

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

Australia

Japan

Mexico

Taiwan

United States

France

Germany

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

United Kingdom

Czechia

Argentina

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

End of trial is defined as last visit for the last participant.

La conclusione della sperimentazione è definita come l’ultima visita dell’ultimo partecipante

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:

340

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

In situations where consent cannot be given by subjects/participants, their legally acceptable representatives (as per country guidelines) are clearly and fully informed regarding clinical studies in which the partecipant volunteers to partecipate.

Nelle circostanze in cui il consenso non può essere dato dai soggetti/partecipanti, i loro rappresentanti legali (come da linee guida del paese) vengono informati in modo chiaro e completo sugli studi clinici a cui il partecipante si offre a partecip

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

192

F.4.2.2

In the whole clinical trial

400

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 open-label treatment period, BMS will not continue to provide BMS-supplied study treatment to participants/investigators unless BMS chooses to extend the study. The investigator should ensure that the participant receives appropriate standard of care to treat the condition under study.

Alla fine del periodo di trattamento in aperto, BMS non continuerà a fornire il trattamento di studio ai partecipanti / sperimentatori a meno che BMS non scelga di estendere lo studio. Lo sperimentatore dovrebbe assicurarsi che il partecipante riceva un adeguato standard di cura per trattare la patologia in 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

2021-09-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-30

P. End of Trial
P.	End of Trial Status	Ongoing

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