Clinical Trials Register

Summary
EudraCT Number:	2018-003351-37
Sponsor's Protocol Code Number:	I4V-MC-JAJA
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-09-16
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

Spain - AEMPS

A.2

EudraCT number

2018-003351-37

A.3

Full title of the trial

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis.

Estudio de fase 3b/4, aleatorizado, comparativo con un tratamiento activo, con grupos paralelos, en el que se evalúa baricitinib en pacientes con artritis reumatoide.

A.3.1

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

A Phase 3b/4 Study in Rheumatoid Arthritis

Estudio de fase 3b/4 en artritis reumatoide

A.3.2

Name or abbreviated title of the trial where available

RA-BRIDGE

A.4.1

Sponsor's protocol code number

I4V-MC-JAJA

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03915964

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	Lilly S.A
B.1.3.4	Country	Spain
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	Eli Lilly and Company
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	Eli Lilly Cork Ltd
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Island House, Eastgate Road, Eastgate Business Park
B.5.3.2	Town/ city	Little Island
B.5.3.3	Post code	.
B.5.3.4	Country	Ireland
B.5.6	E-mail	ensayosclinicos@lilly.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	Yes
D.2.1.1.1	Trade name	Olumiant
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, the Netherlands
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.3.1	Product name	Olumiant
D.3.2	Product code	LY3009104
D.3.4	Pharmaceutical form	Film-coated 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	BARICITINIB
D.3.9.1	CAS number	1187594-09-7
D.3.9.4	EV Substance Code	SUB180983
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	4
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	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	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: 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	Olumiant
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, the Netherlands
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.3.1	Product name	Olumiant
D.3.2	Product code	LY3009104
D.3.4	Pharmaceutical form	Film-coated 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	BARICITINIB
D.3.9.1	CAS number	1187594-09-7
D.3.9.4	EV Substance Code	SUB180983
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	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	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	Enbrel
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer 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	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.3.8	INN - Proposed INN	ETANERCEPT
D.3.9.1	CAS number	185243-69-0
D.3.9.4	EV Substance Code	SUB01984MIG
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	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: 4
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	Humira
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Deutchland GmbH & Co. Kg
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	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.3.8	INN - Proposed INN	ADALIMUMAB
D.3.9.1	CAS number	331731-18-1
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	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	Yes
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	21.0
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 compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of VTE.

Comparar baricitinib (considerando todos los grupos de administración) con los inhibidores del TNF, desde el punto de vista de la TEV.

E.2.2

Secondary objectives of the trial

•To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of key safety outcomes.
•To compare each baricitinib dose to TNF inhibitors with respect to the risk of key safety outcomes.

• Comparar baricitinib (considerando todos los grupos de administración) con los inhibidores del TNF, desde el punto de vista del riesgo de los principales criterios de valoración de la seguridad.
• Comparar cada dosis de baricitinib con los inhibidores del TNF con respecto al riesgo de los principios criterios de valoración de la seguridad.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).
Participants must have at least one of the following characteristics:
•Documented evidence of a VTE prior to this study
•At least 60 years of age or older
• A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m2), or
•Age 50 to less than 60 years AND BMI 25 to less than 30 kg/m2.

Los participantes deben presentar una respuesta insuficiente o intolerancia al menos a un fármaco antirreumático modificador de la enfermedad (FARME) (sintético o biológico).
Los pacientes deben presentar al menos una de las características siguientes:
• signos documentados de TEV antes de este estudio;
• edad mínima de 60 años;
• índice de masa corporal (IMC) igual o mayor de 30 kilogramos por metro cuadrado (kg/m2), o
• edad de entre 50 años y menos de 60 años Y un IMC de entre 25 y menos de 30 kg/m2.

