[18F]PEG-folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

27 Nov 2024 → ongoing

Decision date (initial)

2024-11-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513537-21-02

EudraCT number

2018-004429-94

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Therapy

The primary objective is to investigate the association between quantitative changes in whole body [18F]PEG Folate PET/CT (Folate PET) after 4 weeks and clinical response to anti-TNF therapy at 26 weeks of treatment in patients with clinically active established RA. The secondary objective is to relate quantitative Folate PET outcome after 4 weeks to histological changes in synovial tissue after 4 weeks of anti-TNF treatment (with a particular focus on macrophage infiltration and FRβ expression).

Conditions and MedDRA coding

Rheumatoid Arthritis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients must be at least 30 years of age - Diagnosis of rheumatoid arthritis according to the 1987 revised criteria of the American Rheumatism Association (ARA)13 and/or the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria. - Patients with clinically active disease as assessed by a physician; with arthritis in at least one joint accessible to synovial biopsy and have a clinical indication to (re)start with anti-TNF (either Infliximab, Etanercept, Adalimumab or Certolizumab). - Prior treatment with one anti-TNF agent (Adalimumab, Certolizumab, Etanercept, Golimumab or Infliximab) is permitted, but may not be a primary failure to any anti-TNF agent (defined as no response within the first 12 weeks of treatment). Patients restarting previously successful aTNF treatment after a >3 month period are also allowed, provided the initial reason for stopping treatment was not ineffectiveness (such as surgery or an infection). - Treatment with disease modifying anti-rheumatic drugs (DMARDS) and oral corticosteroid up to 10 mg daily is allowed, 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. - 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. - 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.

Exclusion criteria 1

1. A potential subject who meets any of the following criteria will be excluded from participation in this study: - Use of intramuscular or intravenous corticosteroids within 4 weeks prior to screening. - Patients who received methotrexate and folic acid less than 7 days before tracer injection - Treatment with any investigational drug within the previous 3 months - Known pregnancy or breast feeding - Research related radiation exposure (cumulative ≥5 mSv) in the year before inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Our main endpoint is the association between quantitative changes in Folate PET after 4 weeks of anti-TNF treatment and clinical response to therapy up to 26 weeks of treatment in patients with established RA. Clinical follow-up up to 26 weeks will be regarded as golden standard.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Amsterdam UMC

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Amsterdam UMC

Sponsor responsibilities

Article 77 compliance

Amsterdam UMC Stichting

Contact point sponsor

Amsterdam UMC Stichting

Article 77 implementation

Amsterdam UMC Stichting

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications