Phase 3 N=24 Arimoclomol in Sporadic Inclusion Body Myositis
Inclusion Body Myositis
Primary: Count of Adverse Events Reported — 109; 52 adverse events reported
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=152 Study of Arimoclomol in Inclusion Body Myositis (IBM)
Inclusion Body Myositis
Primary: Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score — -3.26; -2.26 score on a scale — p=0.1146
Phase 3 N=10 Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
Sporadic Inclusion Body Myositis (sIBM)
Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 0; 2; 10 Participants
Phase 3 N=211 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
Sporadic Inclusion Body Myositis
Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths. — 48; 50; 44; 49 Participants
Phase 3 N=251 Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
Sporadic Inclusion Body Myositis
Primary: Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52 — 8.63; 9.63; -10.27; -8.96 meters — p=0.2210
Phase 3 N=17 Belimumab in Idiopathic Inflammatory Myositis
Myositis
Primary: Response Rate During Randomized Phase — 3; 1; 5; 2 Participants — p=0.60
Phase 3 N=148 Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
Polymyositis · Dermatomyositis · Autoimmune Necrotizing Myopathy
Primary: Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue — 42; 31…
Phase 2 N=17 Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)
Myotonic Dystrophy
Primary: The Number of Study Participants Who Safely Tolerated Somatokine — 6; 9 participants
Phase 2 N=75 A Study In Adults With Moderate To Severe Dermatomyositis
Dermatomyositis
Primary: Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) — -3.44…
Phase 2 N=9 Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Multiple System Atrophy
Primary: Number of Adverse Events up to Six Months Post-treatment — 43; 0 Adverse events
Phase 3 N=95 Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Dermatomyositis
Primary: Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) — 21; 37 Participants
Phase 2 N=36 Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis
Dermatomyositis · Polymyositis
Primary: Compare the Average Total Improvement Scores at Visits 2 Through 7 During the 6-month Treatment Period Between the Treatment and Placebo Arms — 26.4; 29.3 score on a…
Phase 2 N=69 Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1
Myotonic Dystrophy Type 1
Primary: Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) Distance — 12.40; 20.11 meters
Phase 2 N=20 Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease
Myositis · Interstitial Lung Disease
Primary: % Predicted Forced Vital Capacity (FVC) Absolute Change — -1.70; -2.05 % predicted FVC — p=<0.05
Phase 2 N=19 A Trial of PF-06252616 in Ambulatory Participants With LGMD2I
LGMD2I
Primary: Incidence of Dose Limiting or Intolerability Treatment Related Adverse Events — 45; 21; 40; 0 events
Phase 3 N=25 Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus
Interstitial Pneumonitis · Polymyositis · Dermatomyositis
Primary: Overall Survival — 88.0 percentage of participants
N/A N=22 Regulation of Muscle Protein Phenotype in Humans With Obesity
Obesity
Primary: Whole-Muscle Protein Synthesis — 0.004; 0.015 %/hr
N/A N=25 Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients
Idiopathic Pulmonary Fibrosis
Primary: 6 Minute Walk Distance — -6.2; -15.3 meters
Phase 2 N=30 Trial of IMO-8400 in Adult Patients With Dermatomyositis
Dermatomyositis
Primary: To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM — 6; 4; 2; 4 participants
Phase 3 N=89 Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sialic Acid in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)
Hereditary Inclusion Body Myopathy · Distal Myopathy With Rimmed Vacuoles · Distal Myopathy, Nonaka Type
Primary: Change From Baseline in UEC Score (Total Force in kg) at Week 48 — -2.25; -2.99 kg — p=0.5387
N/A N=89 Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials
Amyotrophic Lateral Sclerosis
Primary: Electrical Impedance Myography — 0.55 Coefficient of Variation
Phase 2 N=5 ACTIMMUNE in Intermediate Osteopetrosis
Osteopetrosis
Primary: Number of Participants With Treatment Related Adverse Events CTCAE v4.0 Grade 3 or Higher — 0 Participants
N/A N=99 Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise
Stroke · Inflammation
Primary: Cardiovascular Fitness (VO2 Peak) — 15.9; 16.6; 21.3; 17.5 ml/kg/min — p=0.001
Phase 2 N=25 A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
Polymyositis · Dermatomyositis
Primary: Mean Change in the Total Improvement Score (TIS) From Start to End of Zetomipzomib (KZR-616) Treatment Period — 25.5; 25.0; 33.1; 33.5 score on a scale
Phase 2 N=63 Antioxidant Therapy in RYR1-Related Congenital Myopathy
Neuromuscular Disease
Primary: Urine 15-F2t Isoprostane Concentration — 2.7; 2.6 ng/mg Cr — p=0.88
Phase 2 N=10 Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
Multiple Myeloma · Plasma Cell Neoplasm
Primary: Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One…
Phase 2 N=51 Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate
Scleroderma, Systemic · Interstitial Lung Disease
Primary: Percent Predicted Forced Vital Capacity (FVC-%) — 2.24; 2.09 percent predicted — p=0.9326
Phase 3 N=330 Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial
Amyotrophic Lateral Sclerosis
Primary: Rate of Change in Composite Manual Muscle Testing (MMT) Score — 0.44; 0.39 MMT units per month — p=0.529
Phase 2 N=200 Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)
Myositis · Dermatomyositis · Polymyositis
Primary: Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients — 20.2; 20.0 Weeks — p==0.74
Phase 3 N=39 Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy
Glomerulonephritis, Membranous
Primary: Percentage of Complete Remission — 4; 3 Participants