An interventional study of MRI and Blood sample collection in Antiphospholipid Syndrome, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic
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Among 31 studies in Antiphospholipid Syndrome with a site in France — 11 open to participants now, 11 under way, 1 of them phase 3. Antiphospholipid Syndrome · France.
Among the 31 studies in Antiphospholipid Syndrome with a site in France, this one is the 9th largest by enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2018, is one of 7 with no phase, and was the 9th registered.
121 studies on the registry are indexed under Antiphospholipid Syndrome; 52 are open to participants now.
Browse Antiphospholipid Syndrome studies →11 of the 31 studies in Antiphospholipid Syndrome with a site in France are open now. Recruiting first, the newest first:
University Hospital, Strasbourg, France · Sites in France
Ages 18–70
CHU de Reims · Sites in France
Ages 65+
Centre Hospitalier Universitaire, Amiens · Sites in France
Ages 18+ · Healthy volunteers
Chugai Pharmaceutical · Sites in France, United States, Australia and 17 more countries
Ages 18–85
Central Hospital, Nancy, France · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 38 Antiphospholipid Syndrome studies recruiting now, 14 (37%) set no upper age limit and 19 (50%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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31 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 50 is above the median of 41 across 65 interventional studies indexed under Antiphospholipid Syndrome.
Median enrollment 102 across the 14 interventional studies, 310 across the 17 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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2 of 31 have an industry lead sponsor. The 10 most frequent:
Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Central Hospital, Nancy, France has 7 studies filed under Antiphospholipid Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Antiphospholipid Syndrome with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06371417Chugai PharmaceuticalPhase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) | 2027-03-31 |
| NCT07178925University Hospital, RouenFollow-up Cohort of Patients With Antiphospholipid Syndrome | 2027-10-16 |
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Among the 31 studies in Antiphospholipid Syndrome with a site in France, from their registry updates:
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Introduction
AntiPhospholipid antibody Syndrome (APS) is an acquired autoimmune disorder defined by the presence of persistent thrombosis or obstetric manifestations together with the presence of persistent antiphospholipid antibodies (aPL). Patients are young and at high risk of recurrence. The current challenge is the identification of patients at high risk of organ damage that directly impact morbidity and mortality.
Small vessels thrombosis can be asymptomatic but detectable by MRI. Apart from APS, it was shown that the detection of asymptomatic ischemic events identify patients at risk for symptomatic ischemic events. Demonstrating this in patients with APS would prevent thrombotic complications.
The investigators' hypothesis is that a significant proportion of patients with APS would have asymptomatic organ involvement.
Objectives
The primary objective is to determine the frequency of asymptomatic target organ (s) (heart, brain, kidney) in APS patients.
Secondary objectives are (i) to determine the frequency of each type of MRI abnormality, (ii) to identify the factors associated with asymptomatic target organ lesion, (iii) to describe the parameters of echocardiography associated with cerebral and cardiac MRI, and (iv) to assess the feasibility of a one-time cardiovascular and brain MRI.
Methods and analysis
This is a prospective interventional, cross-sectional, non-randomized, monocentric clinical study. The investigators expect to include 50 consecutive patients with APS followed in the department of Vascular Medicine at Nancy University Hospital.
Within 15 days post-inclusion, a one-time cardiac and cerebral MRI will be performed. For each patient, the number of target organs involvements will be calculated and the frequencies will be compared by Fisher or chi-2 tests.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Persons referred to in Articles L. 1121-5 to L. 1121-8, L1122-2 and L. 1122-1-2 of the French Public Health Code :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: MRI · Biological: Blood sample collection
Brain and cardiac MRI in one time with gadolinium injection.
A blood sampling is also collected for hematocrit measure.
A brain or cardiac involvement will be defined by the identification of specific criteria visible by MRI.
Time frame: Through study completion, in average of 24 months
Renal damage will be defined by the identification of a microalbuminuria> 30mg / L.
Time frame: Through study completion, in average of 24 months
Ran from Jul 2018 to primary completion in Jan 2022, 41 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →