Clinical Trials Register

Summary
EudraCT Number:	2018-001114-15
Sponsor's Protocol Code Number:	01-13032018
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-05-28
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

Netherlands - Competent Authority

A.2

EudraCT number

2018-001114-15

A.3

Full title of the trial

Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis.

Positron emissie tomografie met een macrofagen tracer voor het selecteren van individuen met een verhoogd risico op reumatoïde artritis.

A.3.1

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

Predicting the risk for rheumatoid arthritis with the help of a PET scan.

Voorspellen van risico op Reumatoïde Artritis met behulp van een PET scan.

A.3.2

Name or abbreviated title of the trial where available

Early diagnostics in RA

Vroegdiagnostiek in RA

A.4.1

Sponsor's protocol code number

01-13032018

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	VU Medical Center, department of Rheumatology
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	VU Medical Center, department of Rheumatologie
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	ZonMw
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	VU Medical Center, department of Rheumatology
B.5.2	Functional name of contact point	Principal Investigator
B.5.3	Address:
B.5.3.1	Street Address	PO Box 7057
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1007 MB
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031204443432
B.5.5	Fax number	0031204442138
B.5.6	E-mail	secr.reumatologie@vumc.nl

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	[18F]PEG-Folate
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	Intravenous bolus use (Noncurrent)
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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Rheumatoid arthritis

Reumatoïde artritis

E.1.1.1

Medical condition in easily understood language

Rheumatoid arthritis

Reumatoïde artritis

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

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 determine the value of quantitative whole body macrophage PET to predict development of clinical arthritis within one year follow-up in ACPA positive arthralgia patients.

Het bepalen van de waarde van kwantitatieve whole body macrofagen PET om de ontwikkeling van klinische artritis binnen een jaar follow-up te voorspellen bij ACPA positieve artralgie patienten.

E.2.2

Secondary objectives of the trial

Not applicable.

Niet van toepassing.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients must be 18 years of age or older
2. Patients must be diagnosed with arthralgia (not secondary to trauma) by a physician
3. Patients must have a positive ACPA blood test
4. Patients must be able to adhere to the study appointments and other protocol requirements.
5. Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.

1. Patiënten moeten 18 jaar of ouder zijn.
2. Patiënten moeten gediagnosticeerd zijn met artralgie (niet secundair aan trauma) door een arts.
3. Patiënten moeten een positieve ACPA bloed test hebben.
4. Patiënten moeten in staat zijn om zich te houden aan studie afspraken en andere protocol verplichtingen.
5. Patiënten moeten in staat zijn om een geïnformeerde keuze te maken over deelname aan het onderzoek, en moeten toestemming geven voor start van het onderzoek.

E.4

Principal exclusion criteria

1. Arthritis and/or tenosynovitis as revealed by physical examination of 44 joints through the Disease Activity Score (DAS) (34) by 2 independent physicians
2. Previous corticosteroid injection in joints
3. Trauma involving joints in the 6 months prior to inclusion
4. Pregnancy or breast-feeding.

1. Artritis en/of tenosynovitis zoals aangetoond door een onderzoek van 44 gewrichten door middel van de Disease Activity Score (DAS) door 2 onafhankelijke artsen.
2. Eerdere corticosteroide injecties in gewrichten
3. Trauma met gewrichtsbetrokkenheid in 6 maanden voorafgaand aan inclusie
4. Zwangerschap of borstvoeding

E.5 End points

E.5.1

Primary end point(s)

The diagnostic performance (PPV, NPV, sensitivity and specificity) of quantitative whole body PET and macrophage targeting for development of clinical arthritis in ACPA positive arthralgia individuals during one year follow-up.

De diagnostische prestatie (PPV, NPV, sensitiviteit en specificiteit) van kwantitatieve whole body PET en macrofaag targeting voor ontwikkeling van klinische artritis in ACPA positieve artralgie individuen gedurende een jaar follow-up.

E.5.1.1

Timepoint(s) of evaluation of this end point

Two years.

Twee jaar.

E.5.2

Secondary end point(s)

1. The relationship between quantitative PET outcome and time to progression to clinical arthritis .
2. The diagnostic performance of quantitative whole body macrophage PET in ACPA positive arthralgia patients for development of RA (diagnosed according to 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria).

1. De relatie tussen kwantitatieve PET uitkomst en tijd tot progressie van klinische artritis.
2. De diagnostische prestatie van kwantitatieve whole body macrofaag PET in ACPA positieve artralgie patienten voor de ontwikkeling van RA (gediagnosticeerd volgens de 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria).

E.5.2.1

Timepoint(s) of evaluation of this end point

Two years.

Twee jaar.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

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:

F.1.3

Elderly (>=65 years)

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