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

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2018-001114-15-NL
• Date of registration: 28/05/2018
• Prospective Registration: Yes
• Primary sponsor: VU Medical Center, department of Rheumatology
• Public title: Predicting the risk for rheumatoid arthritis with the help of a PET scan.
• Scientific title: Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - Early diagnostics in RA
• Date of first enrolment: 18/09/2018
• Target sample size: 60
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-001114-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands

Contacts

• Name: Principal Investigator
• Affiliation: VU Medical Center, department of Rheumatology

• Name: Principal Investigator
• Affiliation: VU Medical Center, department of Rheumatology

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: [18F]PEG-Folate
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

Secondary Objective: Not applicable.

Main Objective: 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.

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.

Timepoint(s) of evaluation of this end point: Two years.

Secondary Outcome(s)

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).

Timepoint(s) of evaluation of this end point: Two years.

Secondary ID(s)

01-13032018

Source(s) of Monetary Support

VU Medical Center, department of Rheumatologie

ZonMw

Ethics review

Status: Approved
Approval date:
Contact: