Clinical trials: Idiopathic Inflammatory Myopathies(IIM)
Inflammatory Myopathy
Renal Manifestations During Idiopathic Inflammatory Myopathies
There are currently no recommendations regarding treatments for Idiopathic Inflammatory Myopathies (IIM) due to the difficulty in conducting high-powered randomized controlled trials.
- Trial name
- IIM (NCT06904937)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Strasbourg, France
Myositis, Idiopathic Inflammatory Myopathy
MYOPROSP - a Prospective Cohort Study in Myositis
Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and…
- Trial name
- MYOPROSP (NCT02468895)
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- University of Manchester
Idiopathic Inflammatory Myopathy
A Case-control Study to Assess Risk of Coronary Heart Disease in Idiopathic Inflammatory Myopathy
This study will be co-ordinated by Dr Hector Chinoy, Dr Robert G Cooper (Salford Royal NHS Foundation Trust / The University of Manchester) and Dr Ian N Bruce (Central Manchester University Hospitals NHS Foundation Trust/ The…
- Trial name
- NCT00971828
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Northern Care Alliance NHS Foundation Trust
Idiopathic Inflammatory Myopathies
Optimizing Treatment on Idiopathic Inflammatory Myopathies
As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset.
- Trial name
- NCT03092180
- Testing
- Intravenous Infusion
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- University of Sao Paulo
Idiopathic Inflammatory Myopathy, Interstitial Lung Disease
Clinical Study of MMF in Treatment of IIM-ILD and Its Effect on Peripheral Blood Treg Cells
Interstitial lung disease (ILD) is a common pulmonary manifestation of idiopathic inflammatory myopathy (IIM). The overall 5-year mortality is 50%.
- Trial name
- NCT05129410
- Testing
- Mycophenolate Mofetil
- Where
- China
- Volunteers
- 20 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Idiopathic Inflammatory Myopathies, ANCA-Associated Vasculitis
Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of IIM and AAV
This is an open-label, investigator-initiated clinical trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with refractory IIM and AAV.
- Trial name
- NCT06986018
- Testing
- RD06-04 Cell Injection Infusion
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Peking University People's Hospital
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
- Trial name
- NCT05869955
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 46 sites in United States, Belgium and 4 more
- Volunteers
- 270 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Myositis
Belimumab in Idiopathic Inflammatory Myositis
The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care.
- Trial name
- BIM (NCT02347891)
- Testing
- Belimumab
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Northwell Health
Dermatomyositis
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
- Trial name
- IIM (NCT02728752)
- Testing
- Octagam 10%
- Where
- 37 sites in United States, Canada and 8 more
- Volunteers
- 95 people
- Sponsor
- Octapharma
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome
- Trial name
- NCT06417398
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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
Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV)
IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV)…
- Conditions
- Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM)
- Trial name
- NCT06462144
- Testing
- IMPT-514 CART Cell Injection
- Where
- 3 sites in China
- Volunteers
- 3 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Myositis
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM).
- Trial name
- NCT05895786
- Testing
- PF-06823859
- Where
- 138 sites in United States, Argentina and 18 more
- Volunteers
- 318 people
- Sponsor
- Pfizer
Inflammatory Myositis, Idiopathic Inflammatory Myositis
Clinical Database and Biobank of Patients With Inflammatory Myopathies: the MASC Project (Myositis, DNA, Serum, Cells) (MASC)
Myositis are rare diseases for which the development of a cohort associated with a bank of biological samples (biobank) will allow for the conduct of researches to better delineate the underlying pathophysiology and find cures.
- Conditions
- Inflammatory Myositis, Idiopathic Inflammatory Myositis, Drug-induced Inflammatory Myositis
- Trial name
- MASC (NCT04637672)
- Where
- France
- Volunteers
- 1,273 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Idiopathic Inflammatory Myopathies
Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies
1. To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs). 2. To assess whether EIM parameters are reflective of disease severity, based on clinical outcome measures of IIMs.
- Trial name
- NCT03918356
- Testing
- electrical impedance myography, healthy control group
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Yale University
Rheumatic Diseases, Rheumatoid Arthritis (RA)
Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy
The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases.
- Conditions
- Rheumatic Diseases, Rheumatoid Arthritis (RA), Giant Cell Arteritis (GCA), Psoriatic Arthritis (PsA)
- Trial name
- CARe RAiSE (NCT07150000)
- Testing
- Ex Vivo Assay
- Where
- Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Bonn
Autoimmune Diseases, SLE - Systemic Lupus Erythematosus
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases
This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell…
- Conditions
- Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies
- Trial name
- NCT07674147
- Testing
- RD06-05 CART Cell Infusion
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Study of AZD0120 in Autoimmune Diseases
This trial is a Phase 1b/2, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc)…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
- Trial name
- AURORA (NCT07295847)
- Testing
- AZD0120, SOC
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 27 people
- Sponsor
- AstraZeneca