Clinical trials: Idiopathic Inflammatory Myopathies
Arthritis, Juvenile, Arthritis, Juvenile Idiopathic
Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting
The proposed study aims to evaluate the effectiveness of hypnotherapy as a non-pharmacological intervention for managing pain and anxiety during needle-related medical procedures in children aged 5 to 17 years.
- Conditions
- Arthritis, Juvenile, Arthritis, Juvenile Idiopathic, Lupus Erythematosus, Systemic, Dermatomyositis, Juvenile
- Trial name
- NCT07349667
- Testing
- Hypnotherapy
- Where
- Denmark
- Volunteers
- 70 people
- Sponsor
- Aarhus University Hospital
Polymyositis, Dermatomyositis
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to…
- Trial name
- NCT04628936
- Testing
- KZR-616
- Where
- 10 sites in United States, Czechia
- Volunteers
- 18 people
- Sponsor
- Kezar Life Sciences, Inc.
Muscular Dystrophies, Congenital Myopathy
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
The aims of the current study are as follow: i) Evaluate the safety, usability, and acute efficiency of a powered knee-hip dermoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland) in patients with neuromuscular disorders, ii)…
- Conditions
- Muscular Dystrophies, Congenital Myopathy, Idiopathic Inflammatory Myopathies, Mitochondrial Myopathies
- Trial name
- Exo-NMD1 (NCT05200702)
- Testing
- Knee-hip Powered Soft Exoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland)
- Where
- France
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Institut de Myologie, France
Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis
Transition to Adulthood Through Coaching and Empowerment in Rheumatology
TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.
- Conditions
- Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis, Juvenile Dermatomyositis, Juvenile Psoriatic Arthritis
- Trial name
- TRACER (NCT05545839)
- Testing
- Transition coaching
- Where
- 2 sites in Canada
- Volunteers
- 26 people
- Sponsor
- McMaster University
Rheumatoid Arthritis, Spondylitis, Ankylosing
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary…
- Conditions
- Rheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis, Systemic Lupus Erythematosus
- Trial name
- RZVRheum (NCT05879419)
- Testing
- Recombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation, MMF Discontinuation
- Where
- Brazil
- Volunteers
- 2,005 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Myositis, Dermatomyositis
High-intensity Strength Training in Myositis
This study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36).
- Conditions
- Myositis, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy
- Trial name
- HI-STIM (NCT04486261)
- Testing
- High-intensity strength training
- Where
- Denmark
- Volunteers
- 34 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Dry Syndrome, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06970951
- Testing
- UTAA91 injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Systemic Lupus Erythematosus, Lupus Nephritis
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- BAH242 (NCT06350110)
- Testing
- CD19- BCMA CAR-T cells
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Essen Biotech
Inflammatory Myopathy, Idiopathic, Dermatomyositis
Add-on Intravenous Immunoglobulins in Early Myositis
In patients with myositis early immunomodulation by intensive treatment ("hit-early/hit-hard" principle) may induce faster reduction of disease activity and prevent chronic disability.
- Conditions
- Inflammatory Myopathy, Idiopathic, Dermatomyositis, Antisynthetase Syndrome, Immune-Mediated Necrotizing Myopathy
- Trial name
- TIMEISMUSCLE (NCT05832034)
- Testing
- Immune Globulin Intravenous (Human)
- Where
- Netherlands
- Volunteers
- 44 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Idiopathic Inflammatory Myopathies, Inflammatory Myopathies
A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies.
- Trial name
- NCT06524687
- Testing
- Imvotamab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- IGM Biosciences, Inc.
Dermatomyositis, Polymyositis
Adult and Juvenile Myositis
This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them.
- Conditions
- Dermatomyositis, Polymyositis, Inclusion Body Myositis
- Trial name
- NCT00017914
- Where
- 4 sites in United States
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Antisynthetase Syndrome
Association Between Cancer and Anti-synthetase Syndrome
Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might…
- Trial name
- NCT04941547
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Central Hospital, Nancy, France
Myositis, Idiopathic Inflammatory Myopathies
Characterizing Myositis With 68Ga-FAPI PET/CT
To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis and evaluation of systemic involvement in idiopathic inflammatory myopathies (IIM)/myositis, and compared the results with those of 18F-FDG PET/CT.
- Trial name
- NCT05952531
- Testing
- 68Ga-FAPI
- Where
- China
- Volunteers
- 50 people
- Sponsor
- The First Affiliated Hospital of Xiamen University
Inflammatory Rheumatism, Polymyalgia Rheumatica
PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy.
- Conditions
- Inflammatory Rheumatism, Polymyalgia Rheumatica, Giant Cell Arteritis, Idiopathic Inflammatory Myopathies
- Trial name
- PRODIGIOUS (NCT04664465)
- Where
- 12 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Brest
Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases.
- Conditions
- Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis, SLE Nephritis, ANCA Associated Vasculitis
- Trial name
- CARTIMMUNE (NCT06152172)
- Testing
- KYV-101, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- David Porter
SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
- Conditions
- SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis (AAV)
- Trial name
- NCT07315087
- Testing
- QT-019C
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Myositis
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
- Trial name
- SPIREA (NCT05379634)
- Testing
- Nipocalimab, Glucocorticoids
- Where
- 57 sites in United States, Canada and 11 more
- Volunteers
- 36 people
- Sponsor
- Janssen Research & Development, LLC
Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP)
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in…
- Conditions
- Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP), Systemic Lupus Erythematosus(SLE)
- Trial name
- NCT07174843
- Testing
- CD19/CD22/BCMA CAR-T cells(BZE2204)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, Rheumatoid Arthritis
- Trial name
- NCT06733935
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.