Imaging of inflamed arteries in giant cell arteritis and inflamed joints in rheumatoid arthritis with a PET/CT scan.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

26 Nov 2024 → ongoing

Decision date (initial)

2024-07-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Diagnosis

Primary Objective: to evaluate arterial and synovial 89Zr-Dfcrefmirlimab uptake on PET/CT in patients with newly-diagnosed GCA or active RA.

Conditions and MedDRA coding

giant cell arteritis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Giant cell arteritis: - Age > 50 years - Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L - Clinical symptoms of GCA present at time of inclusion: • Large vessel GCA (at least one of the following): constitutional symptoms (fatigue, fever, weight loss, and/or night sweats), limb claudication, or symptoms of polymyalgia rheumatica (i.e. shoulder and/or hip girdle pain associated with morning stiffness) • Cranial GCA (at least one of the following): new-onset localized headache, scalp tenderness, temporal artery abnormality (thickening, tenderness, and/or decreased pulsation), ischemia-related vision loss, stroke, transient ischemic attack, jaw or tongue claudication (pain upon mastication). - Imaging findings or temporal artery biopsy findings consistent with GCA at the time of inclusion • Large vessel GCA as suggested by ultrasonography or FDG-PET/CT • Cranial GCA as suggested by ultrasonography FDG-PET/CT or temporal artery biopsy and confirmed by temporal artery biopsy - 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. Rheumatoid arthritis - Patients must be at least 30 years of age - Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria. - Patients with clinically active disease as assessed by a physician; with arthritis in at least one wrist, knee or ankle joint and have a clinical indication to initiate or escalate treatment - 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 - Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion - 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. Giant cell arteritis - Age ≤ 50 years - Use of oral, intravenous or intramuscular glucocorticoids within 4 weeks prior to inclusion. - Use of disease-modifying antirheumatic drugs (DMARD) within 3 months prior to inclusion. - Treatment with any investigational drug within 3 months prior to inclusion. - Known pregnancy or breast feeding - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion. - Urinary or faecal incontinence Rheumatoid arthritis A potential subject who meets any of the following criteria will be excluded from participation in this study: - Age < 30 years - Use of intra-articular, intramuscular or intravenous corticosteroids within 4 weeks prior to inclusie - 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 - Urinary or faecal incontinence

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary 89Zr-Df-crefmirlimab PET/CT measurements are the tracer uptake in different arteries or joints whereby the radioactivity concentration in Regions-of-Interest (ROIs) are expressed as SUVs (Standardized Uptake Values).

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

K.S.M. van der Geest

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

K.S.M. van der Geest

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 6 files

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

Application history

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