E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
giant cell arteritis and rheumatoid arthritis |
reuscelarteriitis en reumatoïde artritis |
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E.1.1.1 | Medical condition in easily understood language |
giant cell arteritis and rheumatoid arthritis |
reuscelarteriitis en reumatoïde artritis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary Objective: to evaluate arterial and synovial 89Zr-Df-crefmirlimab uptake on PET/CT in patients with newly-diagnosed GCA or active RA. |
Primaire doel: evalueren van arteriële en synoviale 89Zr-Df-crefmirlimab opname op PET/CT in patiënten met nieuwe RCA of actieve RA. |
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E.2.2 | Secondary objectives of the trial |
1. Assessment of the relationship between 89Zr-Df-crefmirlimab uptake and the presence of CD8 T cells in histological analysis of the temporal artery biopsy in patients with newly-diagnosed, cranial GCA 2. Assessment of the relationship between 89Zr-Df-crefmirlimab uptake and clinical joint assessment and histological analysis of synovial tissue in patients with RA.
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1. Bepalen van relatie tussen 89Zr-Df-crefmirlimab opname en aanwezigheid van CD8 T cellen in histologische analyse van arteria temporalis biopten van patiënten met nieuwe, craniële RCA 2. Bepalen van relatie tussen 89Zr-Df-crefmirlimab opname en bevindingen bij klinische gewrichtsonderzoek en histologische analyse van synoviale weefsels van patiënten met RA.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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Reuscelarteriitis: - Leeftijd > 50 jaar - BSE 50 mm/uur of meer; of CRP 10 mg/L of meer - Aanwezigheid van klinische symptomen van RCA - Beeldvorming of arteria temporalis biopt positief voor RCA - In staat tot nakomen van studieafspraken en andere protocolverplichtingen - In staat tot geven informed consent; consent moet verkregen worden vóór start studiegerelateerde procedures
Reumatoïde artritis - Leeftijd >30jaar - Voldoen aan 2010 ACR/EULAR classificatiecriteria voor RA - Actieve ziekte volgens arts; met artritis minimaal in 1 pols, knie of enkel; met klinische noodzaak tot starten dan wel ophogen van behandeling - Behandeling met DMARDs of orale corticosteroiïden (max 10 mg prednisolon equivalent dag) - NSAID gebruik is toegestaan mits stabiele dosering gedurende 4 weken voor inclusie - In staat tot nakomen van studieafspraken en andere protocolverplichtingen - In staat tot geven informed consent; consent moet verkregen worden vóór start studiegerelateerde procedures
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E.4 | Principal exclusion criteria |
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
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Reuscelarteriitis: - Leeftijd 50 jaar of minder - Gebruik van orale, intraveneuze of intramusculaire glucocorticoiden in periode 4 weken voor inclusie - Gebruiken DMARD in 3 maanden voor inclusie - Behandeling met investigational drug in 3 maanden voor inclusie - Actuele zwangerschap of geven van borstvoeding - Onderzoeksgerelateerde blootstelling aan straling (cumulatief 5 mSv of meer) in jaar voor inclusie - Incontintentie voor urine of feces
Reumatoide artritis - Leeftijd < 30 jaar - Gebruik intra-articulaire, intramusculaire of intraveneuze corticosteroiden in 4 weken voor inclusie - Behandeling met investigational drug in 3 maanden voor inclusie - Actuele zwangerschap of geven van borstvoeding - Onderzoeksgerelateerde blootstelling aan straling (cumulatief 5 mSv of meer) in jaar voor inclusie - Incontinentie voor urine of feces |
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E.5 End points |
E.5.1 | Primary end point(s) |
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). |
Primaire 89Zr-Df-crefmirlimab PET/CT metingen zijn tracer opname in verschillende arteriën of gewrichten waarbij radioactiviteit concentratie in 'regions of interest' (ROIs) worden uitgedrukt als SUVs (standardized uptake values). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. The relationship between 89Zr-Df-crefmirlimab uptake and the presence of CD8 T cells in histological analysis of the temporal artery biopsy in patients with newly-diagnosed, cranial GCA 2. Assessment of the relationship between 89Zr-Df-crefmirlimab uptake and clinical joint assessment and histological analysis of synovial tissue in patients with RA.
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1. Relatie tussen 89Zr-Df-crefmirlimab opname en aanwezigheid van CD8 T cellen in histologische analyse van arteria temporalis biopten van patiënten met nieuwe, craniële RCA 2. Relatie tussen 89Zr-Df-crefmirlimab opname en bevindingen van klinische gewrichtsbeoordeling en histologische analyse van synoviaal weefsel in patiënten met RA |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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LVLS |
laatste visite van laatste proefpersoon |
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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 | |