Clinical Trials Register

Summary
EudraCT Number:	2011-002144-27
Sponsor's Protocol Code Number:	M12-146
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-03-13
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

2011-002144-27

A.3

Full title of the trial

A Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Pain from Osteoarthritis of the Knee

Sperimentazione multicentrica randomizzata, in doppio cieco, con controllo attivo e placebo, per confrontare la sicurezza e l'efficacia analgesica di ABT-110 verso placebo in soggetti con dolore da osteoatrosi del ginocchio.

A.3.1

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

A Study Comparing the Safety and Analgesic Efficacy of ABT-110 in Subjects with Pain from Osteoarthritis of the Knee

Sperimentazione per confrontare la sicurezza e l'efficacia analgesica di ABT-110 in soggetti con dolore da osteoatrosi del ginocchio.

A.4.1

Sponsor's protocol code number

M12-146

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	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	Abbott Laboratories
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	Abbott Laboratories
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	Abbott House, Vanwall Business Park
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4XE
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 1628 644475
B.5.5	Fax number	+44 1628 644330
B.5.6	E-mail	euclinicaltrials@abbott.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	NA
D.3.2	Product code	ABT-110
D.3.4	Pharmaceutical form	Powder for 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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	ABT-110
D.3.9.3	Other descriptive name	Humanized anti-Nerve Growth Factor IgG4 kappa monoclonal antibody
D.3.9.4	EV Substance Code	NA
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	20
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: 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	Naprosyn (naproxen) tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Products Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	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	NAPROXEN
D.3.9.1	CAS number	22204-53-1
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB09159MIG
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	500
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.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	Powder for 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

Pain from Osteoarthritis of the Knee

Dolore da osteoartrosi del ginocchio

E.1.1.1

Medical condition in easily understood language

Pain from Osteoarthritis of the Knee

Dolore da osteoatrosi del ginocchio

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10031165
E.1.2	Term	Osteoarthritis knee
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 of this study is to compare the safety, tolerability and analgesic efficacy of ABT-110 administered SC once every 8 weeks (q8w) for a total of 3 doses to placebo in subjects with pain due to OA of the knee.

L’obiettivo primario di questa sperimentazione è di confrontare la sicurezza, la tollerabilità e l’efficacia analgesica di ABT-110, somministrato per via sottocutanea (SC) una volta ogni 8 settimane per un totale di 3 somministrazioni, verso placebo, in soggetti con dolore da osteoatrosi del ginocchio.

E.2.2

Secondary objectives of the trial

A secondary objective of this study is to explore the population pharmacokinetics of ABT-110.

L’obiettivo secondario di questa sperimentazione è di esplorare la farmacocinetica di popolazione di ABT-110.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject is between 18 and 70 years of age, inclusive. 2. Osteoarthritis pain in the index knee which meets the following: ● History of pain in the index knee ≥ 6 months; AND ● K-L Grade 2 or 3 only on plain radiographs of the index knee; AND ● At least 1 of the following 3 criteria: ○ Age > 50 years; OR ○ Stiffness < 30 minutes upon awakening; OR ○ Crepitus in the index knee. 3. Subject must meet the following pain criteria at the time of the Baseline Visit: ● Subject's Assessment of Arthritis Pain Intensity (VAS) of the index knee is ≥ 40 mm with an increase of ≥ 10 mm from the Screening Visit, o For subjects whose Screening VAS is ≥ 85 mm, a VAS of ≥ 85 mm must be maintained at the Baseline Visit; AND ● Subject's Global Assessment of Arthritis Status must be Fair, Poor or Very Poor. 4. Subject requires therapeutic doses of at least 1 non-opioid analgesic for OA pain for at least 4 days per week during the 4 weeks prior to the Screening Visit.

1. Soggetti di età compresa tra 18 e 70 anni. 2. Dolore da osteoatrosi del ginocchio affetto con le seguenti caratteristiche:  Storia di dolore al ginocchio affetto ≥ 6 mesi, E  Kellgren-Lawrence (K-L) di grado 2 o 3, alle radiografie del ginocchio affetto, E  Almeno uno dei seguenti requisiti: o Età > 50 anni, OPPURE o Rigidità < 30 minuti al risveglio, OPPURE o Crepitii al ginocchio affetto 3. I soggetti devono rispettare i seguenti criteri del dolore al momento della visita basale: - la valutazione del soggetto dell’intensità del dolore da osteoartrosi secondo la scala analogico-visiva (VAS) ≥ 40 mm con un aumento di ≥ 10 mm rispetto al punteggio ottenuto alla visita di screening, - Per i soggetti la cui VAS allo screening è ≥ 85 mm, deve essere mantenuto un punteggio VAS di ≥ 85 mm al basale; E - la valutazione globale del soggetto dello “status “ di osteoartrosi deve essere moderata, scarsa o molto scarsa. 4. I soggetti necessitano di dosi terapeutiche di almeno 1 analgesico non oppiaceo per il trattamento del dolore da OA per almeno 4 giorni la settimana durante le 4 settimane precedenti la visita di screening.

E.4

Principal exclusion criteria

1. Subject is scheduled for or is considering joint replacement surgery within 6 months following the Screening Visit. 2. Subject has had any of the following: ● Joint replacement/reconstruction to the index joint at any time; ● Any major surgery, e.g., open surgery, to the index joint within 12 months prior to the Screening Visit; OR ● Arthroscopic surgery to the index joint within 3 months prior to the Screening Visit. 3. Subject has a history of osteonecrosis in any joint. 4. Subject has OA of the knee that meets the K-L classification criteria of grade 0, 1 or 4.

1. Soggetti che hanno programmato o considerano di sottoporsi ad un intervento chirurgico di artroprotesi entro 6 mesi dopo la visita di screening. 2. Soggetti che hanno avuto uno dei seguenti interventi: • artroprotesi del ginocchio affetto in qualsiasi momento • Un qualsiasi intervento di chirurgia maggiore, per esempio un intervento a cielo aperto, al ginocchio affetto nei 12 mesi precedenti la Visita di Screening, OPPURE • Intervento di artroscopia al ginocchio affetto nei 3 mesi precedenti la Visita di Screening. 3. Soggetti con storia di osteonecrosi a qualsiasi articolazione. 4. Soggetti che hanno OA del ginocchio con classificazione K-L di grado 0, 1 o 4.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline to subject's final evaluation on pain intensity as measured by a 100 mm Visual Analog Scale (VAS)

Variazione, dal basale fino alla valutazione finale del soggetto, dell’intensità del dolore valutata mediante Scala Analogico Visiva (VAS) di 100 mm.

E.5.1.1

Timepoint(s) of evaluation of this end point

0, 8, 16 and 24 weeks

A zero, 8, 16 e 24 settimane

E.5.2

Secondary end point(s)

Western Ontario and McMasters Osteoarthritis Index (WOMAC™), EuroQol-5D™ (EQ-5D-5L), Work Productivity and Activity Impairment (WPAI) Questionnaire

Western Ontario and McMaster Osteoarthritis Index (WOMAC), Euro QoL-5D (EQ-5D-5L), Work Productivity and activity Impairment (WPAI) Questionnaire.

E.5.2.1

Timepoint(s) of evaluation of this end point

0, 8, 16 and 24 weeks

A zero, 8, 16 e 24 settimane

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

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

Singapore

South Africa

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 visit.

La conclusione della sperimentazione è definita come l'ultima visita dell'ultimo soggetto.

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

Number of subjects for this age range:

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:

310

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

200

F.4.2.2

In the whole clinical trial

390

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)

The investigator will discuss the appropriate subsequent treatment with the subject, Naproxen is commercially available; Abbott will not provide Naproxen or any other therapy once the subject's participation is concluded.

Il Medico Sperimentatore discuterà col soggetto il trattamento successivo più appropriato, il Naprossene è disponibile in commercio; Abbott non fornirà né il Naprossene né altre terapie una volta che la partecipazione del soggetto alla sperimentazione sarà conclusa.

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

2012-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-07

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2013-01-31

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