Clinical trials: Thrombotic Antiphospholipid Syndrome
Antiphospholipid Syndrome (APS), Cohort Study
DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study
Antiphospholipid syndrome (APS) is a thrombotic disease requiring prolonged anticoagulation. Direct oral anticoagulants (DOACs) are indicated as 1st-line therapy in venous thrombosis, compared with VKAs, due to their easier…
- Conditions
- Antiphospholipid Syndrome (APS), Cohort Study, Thrombotic and Bleeding Events
- Trial name
- DOWAPS (NCT06884384)
- Testing
- Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml), Completion of a questionnaire on compliance with anticoagulant treatment, Completion of a questionnaire on satisfaction with treatment anticoagulant
- Where
- 13 sites in France
- Volunteers
- 310 people
- Sponsor
- Central Hospital, Nancy, France
Systemic Lupus Erythematosus, Inflammatory Myopathy
BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases
The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Inflammatory Myopathy, Systemic Sclerosis (SSc), ANCA-associated Vasculitis
- Trial name
- NCT06794008
- Testing
- BCMA-CD19 CAR-T therapy
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking University People's Hospital
Antiphospholipid Syndrome, Thrombotic Antiphospholipid Syndrome
Anticoagulant Cessation After Antiphospholipid Autoantibodies Loss in Thrombotic Antiphospholipid Syndrome
This is an open-label, non-inferiority, randomized controlled trial with two parallel arms (experimental and control), following a PROBE (Prospective Randomized Open, Blinded Endpoint) design.
- Conditions
- Antiphospholipid Syndrome, Thrombotic Antiphospholipid Syndrome, Thrombosis
- Trial name
- ADORA (NCT07875153)
- Testing
- Vitamin K Antagonist - Drug, Anticoagulant Therapy Discontinuation
- Where
- France
- Volunteers
- 234 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Antiphospholipid Syndrome (APS), Venous Thrombosis (Disorder)
Observational Study to Evaluate the Effectiveness of DOACS for Secondary Thrombosis Prevention in Low-risk Thrombotic APS Patients
This is an observational study designed to evaluate the effectiveness and safety of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) for the secondary prevention of thrombosis in patients with…
- Conditions
- Antiphospholipid Syndrome (APS), Venous Thrombosis (Disorder), Thrombophilia
- Trial name
- DOACS-APS (NCT07372170)
- Where
- 2 sites in Spain
- Volunteers
- 600 people
- Sponsor
- Infanta Leonor University Hospital
Antiphospholipid Syndrome (APS), Direct Oral Anticoagulants (DOACs)
OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
This registry will make it possible to collect large-scale data on SAPL patients, particularly those treated with DOACs, in order to better assess the frequency of thrombotic and hemorrhagic events in this population of…
- Conditions
- Antiphospholipid Syndrome (APS), Direct Oral Anticoagulants (DOACs), Thrombotic and Bleeding Events, Safety
- Trial name
- OBSTINATE 2 (NCT06929182)
- Testing
- "non-high risk" thrombotic APS patients treated with DOAC
- Where
- Spain
- Volunteers
- 500 people
- Sponsor
- Central Hospital, Nancy, France
Antiphospholipid Syndrome, Arterial Thrombosis
Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
The goal of this registry is to gather more information on the efficacy and safety of various antithrombotic regimens. The registry collects data on patients with antiphospholipid syndrome and an arterial event within the past 12…
- Trial name
- NCT05646394
- Testing
- Dual antiplatelet therapy, Combined antithrombotic therapy, Vitamin K antagonist standard intensity
- Where
- 3 sites in Argentina, Canada
- Volunteers
- 150 people
- Sponsor
- McMaster University
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose…
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM)
- Trial name
- NCT06371417
- Testing
- RAY121
- Where
- 77 sites in United States, Australia and 18 more
- Volunteers
- 144 people
- Sponsor
- Chugai Pharmaceutical
Antiphospholipid Syndrome
Clinical Outcomes of Primary Versus Secondary Antiphospholipid Syndrome
Observational retrospective cohort study to assess clinical outcomes in patients with primary versus secondary antiphospholipid syndrome
- Trial name
- NCT06808607
- Where
- Egypt
- Volunteers
- 52 people
- Sponsor
- Assiut University
Antiphospholipid Syndrome, Thrombosis
International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
- Conditions
- Antiphospholipid Syndrome, Thrombosis, Anticoagulants Causing Adverse Effects in Therapeutic Use
- Trial name
- OBSTINATE (NCT04262492)
- Testing
- Rivaroxaban
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Stéphane Zuily
Antiphospholipid Syndrome (APS)
Follow-up Cohort of Patients With Antiphospholipid Syndrome
Antiphospholipid syndrome (APLS) is a rare pathology characterized by the association of thrombotic (arterial, venous) or obstetric clinical manifestations and the persistent presence at least twelve weeks apart of…
- Trial name
- ReLaps (NCT07178925)
- Testing
- Study of Antiphospholipid Syndrome responding to the Sydney classification of 2006
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Rouen
Antiphospholipid Syndrome
Rivaroxaban in Thrombotic Antiphospholipid Syndrome
Primary Study Objective(s) The primary objective is to demonstrate the non-inferiority of Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR 2.0-3.0) with respect to the occurrence of the…
- Trial name
- TRAPS (NCT02157272)
- Testing
- Experimental: Rivaroxaban
- Where
- Italy
- Volunteers
- 121 people
- Sponsor
- University of Padova
Primary Antiphospholipid Syndrome
Hydroxychloroquine Versus Placebo: Impact on Thrombotic Relapse in Primary Antiphospholipid Syndrome
Antiphospholipid syndrome (APS) combines thrombotic (venous and/or arterial) and/or obstetrical manifestations, along with biological anomalies related to the presence of antiphospholipid antibodies.
- Trial name
- PAPIRUS (NCT03540810)
- Testing
- Hydroxychloroquine
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Angers
Systemic Lupus Erythematosus, Idiopahic Inflammatory Myopathies
A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases
The purpose of this study is to assess the safety and efficacy of CD19 UCAR-T cell therapy in Subjects with autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome
- Trial name
- ET-902-AID01 (NCT07212322)
- Testing
- CD19 UCAR-T cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing…
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM)
- Trial name
- NCT06723106
- Testing
- RAY121
- Where
- 62 sites in Australia, Austria and 17 more
- Volunteers
- 144 people
- Sponsor
- Chugai Pharmaceutical