CD8 T cell imaging by positron emission tomography with 89Zr-Df-IAB22M2C in giant cell arteritis and rheumatoid arthritis: a pilot study
- Conditions
- 100038161001336110047066giant cell arteritis (vasculitis)rheumatoid arthritis
- Registration Number
- NL-OMON53860
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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.
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study endpoints: The main endpoints are arterial 89Zr-Df-crefmirlimab<br /><br>uptake in patients with newly-diagnosed GCA, and synovial 89Zr-Df-crefmirlimab<br /><br>uptake in patients with active RA. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include:<br /><br>1) the relationship between 89Zr-Df-crefmirlimab uptake in temporal arteries<br /><br>and the presence of CD8 T cells in histological analysis of temporal artery<br /><br>biopsy in patients with newly-diagnosed, cranial GCA<br /><br>2) the relationship between 89Zr-Df-crefmirlimab uptake and clinical joint<br /><br>assessment and histological analysis of synovial tissue in patients with RA.</p><br>