| 1 |
NCT01801917 |
Terminated
Has Results |
Efficacy and Tolerability of BAF312 in Patients With Polymyositis |
|
- Drug: Placebo
- Drug: BAF312
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline at Week 12 for BAF312 2 mg, 10 mg or Placebo (Once Daily) for Combined Efficacy Endpoint: Manual Muscle Testing in 24 Muscles (MMT24)
- Percent Change From Baseline at Week 12 for BAF312 2 mg, 10 mg or Placebo (Once Daily) Serum Creatine Kinase (CK) Levels
- Six-minute Walking Distance (6MWD) at Week 12
- (and 2 more...)
|
14 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01801917 |
CBAF312X2205 |
|
April 24, 2013 |
August 5, 2016 |
August 5, 2016 |
March 1, 2013 |
January 4, 2018 |
January 4, 2018 |
- Novartis Investigative Site
Phoenix, Arizona, United States - Novartis Investigative Site
Torono, Ontario, Canada - Novartis Investigative Site
Prague 2, Czechia - (and 5 more...)
|
| 2 |
NCT01906372 |
Completed
Has Results |
Acthar in Treatment of Refractory Dermatomyositis and Polymyositis |
- Dermatomyositis
- Polymyositis
|
- Drug: Adrenocorticotropic Hormone Gel
|
Interventional |
Phase 2 |
- Rohit Aggarwal, MD
- Mallinckrodt
- University of Pittsburgh
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).
- Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients.
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT01906372 |
PRO13050507 |
|
September 2013 |
September 2015 |
May 2016 |
July 24, 2013 |
September 1, 2017 |
August 2, 2017 |
- North Shore LIJ Medical Center
Great Neck, New York, United States - University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
| 3 |
NCT02043548 |
Recruiting |
Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis |
- Dermatomyositis
- Polymyositis
|
- Drug: tocilizumab
- Drug: placebo
|
Interventional |
Phase 2 |
- University of Pittsburgh
- Genentech, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Proportion of subjects meeting the definition of improvement (DOI)
- Comparison of the time to first DOI between the 2 arms
- frequency of defined adverse events between the treatment and placebo arms.
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02043548 |
0039599 |
TIM |
October 1, 2014 |
July 30, 2018 |
January 31, 2019 |
January 23, 2014 |
November 1, 2017 |
|
- Cedars Sinai Medical Center
Los Angeles, California, United States - University of Kansas Medical Center
Kansas City, Kansas, United States - Mayo Clinic
Rochester, Minnesota, United States - (and 4 more...)
|
| 4 |
NCT01813617 |
Completed |
Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis |
- Polymyositis
- Dermatomyositis
|
- Drug: Immunosuppressive Agents
|
Observational |
|
- Karolinska University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Functional Index 2 assessing change in muscle function over time.
- Manual Muscle test, MMT-8, assessing change in muscle function over time.
|
72 |
All |
18 Years and older (Adult, Senior) |
NCT01813617 |
SweMyoNet 1
Centre of Care Science |
|
September 2010 |
June 2012 |
|
March 19, 2013 |
March 19, 2013 |
|
- Karolinska University Hospital, Solna
Stockholm, Sweden
|
| 5 |
NCT02880527 |
Completed |
Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy |
- Polymyositis
- Dermatomyositis
|
- Other: Patients with polymyositis / dermatomyositis
|
Observational |
|
- University Hospital, Rouen
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Confirmed diagnosis of polymyositis / dermatomyositis
|
187 |
All |
18 Years and older (Adult, Senior) |
NCT02880527 |
2013/007/HP |
EPIDEMYOSITIS |
July 2014 |
April 2016 |
May 2016 |
August 26, 2016 |
August 26, 2016 |
|
- Rouen University Hospital
Rouen, France
|
| 6 |
NCT03324152 |
Not yet recruiting |
Effects of High-intensity Interval Training (HIIT) in Recent Onset Polymyositis and Dermatomyositis |
- Polymyositis
- Dermatomyositis
|
- Other: High-intensity interval training (HIIT) - myositis
- Other: Standard low-intensity home exercise
- Other: High-intensity interval training (HIIT) - healthy
|
Interventional |
Not Applicable |
- Karolinska University Hospital
- Karolinska Institutet
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Isometric muscle strength
- Isometric muscle endurance
- VO2max, L/min
- (and 24 more...)
