Clinical trials: Systemic Autoimmune Disease
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis…
- Conditions
- Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus
- Trial name
- EMERALD (NCT05001737)
- Testing
- Emapalumab
- Where
- 44 sites in United States, Belgium and 11 more
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Autoimmune Pancytopenia, Autoimmune Lymphoproliferative Syndrome (ALPS)
Sirolimus for Autoimmune Disease of Blood Cells
Treatment for patients with autoimmune destruction of blood cells is poor. The part of the body that fights infections is called the immune system and white blood cells (WBCs) are part of the immune system.
- Conditions
- Autoimmune Pancytopenia, Autoimmune Lymphoproliferative Syndrome (ALPS), Evans Syndrome, Idiopathic Thrombocytopenic Purpura
- Trial name
- NCT00392951
- Testing
- sirolimus
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Children's Hospital of Philadelphia
Wegener's Granulomatosis
Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis
Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or vasculitis. It may involve many different parts of the body, but typically affects the upper and lower respiratory tract and kidneys.
- Trial name
- NCT00468208
- Testing
- Abatacept
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Pennsylvania
Lupus Erythematosus, Systemic
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of…
- Trial name
- VOYAGER (NCT00381810)
- Testing
- Rituximab, Methylprednisolone, Acetaminophen
- Where
- 11 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus
A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
The purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription.
- Trial name
- SLE (NCT01689350)
- Testing
- Genotype Detection
- Where
- China
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
NUCALA® Special Drug Use Investigation (EGPA, Long-term)
This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in…
- Trial name
- NCT03557060
- Testing
- Nucala
- Where
- Japan
- Volunteers
- 4,115 people
- Sponsor
- GlaxoSmithKline
Lupus Nephritis
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids.
- Trial name
- NCT00573157
- Testing
- Atacicept, Mycophenolate mofetil, Corticosteroids
- Where
- 20 sites in United States, Czechia and 3 more
- Volunteers
- 6 people
- Sponsor
- EMD Serono
Systemic Lupus Erythematosus
A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus
This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study…
- Trial name
- NCT05917288
- Testing
- Belimumab, Standard of care
- Where
- 6 sites in China
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus, Systemic Sclerosis
Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors)…
- Trial name
- NCT00684255
- Testing
- Reduced Intensity Allogeneic Transplant, Fludarabine, Busulfan
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- New York Medical College
Systemic Juvenile Idiopathic Arthritis
An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.
This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with…
- Trial name
- β-SPECIFIC 3 (NCT00891046)
- Testing
- Canakinumab
- Where
- 73 sites in United States, Argentina and 19 more
- Volunteers
- 270 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus (SLE), Juvenile SLE
Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases
No drug treatment is completely free of risk and lack of response, adverse events and poor adherence may affect its effectiveness.
- Conditions
- Systemic Lupus Erythematosus (SLE), Juvenile SLE, Cutaneous Lupus
- Trial name
- NCT03122431
- Testing
- Thalidomide, Hydroxychloroquine reduced, standard dose of HCQ
- Where
- Brazil
- Volunteers
- 93 people
- Sponsor
- University of Sao Paulo General Hospital
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Systemic Juvenile Idiopathic Arthritis
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile…
- Trial name
- NCT02396212
- Testing
- Canakinumab
- Where
- 7 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Erythematosus, Systemic
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2.
- Trial name
- NCT00065806
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 221 people
- Sponsor
- Laura Schanberg
Juvenile Idiopathic Arthritis
Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults
Systemic juvenile idiopathic arthritis (SJIA) is a type of arthritis that typically occurs before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the body's joints.
- Trial name
- NCT00534495
- Testing
- Rilonacept
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Montefiore Medical Center
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease…
- Trial name
- PHOENYCS GO (NCT04294667)
- Testing
- DZP
- Where
- 177 sites in United States, Argentina and 23 more
- Volunteers
- 321 people
- Sponsor
- UCB Biopharma SRL
Juvenile Idiopathic Arthritis
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids.
- Trial name
- NCT00642460
- Testing
- tocilizumab [RoActemra/Actemra], Non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate
- Where
- 54 sites in United States, Argentina and 17 more
- Volunteers
- 112 people
- Sponsor
- Hoffmann-La Roche
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
- Trial name
- NCT03517722
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 mg
- Where
- 204 sites in United States, Argentina and 18 more
- Volunteers
- 516 people
- Sponsor
- Janssen Research & Development, LLC
Systemic Lupus Erythematosus
Study of Anti-Malarials in Incomplete Lupus Erythematosus
This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial that is designed to test whether treating patients who are at risk for development of lupus with hydroxychloroquine can slow accumulation…
- Trial name
- SMILE (NCT03030118)
- Testing
- Hydroxychloroquine
- Where
- 7 sites in United States
- Volunteers
- 187 people
- Sponsor
- Milton S. Hershey Medical Center
Granulomatosis With Polyangiitis
A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA)…
- Trial name
- NCT01750697
- Testing
- Rituximab
- Where
- 23 sites in United States, Canada and 6 more
- Volunteers
- 25 people
- Sponsor
- Hoffmann-La Roche