Clinical trials: Systemic Lupus
REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA.
- Trial name
- SELECT-SLE (NCT07523542)
- Testing
- Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg)., Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Beijing Biotech
Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric…
- Trial name
- VOCAL-EXT (NCT05962788)
- Testing
- voclosporin
- Where
- 6 sites in United States, Colombia and 3 more
- Volunteers
- 4 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Systemic Lupus Erythematosus
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus
- Trial name
- NCT06711146
- Testing
- Metabolically Armed CD19 CAR-T cells
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Zhejiang University
Systemic Lupus Erythematosus
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects.
- Trial name
- NCT06657703
- Testing
- HC022
- Where
- 3 sites in China
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- HC Biopharma Inc.
Lupus Erythematosus, Systemic
NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of…
- Trial name
- VIOLET (NCT07424261)
- Where
- 21 sites in Germany
- Volunteers
- 125 people
- Sponsor
- AstraZeneca
Lupus Nephritis
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
This is an exploratory study. No formal hypothesis will be tested. The objectives of this study are to follow Lupus Nephritis patients over a period of 12 months to: Establish the baseline biomarker characteristics of patients…
- Trial name
- NCT01470183
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Columbia University
Congenital Heart Block, Neonatal Lupus
Preventive Approach to Congenital Heart Block With Hydroxychloroquine
Women with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a child with a life threatening heart condition regardless of whether they have very active lupus, are in remission, or have only vague…
- Conditions
- Congenital Heart Block, Neonatal Lupus, Autoantibody-Associated Heart Block
- Trial name
- PATCH (NCT01379573)
- Testing
- Hydroxychloroquine
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- NYU Langone Health
Metabolic Syndrome, Cardiovascular Risk Factors
A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus
An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.
- Conditions
- Metabolic Syndrome, Cardiovascular Risk Factors, Systemic Lupus Erythematosus
- Trial name
- NCT00982670
- Where
- Taiwan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Far Eastern Memorial Hospital
Systemic Lupus, Rheumatoid Arthritis
Yellow Fever Vaccine in Patients With Rheumatic Diseases
According to World Health Organization (WHO), since December 2016, Brazil is showing a significant increase in cases of yellow fever in humans.
- Conditions
- Systemic Lupus, Rheumatoid Arthritis, Spondyloarthritis, Inflammatory Myopathy
- Trial name
- NCT03430388
- Testing
- Yellow Fever vaccine (17D)
- Where
- Brazil
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Lupus Erythematosus, Systemic
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in…
- Trial name
- NCT02349061
- Testing
- Ustekinumab IV, Ustekinumab SC, Concomitant Medication
- Where
- 43 sites in United States, Argentina and 7 more
- Volunteers
- 102 people
- Sponsor
- Janssen Research & Development, LLC
Lupus Nephritis
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)
This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.
- Trial name
- NCT02550652
- Testing
- Mycophenolate Mofetil/Mycophenolic Acid, Obinutuzumab, Methylprednisolone
- Where
- 46 sites in United States, Argentina and 10 more
- Volunteers
- 126 people
- Sponsor
- Hoffmann-La Roche
Systemic Lupus Erythematosus
The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
The goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity.
- Trial name
- SAGE (NCT00671047)
- Testing
- non-interventional
- Where
- 12 sites in United States, Canada
- Volunteers
- 1,000 people
- Sponsor
- XDx
Systemic Lupus Erythematosus, Ketogenic Dieting
The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity
The study investigates the dietary habits in relation to low doses of omega-3 fatty acids in subcutaneous adipose tissue, disease activity and atherosclerosis.
- Trial name
- NCT05689580
- Testing
- Ketogenic diet, Balanced diet
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Chang Gung Memorial Hospital
Systemic Lupus Erythematosus, Lupus Nephritis
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06544330
- Testing
- SYNCAR-001, STK-009
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Synthekine
Inflammatory Arthritis, Scleroderma
Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases
This study will assess the effect of a mindfulness meditation program administered via a smartphone application on health-related quality of life for patients with rheumatic disease.
- Conditions
- Inflammatory Arthritis, Scleroderma, Myositis, Sjogren's Syndrome
- Trial name
- NCT03937856
- Testing
- Calm- Mindfulness Meditation smartphone application
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Johns Hopkins University
Lupus or SLE, Interstitial Lung Disease
Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease
Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and…
- Conditions
- Lupus or SLE, Interstitial Lung Disease, Systemic Lupus Erythematosus
- Trial name
- NCT07077486
- Testing
- Methylprednisolone (Corticosteroid), Immunosuppressant other than CYC, Telitacicept Freeze-dried powder Injection 80mg
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
Lupus Nephritis
Pentoxifylline in Lupus Nephritis
Glomerulonephritis is an important manifestation in about 1/2 of patients with Systemic Lupus Nephritis (SLE; lupus). Despite recent national guidelines recommending use of induction therapy with high-dose corticosteroids and…
- Trial name
- Pentoxifylline (NCT03859570)
- Testing
- Pentoxifylline
- Where
- United States
- Sponsor
- MetroHealth Medical Center
Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator…
- Trial name
- ROSY-S (NCT07691970)
- Testing
- Anifrolumab
- Where
- 153 sites in United States, Argentina and 33 more
- Volunteers
- 1,072 people
- Sponsor
- AstraZeneca
Optic Neuritis, Transverse Myelitis
Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)
The Swiss-Ped-IBrainD is a national patient registry that collects information on diagnosis, symptoms, treatment, and follow-up of pediatric patients with an inflammatory brain disease in Switzerland.
- Conditions
- Optic Neuritis, Transverse Myelitis, Acute Disseminated Encephalomyelitis, Multiple Sclerosis
- Trial name
- NCT05017142
- Where
- 13 sites in Switzerland
- Volunteers
- 500 people
- Sponsor
- University of Bern
Lupus Erythematosus, Systemic
Effect of Qi Gong Training on Quality of Life in Patients With Systemic Lupus Erythematous (LuQi)
Systemic Lupus Erythematosus (SLE) is chronic and systemic autoimmune disease that mainly affecting women and leading to organ damages especially skin, joints, kidneys, central nervous system and heart.
- Trial name
- LuQi (NCT02732470)
- Testing
- Qi Gong
- Where
- France
- Volunteers
- 33 people
- Sponsor
- University Hospital, Limoges
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