|
30 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03324152 |
KarolinskaUH1 |
HIITmyositis |
November 1, 2017 |
December 31, 2020 |
December 31, 2021 |
October 27, 2017 |
October 27, 2017 |
|
|
| 7 |
NCT00533091 |
Completed |
A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis |
- DERMATOMYOSITIS OR POLYMYOSITIS
|
- Biological: MEDI-545
- Other: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The primary endpoints of the study are safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with Dermatomyositis or Polymyositis, assessed primarily by summarizing AEs assessing changes in viral cultures and titers.
- The secondary endpoints of the study are the PK and IM of multiple IV doses of MEDI-545.
- The third endpoint of the study are the evaluations of disease activities.
|
51 |
All |
18 Years and older (Adult, Senior) |
NCT00533091 |
MI-CP151 |
|
April 2008 |
August 2010 |
October 2010 |
September 21, 2007 |
May 28, 2012 |
|
- Research Site
Scottsdale, Arizona, United States - Research Site
Stanford, California, United States - Research Site
Whittier, California, United States - (and 11 more...)
|
| 8 |
NCT01637064 |
Unknown † |
Dermatomyositis and Polymyositis Registry |
- Dermatomyositis
- Polymyositis
|
|
Observational |
|
- Phoenix Neurological Associates, LTD
|
Other |
- Observational Model: Case-Only
|
- Determining if Acthar treatment improves disease progression
- Subgroups may predict response to Acthar therapy
|
100 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT01637064 |
ADAPT |
ADAPT |
April 2013 |
December 2015 |
|
July 10, 2012 |
November 6, 2015 |
|
- PNA Center for Neurological Research
Phoenix, Arizona, United States - Ara Dikranian MD
San Diego, California, United States - Neurology INC
Columbia, Missouri, United States - (and 2 more...)
|
| 9 |
NCT01315938 |
Unknown † |
Abatacept Treatment in Polymyositis and Dermatomyositis |
- Polymyositis
- Dermatomyositis
|
|
Interventional |
Phase 2 |
- Karolinska Institutet
- Institute of Rheumatology, Prague, Czech Republic
- King's College Hospital NHS Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- The number of responders, defined as improved according the IMACS criteria
- The change in the individual components of the IMACS core set measures for disease activity
|
20 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01315938 |
2009-015957-20 |
ARTEMIS |
January 2011 |
December 2012 |
June 2013 |
March 16, 2011 |
March 16, 2011 |
|
- Institute of Rheumatology
Prague, Czech Republic - Karolinska University Hospital
Stockholm, Sweden
|
| 10 |
NCT00335985 |
Completed |
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM) |
- Polymyositis
- Dermatomyositis
|
- Drug: GB-0998
- Drug: Placebo of GB-0998
|
Interventional |
Phase 3 |
- Japan Blood Products Organization
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes in manual muscle strength (MMT) scores
- Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)
- Adverse events and laboratory tests
|
26 |
All |
16 Years to 75 Years (Child, Adult, Senior) |
NCT00335985 |
0998-12 |
|
June 2006 |
March 2009 |
March 2009 |
June 12, 2006 |
November 5, 2014 |
|
- Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan
|
| 11 |
NCT01415219 |
Completed |
Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis |
- Dermatomyositis
- Polymyositis
|
- Other: Active rehabilitation
|
Interventional |
Phase 2 |
- University Hospital, Lille
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- HAQ score
- Quality of life (SF36 score)
- MFM(motor function measure)
- muscle strength (MRC manual muscle testing)
|
80 |
All |
18 Years to 65 Years (Adult) |
NCT01415219 |
2007_0712
2007-A00756-47
PHRC 2006/1916
DGS 2007-0440 |
|
March 2008 |
March 2013 |
December 2013 |
August 11, 2011 |
December 18, 2014 |
|
- University Hospital, Lille
Lille, Nord Pas de Calais, France - Hopital Rotschild
Paris, France - GH Pitié Salpétrière
Paris, France - (and 2 more...)
|
| 12 |
NCT01148810 |
Terminated |
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis |
- Polymyositis
- Dermatomyositis
|
- Drug: BAF312
- Drug: Placebo
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Measure: Preliminary clinical efficacy using the IMACS core set measures
- Measure: Safety and tolerability using safety assessments
- Measure: Characterize the steady state pharmacokinetics
- (and 3 more...)
|
29 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01148810 |
CBAF312A2202
2008-006311-21 |
|
June 2010 |
June 2012 |
June 2012 |
June 22, 2010 |
August 1, 2013 |
|
- Novartis Investigative Site
Boston, Massachusetts, United States - Novartis Investigative Site
Prague 2, Czech Republic - Novartis Investigative Site
Budapest, Hungary - (and 3 more...)
|
| 13 |
NCT00001421 |
Completed |
Methimazole to Treat Polymyositis and Dermatomyositis |
- Dermatomyositis
- Polymyositis
|
|
Interventional |
Phase 2 |
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
20 |
All |
Child, Adult, Senior |
NCT00001421 |
950139
95-AR-0139 |
|
June 1995 |
|
April 2001 |
December 10, 2002 |
March 4, 2008 |
|
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, United States
|
| 14 |
NCT00033891 |
Completed |
Infliximab (Remicade ) to Treat Dermatomyositis and Polymyositis |
- Dermatomyositis
- Polymyositis
|
|
Interventional |
Phase 2 |
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
14 |
All |
18 Years and older (Adult, Senior) |
NCT00033891 |
020156
02-AR-0156 |
|
April 10, 2002 |
July 31, 2007 |
May 20, 2010 |
April 12, 2002 |
April 4, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 15 |
NCT00651040 |
Completed
Has Results |
Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM |
- Polymyositis
- Dermatomyositis
|
- Drug: Prednisone
- Drug: Methotrexate
|
Interventional |
Phase 3 |
- Institute of Rheumatology, Prague
- Karolinska Institutet
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.
- Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures
|
31 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00651040 |
3401 |
Prometheus |
May 2008 |
November 2014 |
November 2014 |
April 2, 2008 |
May 12, 2016 |
May 12, 2016 |
- Revmatologicky ustav
Prague, Czech Republic
|
| 16 |
NCT00866125 |
Completed |
Hand Function in Patients With Poly- or Dermatomyositis |
- Polymyositis
- Dermatomyositis
|
|
Observational |
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
|
31 |
All |
18 Years and older (Adult, Senior) |
NCT00866125 |
02-078 |
|
April 2002 |
|
August 2002 |
March 20, 2009 |
March 20, 2009 |
|
|
| 17 |
NCT02881450 |
Completed |
Epidemiological Study of Inflammatory Myopathies in a French Region |
|
|
Observational |
|
- University Hospital, Strasbourg, France
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Estimate the prevalence of idiopathic inflammatory myopathies in Alsace.
|
117 |
All |
Child, Adult, Senior |
NCT02881450 |
4963 |
PREMIA |
January 2012 |
December 2013 |
|
August 29, 2016 |
August 29, 2016 |
|
|
| 18 |
NCT02159651 |
Active, not recruiting |
A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia |
- Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Overall survival
- Respiratory function test value (%FVC, %DLco)
- Arterial blood gas analysis value (PaO2, AaDO2)
- (and 4 more...)
|
179 |
All |
Child, Adult, Senior |
NCT02159651 |
PRGI01
506-MA-PRGI-01 |
|
April 1, 2014 |
January 2020 |
January 2020 |
June 10, 2014 |
March 19, 2018 |
|
- Chubu, Japan
- Chugoku, Japan
- Hokkaido, Japan
- (and 5 more...)
|
| 19 |
NCT02780674 |
Completed |
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases |
- Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
|
- Biological: MEDI7734
- Biological: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Event
- Anti-drug antibodies
- Pharmacokinetics
- (and 2 more...)
|
36 |
All |
18 Years to 65 Years (Adult) |
NCT02780674 |
D6080C00001 |
|
August 26, 2016 |
October 23, 2017 |
November 27, 2017 |
May 23, 2016 |
February 5, 2018 |
|
- Research Site
Anniston, Alabama, United States - Research Site
Birmingham, Alabama, United States - Research Site
Danbury, Connecticut, United States - (and 4 more...)
|
| 20 |
NCT03092154 |
Recruiting |
Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis |
|
- Drug: Lipid-lowering agents (Artovastatin)
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Endothelial function
- Side effects
- Patient/Parent Global Activity
- (and 5 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT03092154 |
MYO-HCFMUSP-03 |
|
January 2017 |
January 2020 |
January 2020 |
March 27, 2017 |
March 27, 2017 |
|
- Samuel Katsuyuki Shinjo
Sao Paulo, Brazil
|
| 21 |
NCT00504348 |
Completed |
Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus |
- Interstitial Pneumonitis
- Polymyositis
- Dermatomyositis
|
|
Interventional |
Phase 2
Phase 3 |
- Tokyo Medical and Dental University
- Japan Medical Association
- Astellas Pharma Inc
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Progression
|
26 |
All |
16 Years to 74 Years (Child, Adult, Senior) |
NCT00504348 |
IICT-FK506-01 |
IMPPACT |
July 2007 |
January 2011 |
January 2011 |
July 20, 2007 |
November 17, 2017 |
|
- Hokkaido University Hospital
Sapporo, Hokkaido, Japan - Tsukuba University Hospital
Tsukuba, Ibaraki, Japan - Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan - (and 8 more...)
|
| 22 |
NCT00213629 |
Completed |
myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies |
- Polymyositis
- Dermatomyositis
|
- Other: transcriptome analysis
- Other: T cell repertoire analysis
|
Interventional |
Not Applicable |
- University Hospital, Rouen
- Association Française contre les Myopathies (AFM), Paris
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
|
100 |
All |
18 Years to 76 Years (Adult, Senior) |
NCT00213629 |
2003/094/HP |
MYOARRAY |
November 2004 |
July 2010 |
July 2010 |
September 21, 2005 |
February 16, 2012 |
|
- University Hospital of Rouen
Rouen, Seine Maritime, France
|
| 23 |
NCT00106184 |
Completed
Has Results |
Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) |
- Myositis
- Dermatomyositis
- Polymyositis
- Juvenile Dermatomyositis
|
- Drug: Rituximab
- Drug: Placebo
|
Interventional |
Phase 2 |
- University of Pittsburgh
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Genentech, Inc.
- Biogen
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients
- Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8
- 20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI])
|
200 |
All |
5 Years and older (Child, Adult, Senior) |
NCT00106184 |
N01 AR042273
5R01AR061298-02
HHSN26420042273C |
|
March 2006 |
February 2010 |
August 2010 |
March 22, 2005 |
March 4, 2015 |
March 4, 2015 |
- University of Alabama Arthritis Intervention Program (Adult Site)
Birmingham, Alabama, United States - Phoenix Neurological Associates, LTD (Adult Site)
Phoenix, Arizona, United States - Cedars-Sinai Medical Center (Adult Site)
Los Angeles, California, United States - (and 28 more...)
|
| 24 |
NCT01171573 |
Recruiting |
Investigating Genes in Patients With Polymyositis and Dermatomyositis |
|
|
Observational |
|
- Salford Royal NHS Foundation Trust
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- To identify any disease susceptibility genes associated with development and clinical characteristics of primary inflammatory muscle diseases, PM, DM and IBM.
|
1000 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01171573 |
Ollier-002 |
AOMIC |
January 2001 |
January 2019 |
January 2020 |
July 28, 2010 |
October 17, 2016 |
|
- Salford Royal NHS Foundation Trust
Manchester, United Kingdom
|
| 25 |
NCT03414086 |
Enrolling by invitation |
Predictor of Clinical Response to Acthar in Myositis |
- Myositis
- Dermatomyositis
- Polymyositis
|
- Other: Healthy Control
- Other: Myositis in Remission
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- IMACS Core Set Measures Improvement
- Myositis Response Criteria
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03414086 |
PRO16100125 |
|
November 6, 2017 |
May 6, 2018 |
May 7, 2018 |
January 29, 2018 |
January 29, 2018 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
| 26 |
NCT00001265 |
Recruiting |
Study and Treatment of Inflammatory Muscle Diseases |
- Autoimmune Disease
- Dermatomyositis
- Inclusion Body Myositis
- (and 2 more...)
|
|
Observational |
|
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
99999999 |
All |
16 Years and older (Child, Adult, Senior) |
NCT00001265 |
910196
91-AR-0196 |
|
August 8, 1991 |
|
|
November 4, 1999 |
April 13, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 27 |
NCT00001261 |
Completed |
Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies |
- Dermatomyositis
- Inclusion Body Myositis
- Polymyositis
|
|
Interventional |
Phase 2 |
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
120 |
All |
Child, Adult, Senior |
NCT00001261 |
900139
90-N-0139 |
|
May 1990 |
|
July 2002 |
November 4, 1999 |
March 4, 2008 |
|
- National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States
|
| 28 |
NCT01165008 |
Completed |
Anakinra in Myositis |
- Polymyositis
- Dermatomyositis
- Inclusion Body Myositis
|
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
|
|
|
All |
18 Years to 80 Years (Adult, Senior) |
NCT01165008 |
KS 01
03-144 |
|
September 2003 |
|
September 2008 |
July 19, 2010 |
July 19, 2010 |
|
- Karolinska University Hospital
Stockholm, Sweden
|
| 29 |
NCT00017914 |
Recruiting |
Adult and Juvenile Myositis |
- Dermatomyositis
- Polymyositis
- Inclusion Body Myositis
|
|
Observational |
|
- National Institute of Environmental Health Sciences (NIEHS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Physician global assessment form
|
1200 |
All |
Child, Adult, Senior |
NCT00017914 |
940165
94-E-0165 |
|
June 8, 1994 |
|
|
June 20, 2001 |
April 13, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 30 |
NCT01734369 |
Recruiting |
Environmental Risk Factors for Myositis in Military Personnel |
- Dermatomyositis
- Adult Polymyositis
- Inclusion Body Myositis
- Myositis
|
|
Observational |
|
- National Institute of Environmental Health Sciences (NIEHS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Control
- Time Perspective: Other
|
- Military Myositis Questionnaire
|
300 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT01734369 |
130015
13-E-0015 |
|
November 22, 2012 |
September 30, 2018 |
September 30, 2019 |
November 27, 2012 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 31 |
NCT01432613 |
Completed |
Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies |
- Myositis
- Polymyositis
- Dermatomyositis
- Myositis, Inclusion Body
|
- Procedure: MRI-oriented muscle biopsy
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI.
- Presence of IIM diagnosed by muscle biopsy
- Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation
- Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation
|
139 |
All |
18 Years and older (Adult, Senior) |
NCT01432613 |
K071204 |
DARWIM |
December 22, 2010 |
February 11, 2016 |
November 26, 2016 |
September 13, 2011 |
March 2, 2018 |
|
- CHU Amiens Nord
Amiens, France
|
| 32 |
NCT02971683 |
Recruiting |
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
- (and 2 more...)
|
- Drug: Abatacept subcutaneous
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of subjects who achieve International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24
- Mean change from baseline to Week 12 in muscle endurance test using the Myositis Function Index (FI-2)
- Mean change from baseline to Week 24 in muscle endurance test using the Myositis Function Index (FI-2)
- (and 6 more...)
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT02971683 |
IM101-611
2016-002269-77 |
|
March 13, 2017 |
June 17, 2020 |
June 4, 2021 |
November 23, 2016 |
March 7, 2018 |
|
- Local Institution
Phoenix, Arizona, United States - Neuromuscular Research Center
Phoenix, Arizona, United States - Attune Health
Beverly Hills, California, United States - (and 88 more...)
|
| 33 |
NCT00001167 |
Completed |
Ultrasound Evaluation of Tongue Movements in Speech and Swallowing |
- Otorhinolaryngologic Disease
- Otorhinolaryngologic Neoplasm
- Pharyngeal Neoplasm
- (and 2 more...)
|
|
Observational |
|
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
570 |
All |
Child, Adult, Senior |
NCT00001167 |
790101
79-CC-0101 |
|
August 1979 |
|
November 2004 |
November 4, 1999 |
March 4, 2008 |
|
- Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States
|
| 34 |
NCT00138983 |
Completed |
Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. |
- Rheumatoid Arthritis
- Polymyalgia Rheumatica
- Giant Cell Arteritis
- (and 2 more...)
|
- Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)
|
Interventional |
Phase 3 |
- UMC Utrecht
- Dutch Health Care Insurance Board
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.
- Percent change in bone mineral density of the femoral neck and total hip at 18 months and incidence of morphometrical vertebral deformities, symptomatic vertebral fractures and non-vertebral fractures.
|
200 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT00138983 |
OG67-STOP-study |
|
May 2000 |
|
November 2003 |
August 30, 2005 |
November 29, 2006 |
|
- UMC Utrecht
Utrecht, Netherlands
|
| 35 |
NCT00001331 |
Completed |
Genetic and Family Studies of Inherited Muscle Diseases |
- Dermatomyositis
- Glycogen Storage Disease Type II
- Glycogen Storage Disease Type VII
- (and 2 more...)
|
|
Observational |
|
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
|
All |
Child, Adult, Senior |
NCT00001331 |
930143
93-AR-0143 |
|
May 1993 |
|
March 2002 |
November 4, 1999 |
March 5, 2008 |
|
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, United States
|
| 36 |
NCT00971828 |
Unknown † |
A Case-control Study to Assess Risk of Coronary Heart Disease in Idiopathic Inflammatory Myopathy |
- Idiopathic Inflammatory Myopathy
|
|
Observational |
|
- Salford Royal NHS Foundation Trust
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT00971828 |
Chinoy-001 |
|
July 2011 |
September 2012 |
September 2012 |
September 4, 2009 |
August 15, 2011 |
|
- Welcome Trust Clinical Research Facility
Manchester, United Kingdom
|
| 37 |
NCT01482494 |
Unknown † |
Detection of Pompe Disease in Adult Patients With Myopathies of Uncertain Origin or With Asymptomatic Hyper-CK-emia |
|
|
Observational |
|
- Jordi Perez Lopez
- Hospital Vall d'Hebron
|
Other |
|
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01482494 |
GZ-2011-10784 |
|
December 2011 |
December 2012 |
|
November 30, 2011 |
December 1, 2011 |
|
- Hospital Clínico de Barcelona
Barcelona, Spain
|
| 38 |
NCT00443222 |
Completed |
Treatment With TNF Blockade, Infliximab, in Patients With Myositis |
|
|
Interventional |
Phase 2
Phase 3 |
- Karolinska Institutet
- Schering-Plough
- Medical Research Council
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
|
All |
18 Years and older (Adult, Senior) |
NCT00443222 |
Remicade myositis |
|
|
|
|
March 5, 2007 |
March 5, 2007 |
|
|
| 39 |
NCT03433638 |
Recruiting |
Juvenile Dermatomyositis |
|
|
Observational |
|
- University Hospital, Strasbourg, France
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Study of clinical characteristics of juvenile dermatomyositis
|
22 |
All |
up to 16 Years (Child) |
NCT03433638 |
6785 |
|
February 8, 2018 |
January 2019 |
January 2019 |
February 14, 2018 |
February 27, 2018 |
|
- Service de Dermatologie
Strasbourg, France
|
| 40 |
NCT03432455 |
Recruiting |
Incidence and Prevalence of Juvenile Dermatomyositis |
