Clinical trials: Idiopathic Inflammatory Myositis
Dermatomyositis
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.
- Trial name
- NCT05192200
- Testing
- Anti-Beta Interferon (PF-06823859)
- Where
- 25 sites in United States, Hungary and 2 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Dermatomyositis, Idiopathic Inflammatory Myopathies
Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis
Background: Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis.
- Trial name
- NCT03267277
- Testing
- Sodium Thiosulfate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Inclusion Body Myositis
A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
- Trial name
- NCT05721573
- Testing
- ABC008
- Where
- 45 sites in United States, Australia and 5 more
- Volunteers
- 272 people
- Sponsor
- Abcuro, Inc.
Myositis, Inflammatory
Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions
Background: Inflammation plays a significant role in various disorders that involve neurodegeneration or autoimmune reaction as one of their mechanisms. PET scans can help detect inflammation.
- Conditions
- Myositis, Inflammatory, Rheumatoid Arthritis, Healthy Volunteers
- Trial name
- NCT03912428
- Testing
- 11C-MC1, Celecoxib, [11C]ER176
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- National Institute of Mental Health (NIMH)
Polymyositis, Dermatomyositis
A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active polymyositis (PM)/dermatomyositis (DM) despite receiving 1 or more standard-of-care treatments (for example, glucocorticoids and/or…
- Trial name
- NCT03981744
- Testing
- Ustekinumab 6 mg/kg, Ustekinumab 90 mg
- Where
- 32 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Janssen Pharmaceutical K.K.
Polymyositis, Dermatomyositis
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with KZR-616 in patients…
- Trial name
- PRESIDIO (NCT04033926)
- Testing
- KZR-616
- Where
- 14 sites in United States, Czechia and 1 more
- Volunteers
- 25 people
- Sponsor
- Kezar Life Sciences, Inc.
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.
Local Anesthetic Complication, Local Anesthetic Drug Adverse Reaction
Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty
The aim of this study was to describe the postoperative "baseline" magnetic resonance imaging (MRI) appearance of the ipsilateral thigh musculature after total knee arthroplasty (TKA).
- Trial name
- NCT04821245
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Benaroya Research Institute
Musculoskeletal Infection, Acute Hematogenous Osteomyelitis
Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections
The purpose of this study is to evaluate the use of a blood test: Karius® plasma-based next-generation sequencing test (Karius Test), to see if we can detect and measure the infection causing agent in children with…
- Conditions
- Musculoskeletal Infection, Acute Hematogenous Osteomyelitis, Septic Arthritis, Osteomyelitis
- Trial name
- KDG-002 (NCT03846804)
- Testing
- Karius Test
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Indiana University
Idiopathic Inflammatory Myositis
A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)
The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1.
- Trial name
- NCT05669014
- Testing
- Daxdilimab
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 12 people
- Sponsor
- Amgen
Myopathy, Myositis
Ultrasound in Muscle Biopsy
The objective of the proposed study is to evaluate the clinical utility of muscle ultrasonography for improving the diagnostic yield and safety of core muscle biopsy.
- Conditions
- Myopathy, Myositis, Muscular Dystrophy
- Trial name
- NCT01790178
- Testing
- Ultrasound
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Duke University
Polymyositis
Efficacy and Tolerability of BAF312 in Patients With Polymyositis
This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids…
- Trial name
- NCT01801917
- Testing
- BAF312
- Where
- 8 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Inclusion Body Myositis
Study of Arimoclomol in Inclusion Body Myositis (IBM)
Funding Source - FDA Office of Orphan Products Development (OOPD). The purpose of this study is to evaluate the safety and efficacy of the study drug, arimoclomol in IBM patients.
- Trial name
- NCT02753530
- Testing
- Arimoclomol
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 152 people
- Sponsor
- ZevraDenmark
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to…
- Trial name
- MOVE (NCT03312634)
- Testing
- Palovarotene
- Where
- 16 sites in United States, Argentina and 9 more
- Volunteers
- 107 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Dermatomyositis
Abatacept in Juvenile Dermatomyositis
The purpose of this study is to assess the safety and efficacy of subcutaneous abatacept in 10 patients seven years of age and older with refractory JDM.
- Trial name
- AID (NCT02594735)
- Testing
- Abatacept
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- George Washington University
MYOPATHY
Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases
Myositis is a disease, believed to be due to immune cells, cells which normally protect the body, but are now attacking the muscles and other organ systems within body.
- Trial name
- NCT00278564
- Testing
- Hematopoietic stem cell transplantation, Cyclophosphamide, Mesna
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Northwestern University
Sporadic Inclusion Body Myositis
An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis.
- Trial name
- NCT02573467
- Testing
- Bimagrumab
- Where
- 38 sites in United States, Australia and 8 more
- Volunteers
- 211 people
- Sponsor
- Novartis Pharmaceuticals
Inclusion Body Myositis
Arimoclomol in Sporadic Inclusion Body Myositis
Inclusion body myositis (IBM) is the most common progressive and debilitating muscle disease beginning in persons over 50 years of age.
- Trial name
- NCT00769860
- Testing
- Arimoclomol
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 24 people
- Sponsor
- Richard Barohn, MD
Sporadic Inclusion Body Myositis (sIBM)
Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
This study is an open-label, long-term study for those patients who participated in the prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM was demonstrated after a single 30 mg/kg…
- Trial name
- BYM338 (NCT02250443)
- Testing
- BYM338 (Bimagrumab)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Sporadic Inclusion Body Myositis
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic…
- Trial name
- RESILIENT (NCT01925209)
- Testing
- BYM338/bimagrumab
- Where
- 38 sites in United States, Australia and 8 more
- Volunteers
- 251 people
- Sponsor
- Novartis Pharmaceuticals