Clinical Trials Register

Summary
EudraCT Number:	2014-003224-40
Sponsor's Protocol Code Number:	42160443PAI3007
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-03-11
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

2014-003224-40

A.3

Full title of the trial

Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Fulranumab as Adjunctive Therapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee

Estudio aleatorizado de 16 semanas, multifase, doble ciego y controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de fulranumab como tratamiento complementario en sujetos con signos y síntomas de artrosis de cadera o rodilla

A.3.1

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

Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007

Estudio de la seguridad, eficacia de Fulranumab Uso complementario en la artrosis de cadera o rodilla, PAI3007

A.4.1

Sponsor's protocol code number

42160443PAI3007

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	Janssen-Cilag International N.V.
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	Janssen Research & Development, LLC
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	Janssen Research and Development
B.5.2	Functional name of contact point	Clinical Registry Group-JB BVent
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	LeidenW
B.5.3.3	Post code	2333CMW
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+34914322630
B.5.5	Fax number	+3107152421 10
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	Fulranumab
D.3.2	Product code	JNJ-42160443
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	Fulranumab
D.3.9.1	CAS number	902141-80-4
D.3.9.2	Current sponsor code	JNJ-42160443
D.3.9.3	Other descriptive name	FULRANUMAB
D.3.9.4	EV Substance Code	SUB31033
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	4
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	Yes
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	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	Fulranumab
D.3.2	Product code	JNJ-42160443
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	Fulranumab
D.3.9.1	CAS number	902141-80-4
D.3.9.2	Current sponsor code	JNJ-42160443
D.3.9.3	Other descriptive name	FULRANUMAB
D.3.9.4	EV Substance Code	SUB31033
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	12
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	Yes
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 in pre-filled syringe
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

Osteoarthritis of the Hip or Knee

Artrosis de cadera o rodilla

E.1.1.1

Medical condition in easily understood language

Osteoarthritis of the Hip or Knee

Artrosis de cadera o rodilla

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	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10023476
E.1.2	Term	Knee osteoarthritis
E.1.2	System Organ Class	100000004859

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10020108
E.1.2	Term	Hips osteoarthritis
E.1.2	System Organ Class	100000004859

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 is to demonstrate the safety and tolerability of fulranumab subcutaneous (SC) injections compared with SC placebo, in subjects with standard of care and who have signs and symptoms of osteoarthritis of the hip or knee.

El objetivo principal es demostrar la seguridad y la tolerabilidad de inyecciones s.c. de fulranumab en comparación con placebo s.c. en sujetos con tratamiento de referencia que presenten signos y síntomas de artrosis de cadera o rodilla.

E.2.2

Secondary objectives of the trial

Secondary Objectives
To evaluate the effect of fulranumab on:
- Efficacy as measured by the subject for pain, function, stiffness, health status and well-being
- Additional analgesic medication use
- Pharmacokinetics and immunogenicity of fulranumab

Objetivos secundarios
Evaluar el efecto de fulranumab sobre:
- La eficacia, medida por el sujeto, en cuanto a dolor, funcionamiento, rigidez, estado de salud y bienestar
- El uso de medicación analgésica adicional
- La farmacocinética e inmunogenicidad de fulranumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class ?2) of the study joint
- Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint
- Unsatisfactory response (inadequate efficacy or poor tolerability) on standard of care that includes 3 of any of the following classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, or opioid)
- Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA
-During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child

- Diagnóstico clínico de artrosis de cadera o rodilla de acuerdo con los criterios establecidos por el American College of Rheumatology e indicios radiográficos de artrosis (clase ?2 en la escala de Kellgren-Lawrence) de la articulación estudiada.
- Tener prevista o programada una artroplastia para la articulación estudiada
-Respuesta insatisfactoria (eficacia inadecuada o mala tolerabilidad) con un tratamiento de referencia que incluya 3 de cualquiera de las siguientes clases de medicamentos analgésicos orales (paracetamol, AINE u opioides).
- Dolor e insuficiencia funcional de moderados a intensos según la NRS, las subescalas de dolor y función física WOMAC y la PGA.
-Durante 24 semanas tras la última inyección del fármaco del estudio: si es mujer en edad fértil, no está embarazada, ni está en periodo de lactancia o tiene intención de quedarse embaraza, o si es hombre, no debe tener intención de ser padre.

E.4

Principal exclusion criteria

-Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
-Unstable or progressive neurologic disorders

- Un aumento del riesgo de padecer osteonecrosis (ON) o artrosis de progresión rápida (rapidly progressive osteoarthritis, RPOA);
- La existencia de trastornos neurológicos inestables o progresivos

E.5 End points

E.5.1

Primary end point(s)

The number of participants with Adverse Events as a measure of safety and tolerability

- El número de participantes con eventos adversos como medida de seguridad y tolerabilidad

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to Week 52

Hasta la semana 52

E.5.2

Secondary end point(s)

- Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score
- Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score

- Cambio desde la visita basal hasta el final de la semana 16 en la sub-escala del dolor Western Ontario y McMaster Índice Artritis Universidad (WOMAC).
- Cambio desde la visita basal hasta el final de la semana 16 en la subescalas de función física Western Ontario y McMaster Universidad Artritis Index (WOMAC).

E.5.2.1

Timepoint(s) of evaluation of this end point

End of week 16

final de la semana 16

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

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

Yes

E.8.1.7.1

Other trial design description

Terapia complementaria

Adjunctive Therapy

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.8.2.4

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

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

Canada

Czech Republic

France

Germany

Hungary

Italy

Korea, Republic of

Mexico

Poland

Romania

Russian Federation

Spain

Sweden

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

LPLV

Último paciente Última visita

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:

600

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

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

257

F.4.2.2

In the whole clinical trial

643

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)

After end of Double blind treatment period patients can continue with their standard of care.

Tras terminar el periodo de tratamiento "doble ciego" los pacientes podrán continuar con el tratamiento de práctica clínica habiutal.

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

2015-07-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2016-09-19

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