|
|
Observational |
|
- University Hospital, Strasbourg, France
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Identify incident and prevalent cases of juvenile dermatomyositis according to Bohan and Peter's criteria at january 1st, 2016 via capture/recapture strategy
|
22 |
All |
up to 16 Years (Child) |
NCT03432455 |
6784 |
|
February 7, 2018 |
January 2019 |
January 2019 |
February 14, 2018 |
February 14, 2018 |
|
- Service de Dermatologie
Strasbourg, France
|
| 41 |
NCT03293615 |
Not yet recruiting |
Exercise Capacity of Patients With Dermatomyosis |
|
|
Interventional |
Not Applicable |
- University Hospital, Strasbourg, France
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.
|
45 |
All |
18 Years and older (Adult, Senior) |
NCT03293615 |
6431 |
MIDE |
July 1, 2018 |
July 1, 2018 |
January 1, 2025 |
September 26, 2017 |
March 27, 2018 |
|
|
| 42 |
NCT03181893 |
Recruiting |
A Study In Adults With Moderate To Severe Dermatomyositis |
|
- Drug: PF-06823859
- Drug: Placebo Arm
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- CDASI Activity Score
- CDASI Activity Scores
- CDASI Damage score
|
30 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03181893 |
C0251002 |
|
January 23, 2018 |
October 27, 2019 |
March 25, 2020 |
June 9, 2017 |
March 29, 2018 |
|
- Mayo Clinic
Scottsdale, Arizona, United States - Freidenrich Center for Translational Research at Stanford University
Palo Alto, California, United States - Stanford Investigational Pharmacy
Stanford, California, United States - (and 12 more...)
|
| 43 |
NCT03002649 |
Recruiting |
Study of Tofacitinib in Refractory Dermatomyositis |
|
|
Interventional |
Phase 1 |
- Johns Hopkins University
- Pfizer
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants who achieve International Myositis Assessment and Clinical Studies (IMACS) Definition of Improvement (DOI)
- Change from baseline in CDASI activity score
- Safety and tolerability of tofacitinib as assessed by frequency of adverse events reported and observed
- Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT03002649 |
IRB00084227 |
STIR |
January 2017 |
October 2018 |
June 2019 |
December 26, 2016 |
February 19, 2018 |
|
- Johns Hopkins University
Baltimore, Maryland, United States
|
| 44 |
NCT02980198 |
Recruiting |
Study of IFN-K in Dermatomyositis |
|
- Biological: IFN-Kinoid
- Other: Placebo
- Other: ISA 51
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change from baseline in the expression of IFN-induced genes at Week 48
- Number of subjects with treatment related adverse events
- Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations
- (and 5 more...)
|
30 |
All |
18 Years to 65 Years (Adult) |
NCT02980198 |
IFN-K-005-DM
2016-000137-52 |
|
November 2016 |
December 2018 |
|
December 2, 2016 |
September 11, 2017 |
|
- Research site
Lille, France - Research site
Marseille, France - Research site
Paris, France - (and 5 more...)
|
| 45 |
NCT02945345 |
Recruiting |
Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) |
|
|
Observational |
|
- University of Pennsylvania
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Cutaneous Dermatomyositis Disease Area and Severity Index
- Skin quality of life tool
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT02945345 |
808230 |
CDASI |
June 2008 |
June 2020 |
June 2020 |
October 26, 2016 |
October 26, 2016 |
|
- Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 46 |
NCT02728752 |
Recruiting |
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy) |
|
- Drug: Octagam 10%
- Other: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Measure the number of patients who had an increase of ≥20 points on the Total Improvement Score (TIS)
- Mean change from baseline (Week 0) to end of first period (Week 16) in: Total Improvement Score (TIS)
- Mean change from baseline (Week 0) to Week 40 in: Total Improvement Score (TIS)
- (and 6 more...)