E.4

Principal exclusion criteria

•Participants must not have any problems taking a tumor necrosis factor (TNF) inhibitor, baricitinib, the active substance, or any of the excipients listed in the SmPC Section 6.1.
•Participants must not be pregnant or breastfeeding.
•Participants must not have had more than one VTE.
•Participants must not have cancer.
•Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness.This is also applicable to patients with evidence of HIV infection and/or who are positive for anti-HIV antibodies.
•Participants must not have had a live vaccine within four weeks of study start.
•Participants must not have participated in any other clinical trial within four weeks of study randomisation
•Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

• Los participantes no deben tener ningún problema en tomar inhibidores del factor de necrosis tumoral (TNF),baricitinib, la sustancia activa, o cualquier otro excipiente listado en la sección 6.1 del SmPC.
• Las participantes no deben estar embarazadas ni en período de lactancia.
• Los participantes no deben haber sufrido más de un episodio de TEV.
• Los participantes no deben padecer cáncer.
• Los pacientes no deben presentar herpes zóster activo, infecciones graves, tuberculosis activa ni cualquier otra enfermedad grave. Esto también es aplicable a pacientes con evidencia de infección por VIH y/o que sean positivos para anticuerpos anti-VIH.
• Los participantes no deben haber recibido una vacuna elaborada con microbios vivos en el transcurso de las cuatro semanas anteriores al inicio del estudio.
• Los participantes no deben haber participado en otro ensayo clínico en el transcurso de las cuatro semanas anteriores a la aleatorización del estudio.
• Los participantes no deben tener antecedentes de alcoholismo crónico, drogadicción (drogas intravenosas) u otra toxicomanía ilegal en el transcurso del último año.

E.5 End points

E.5.1

Primary end point(s)

Time from first dose of study treatment to first event of Venous thromboembolism (VTE).

Tiempo transcurrido desde la primera dosis del tratamiento del estudio hasta el primer acontecimiento de tromboembolia venosa (TVE).

E.5.1.1

Timepoint(s) of evaluation of this end point

This endpoint will be evaluated at week 12, week 28, week 52 and every 24 weeks thereafter.

Este criterio de valoración se evaluará en las semanas 12, 28 y 52, y a partir de entonces cada 24 semanas.

E.5.2

Secondary end point(s)

Time from first dose of study treatment (combined baricitinib doses compared to TNF inhibitors) to first event of:
Arterial thromboembolic event (ATE)
Major adverse cardiovascular events (MACE)
Malignancy (excluding Nonmelanoma skin cancer(NMSC))
Opportunistic infection
Serious infection

Time from first dose of study treatment (each individual baricitinib dose compared to TNF inhibitor) to first event
of:
VTE
ATE
MACE
Malignancy (excluding NMSC)
Opportunistic infection
Serious infection

Tiempo transcurrido desde la primera dosis del tratamiento del estudio (comparando todas las dosis de baricitinib con los inhibidores del TNF) hasta el primer caso de:
Episodio tromboembólico arterial (ETA):
 Acontecimiento cardiovascular adverso importante (ACAI)
 Neoplasia maligna (salvo los casos de cáncer de piel no melanomatoso [CPNM])
 Infección oportunista
 Infección grave
Tiempo transcurrido desde la primera dosis del tratamiento del estudio (comparando cada dosis de baricitinib con los inhibidores del TNF) hasta el primer acontecimiento de:
 TVE
 ETA
 ACAI
 Neoplasia maligna (excepto los casos de cáncer de piel no melanomatoso)
 Infección oportunista
 Infección grave

E.5.2.1

Timepoint(s) of evaluation of this end point

Endpoints will be evaluated at week 12, week 28, week 52 and every 24 weeks thereafter (all visits after randomisation).

Los criterios de valoración se evaluarán en las semanas 12, 28 y 52, y a partir de entonces cada 24 semanas (en todas las visitas posteriores a la aleatorización).

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)

Yes

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

Yes

E.8.1.7.1

Other trial design description

Miembros del equipo central de estudio ciegos

Blinded core study team members

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

161

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

Australia

Austria

Belgium

Czech Republic

Denmark

France

Germany

Greece

Hungary

Israel

Italy

Lithuania

Netherlands

Poland

Romania

Russian Federation

Slovakia

South Africa

Spain

Switzerland

Turkey

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

End of trial is the date of the last visit or last scheduled procedure as per the protocol schedule of activities, for the last patient.

El final del ensayo es la fecha de la última visita o del último procedimiento programado para el último paciente del estudio, según se detalla en el calendario de actividades.

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

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:

2080

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

520

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

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1100

F.4.2.2

In the whole clinical trial

2600

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)

Neither baricitinib nor TNF inhibitor will be made available by the sponsor after conclusion of the study.

Tras la conclusión del estudio, el promotor no le proporcionará ni baricitinib ni inhibidores del TNF.

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

2019-09-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-24

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

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