Clinical Trials Register

Summary
EudraCT Number:	2017-004850-40
Sponsor's Protocol Code Number:	01-0712-2017
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:	2018-02-28
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

2017-004850-40

A.3

Full title of the trial

[18F]Fluoride PET-CT imaging for detection and monitoring of bone formation in spondyloarthritis

[18F]Fluoride PET-CT beeldvorming voor het aantonen en monitoren van botformatie bij spondylartritis.

A.3.1

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

Detection and monitoring of effects of biological therapy on bone formation in patients with Bechterew's disease or psoriatic arthritis with the use of a Positron Emission Tomography (PET) scan.

Opsporen en vervolgen van effecten van biologicals op botaanmaak bij patiënten met de ziekte van Bechterew of artritis psoriatica met behulp van een Positron Emissie Tomografie (PET) scan.

A.3.2

Name or abbreviated title of the trial where available

[18F]Fluoride PET in SpA

[18F]Fluoride PET bij SpA

A.4.1

Sponsor's protocol code number

01-0712-2017

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 Rheumatology
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	Pfizer
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	Foreum
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	Novartis
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]Fluoride
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

Spondyloarthritis (ankylosing spondylitis and psoriatic arthritis)

Spondylartritis (ziekte van Bechterew en artritis psoriatica)

E.1.1.1

Medical condition in easily understood language

Spondyloarthritis (ankylosing spondylitis and psoriatic arthritis)

Spondylartritis (ziekte van Bechterew en artritis psoriatica)

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

The aim is to investigate the therapeutic effects of Secukinumab on bone formation in SpA patients by using [18F]Fluoride PET-CT imaging.

Het doel is om de therapeutische effecten van Secukinumab op botvorming in SpA patienten door middel van [18F]Fluoride PET-CT beeldvorming te onderzoeken.

E.2.2

Secondary objectives of the trial

To investigate cellular and molecular pathology in bone formation.

De cellulaire en moleculaire pathologie in botvorming te onderzoeken.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Patients will receive a PET-CT scan at baseline (before start of Secukinumab or anti-TNF treatment) and a PET-CT scan after 12 weeks of treatment. Additionally, a group of 8 patients included in the sub-study will receive one PET-CT scan and a bone biopsy.

Patiënten zullen twee PET-CT scans ondergaan; op baseline (voor de start van Secukinumab of anti-TNF therapy) en na 12 weken behandeling. Daarnaast zal een groep van 8 patiënten geincludeerd worden in de sub-studie, waarin zij een PET-CT scan zullen ontvangen en een botbiopsie.

E.3

Principal inclusion criteria

• Diagnosis of psoriatic arthritis according to the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) or ankylosing spondylitis according to the modified New York criteria
• Patients with clinically active disease as assessed by a physician;
o In PsA defined as clinically active disease with at least one clinically active enthesitis site and a clinical indication to start with Secukinumab
o In AS defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 or higher and a clinical indication to start with Secukinumab.
• Treatment with disease modifying anti-rheumatic drugs (DMARDS) and non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion and during the study up to 12 weeks of follow up.
• Treatment with oral corticosteroids up to 10mg daily is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion and during the study up to 12 weeks of follow up.
• Prior treatment with one anti-TNF agent is permitted with the exception of the anti-TNF control PsA group: they will have no prior anti-TNF treatment and have a clinical indication to start anti-TNF treatment.
• Patients must be able to adhere to the study appointments and other protocol requirements.
• Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.

• Diagnose van artritis psoriatica volgens de 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) of de ziekte van Bechterew volgens de modified New York criteria.
• Patienten met klinisch actieve ziekte zoals bepaald door een arts:
o in PsA gedefinieerd als klinisch actieve ziekte met minimaal een klinisch actieve enthesitis laesie en een klinische indicatie om met Secukinumab te starten.
o In AS gedefinieerd als een Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score van 4 of hoger en een klinische indicatie om met Secukinumab te starten.
• Behandeling met disease modifying anti-rheumatic drugs (DMARDS)en non-steroidal anti-infiammatory drugs (NSAID) is toegestaan, mits er in de maand voorafgaand aan inclusie en in de eerst 12 weken van de studie een stabiele dosis gebruikt wordt.
• Behandeling met orale corticosteroiden tot 10mg per dag is toegestaan, mits er in de maand voorafgaand aan inclusie en in de eerst 12 weken van de studie een stabiele dosis gebruikt wordt.
• Eerdere behandeling met één anti-TNF middel is toegestaan, met de uitzondering van de anti-TNF controle groep: zij moeten geen eerdere anti-TNF middelen gebruikt hebben, en een klinisch indicatie om te starten met anti-TNF behandeling.
• Patiënten moeten in staat zijn om zich te houden aan studie afspraken en andere protocol verplichtingen.
• 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

• Treatment with any investigational drug within the previous 3 months.
• Pregnancy or breast-feeding

• Behandeling met onderzoeksmedicatie in de afgelopen 3 maanden.
• Zwangerschap of het geven van borstvoeding.

E.5 End points

E.5.1

Primary end point(s)

Our main endpoint is data collection of the baseline and follow up [18F]Fluoride whole body PET-CT scans from 40 SpA patients. Clinical response to treatment in follow-up assessmenst will be the gold standard.

Onze primaire uitkomstmaat is het verzamelen van baseline en follow up data van [18F]Fluoride whole body PET-CT scans van 40 SpA patienten. Klinische respons op behandeling in follow up beoordeling zal de gouden standaard zijn.

E.5.1.1

Timepoint(s) of evaluation of this end point

One year.

Een jaar.

E.5.2

Secondary end point(s)

Our secondary endpoint is the histological staining of samples taken by PET-guided bone biopsies from 8 clinically active AS patients.

Onze secundaire uitkomstmaat is de histologische kleuring van samples afgenomen via PET-begeleide botbiopten van 8 klinisch actieve AS patienten.

E.5.2.1

Timepoint(s) of evaluation of this end point

One year.

Een 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

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

The last visit of the last subject undergoing the trial.

De laatste visite van de laatste deelnemer van de studie.

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