|
94 |
All |
18 Years and older (Adult, Senior) |
NCT02728752 |
GAM10-08 |
IIM |
February 27, 2017 |
March 2019 |
March 2019 |
April 5, 2016 |
March 5, 2018 |
|
- Octapharma Research Site
Birmingham, Alabama, United States - Octapharma Research Site
Phoenix, Arizona, United States - Octapharma Research Site
Los Angeles, California, United States - (and 37 more...)
|
| 47 |
NCT02612857 |
Active, not recruiting |
Trial of IMO-8400 in Adult Patients With Dermatomyositis |
|
- Drug: IMO-8400 Dose Group 1
- Drug: IMO-8400 Dose Group 2
- Drug: Placebo
|
Interventional |
Phase 2 |
- Idera Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Incidence and frequency of adverse events, injection site reaction, physical exam and laboratory exam findings with escalating dose levels of IMO-8400
- Change from baseline in CDASI Activity score
|
36 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02612857 |
8400-211 |
8400-211 |
November 2015 |
May 16, 2018 |
September 2018 |
November 24, 2015 |
October 11, 2017 |
|
- University of Alabama
Birmingham, Alabama, United States - Phoenix Neurological Associates
Phoenix, Arizona, United States - University of California, Irvine
Irvine, California, United States - (and 17 more...)
|
| 48 |
NCT02594735 |
Recruiting |
Abatacept in Juvenile Dermatomyositis |
|
|
Interventional |
Phase 4 |
- George Washington University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients meeting the definition of improvement (DOI) at week 24: at least 3 of 6 Core Set Measures (CSM) improved by ≥ 20% with no more than 2 CSM worsening by ≥ 25% (not including the manual muscle testing).
- Incidence of treatment-emergent adverse events.
- Number of patients improving in Physician and Patient/Parent global activity measurement from baseline
- (and 9 more...)
|
10 |
All |
7 Years and older (Child, Adult, Senior) |
NCT02594735 |
IRB 111418 |
AID |
November 2015 |
December 2018 |
December 2018 |
November 3, 2015 |
March 20, 2018 |
|
- 2300 M Street, 9th floor. Medical Faculty Associates, The George Washington University.
Washington, District of Columbia, United States
|
| 49 |
NCT02466243 |
Active, not recruiting |
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis |
|
- Drug: JBT-101
- Drug: Placebo
|
Interventional |
Phase 2 |
- Corbus Pharmaceuticals Inc.
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- University of Pennsylvania
|
Industry / NIH / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of participants with treatment emergent adverse events as a measure of safety and tolerability
- Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) from baseline in Part A.
- Change in patient-reported outcomes from baseline at 84 days for Part A
- Change in patient-reported outcomes from baseline at 364 days for Part B
|
22 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02466243 |
JBT101-DM-001
116313
R21AR066286 |
|
June 2015 |
August 2017 |
September 2019 |
June 9, 2015 |
March 16, 2018 |
|
- University of Pennsylvania Perlman School of Medicine
Philadelphia, Pennsylvania, United States
|
| 50 |
NCT02271165 |
Recruiting |
Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study |
|
- Drug: Immunoglobulin (Hizentra)
|
Interventional |
Early Phase 1 |
- Thomas Jefferson University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary outcome is a change in strength (based on MRC sumscores) from baseline (enrollment) to the mean change at weeks 16, 20, 24 and 28.
- The main secondary outcome is the preference of the participant for SCIg compared with IVIg
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT02271165 |
13P.192 |
|
November 2014 |
October 2018 |
|
October 22, 2014 |
November 10, 2016 |
|
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
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