| 1 |
NCT02347891 |
Recruiting |
Belimumab in Myositis |
|
- Drug: Belimumab
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Northwell Health
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Response Rate
- Incidence of Flares
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02347891 |
14-621 |
BIM |
January 2015 |
December 2019 |
December 2019 |
January 28, 2015 |
August 22, 2017 |
|
- Phoenix Neurlogical Associates
Phoenix, Arizona, United States - Northwell Health Divison of Rheumatology
Great Neck, New York, United States
|
| 2 |
NCT03299335 |
Recruiting |
Molecular Profile of the Evolution of Inclusion Body Myositis |
|
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire de Nice
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- sIBM gene expression profile
- CPK level
- Rate of cN-1A antibodies.
- IWCI score
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT03299335 |
16-AOI-05 |
IBM-RNAseq |
February 1, 2018 |
February 1, 2019 |
February 1, 2019 |
October 3, 2017 |
January 16, 2018 |
|
- Hôpital Pasteur 2 - Service Système Nerveux Périphérique, Muscle et SLA
Nice, France
|
| 3 |
NCT02753530 |
Recruiting |
Study of Arimoclomol in Inclusion Body Myositis (IBM) |
|
- Drug: Arimoclomol
- Other: Placebo
|
Interventional |
Phase 2 |
- Orphazyme
- University of Kansas Medical Center
- University College, London
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Decline in Inclusion body myositis functional rating scale (IBMFRS)
- Manual Muscle Testing (MMT)
- Maximum voluntary isometric contraction (MVICT) of quadriceps
- (and 6 more...)
|
150 |
All |
45 Years and older (Adult, Senior) |
NCT02753530 |
STUDY00002461
R01FD004809-01A2 |
|
August 9, 2017 |
December 2021 |
December 2021 |
April 28, 2016 |
February 13, 2018 |
|
- University of Kansas Medical Center
Kansas City, Kansas, United States - University of College of London
London, United Kingdom
|
| 4 |
NCT02468895 |
Recruiting |
MYOPROSP - a Prospective Cohort Study in Myositis |
- Myositis
- Idiopathic Inflammatory Myopathy
|
|
Observational |
|
- University of Manchester
- University of Bath
- University College, London
- (and 6 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of participants with a significant change levels of diagnostic biomarkers.
- Number of participants with a 20% improvement in myositis specific disease activity measures from baseline
- Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls
|
300 |
All |
Child, Adult, Senior |
NCT02468895 |
UoMMYO |
MYOPROSP |
October 4, 2016 |
February 2021 |
February 2021 |
June 11, 2015 |
February 1, 2017 |
|
- The University of Manchester
Manchester, Please Select, United Kingdom
|
| 5 |
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
|
| 6 |
NCT03092180 |
Recruiting |
Optimizing Treatment on Idiopathic Inflammatory Myopathies |
- Idiopathic Inflammatory Myopathies
|
- Drug: Intravenous Infusion
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Physician Global Activity
- Patient/Parent Global Activity -
- Manual Muscle Testing
- (and 4 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT03092180 |
MYO-HCFMUSP-01 |
|
January 2005 |
January 2018 |
January 2026 |
March 27, 2017 |
March 28, 2017 |
|
- Samuel Katsuyuki Shinjo
Sao Paulo, Brazil
|
| 7 |
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
|
| 8 |
NCT01276470 |
Recruiting |
Environmental Risk Factors for the Anti-synthetase Syndrome |
|
|
Observational |
|
- National Institute of Environmental Health Sciences (NIEHS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Other
|
- To determine whether selected noninfectious environmental exposures are more common prior to disease in recent-onset pts. w/anti-sythetase syndrome compared w/controls w/o autoimmune disease (1:1 matched with the pts.) and compared w/recent-onse...
|
450 |
All |
2 Years to 120 Years (Child, Adult, Senior) |
NCT01276470 |
110072
11-E-0072 |
|
January 12, 2011 |
|
|
January 13, 2011 |
February 14, 2018 |
|
- University of Miami
Miami, Florida, United States - Johns Hopkins University
Baltimore, Maryland, United States - Mid-Atlantic Kaiser Permanente-
Rockville, Maryland, United States - (and 4 more...)
|
| 9 |
NCT03215927 |
Recruiting |
Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease |
- Myositis
- Interstitial Lung Disease
|
- Drug: Abatacept
- Other: Placebo
|
Interventional |
Phase 2 |
- Rohit Aggarwal, MD
- Bristol-Myers Squibb
- University of Pittsburgh
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- FVC% Change
- Time to progression free survival where progression
- Comparison of change in patient reported dyspnea scores
- Time to improvement in FVC% by ≥10
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03215927 |
BMS: IM101-657 |
ATtackMy-ILD |
October 9, 2017 |
April 1, 2019 |
October 1, 2019 |
July 12, 2017 |
October 10, 2017 |
|
- Cedars-Sinai Medical Center
Beverly Hills, California, United States - University of Colorado Anschutz Medical Campus
Denver, Colorado, United States - John Hopkins Medical Center
Baltimore, Maryland, United States - (and 2 more...)
|
| 10 |
NCT03092167 |
Recruiting |
Physical Training in Patients With Idiopathic Inflammatory Myopathies |
- Idiopathic Inflammatory Myopathies
- Physical Activity
|
- Other: Physical exercises
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Cardiopulmonary test
- Serum cytokines
- Strength muscle tests
- (and 8 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT03092167 |
MYO-HCFMUSP-02 |
|
January 2017 |
January 2022 |
January 2022 |
March 27, 2017 |
March 28, 2017 |
|
- Samuel Katsuyuki Shinjo
Sao Paulo, Brazil
|
| 11 |
NCT03440034 |
Not yet recruiting |
Study of Pioglitazone in Sporadic Inclusion Body Myositis |
- Myositis
- Inclusion Body Myositis
- Muscular Diseases
- (and 3 more...)
|
|
Interventional |
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Change from baseline in PGC-1α target gene expression
|
15 |
All |
50 Years and older (Adult, Senior) |
NCT03440034 |
IRB00130996 |
|
March 15, 2018 |
June 1, 2020 |
December 31, 2020 |
February 20, 2018 |
February 20, 2018 |
|
|
| 12 |
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 20, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 13 |
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...)
|
| 14 |
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 20, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 15 |
NCT03267277 |
Recruiting |
Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis |
- Dermatomyositis
- Idiopathic Inflammatory Myopathies
|
|
Interventional |
Phase 2 |
- National Institute of Environmental Health Sciences (NIEHS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in calcinosis severity visual analogue scale score from week 0 to week 10 on therapy, compared to the baseline change in calcinosis severity visual analogue scale score from week -10 to week 0 pre treatment.
- Greater improvement in quality of life score (CHQ-PF50 for children, SF-36 for adults) from Week 0 to Week 10, compared with any change in quality of life score observed during the pre-treatment period (from Week -10 to Week 0).
- Changes in components of quality of life over time, as measured by quality of life questionnaires (e.g., SF-36, CHQ-PF50, PROMIS, Skindex-29)
- (and 7 more...)
|
250 |
All |
7 Years to 99 Years (Child, Adult, Senior) |
NCT03267277 |
170161
17-E-0161 |
|
October 5, 2017 |
May 12, 2021 |
June 18, 2025 |
August 30, 2017 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 16 |
NCT03312634 |
Recruiting |
An Efficacy and Safety Study of Palovarotene for the Treatment of FOP |
- Fibrodysplasia Ossificans Progressiva
|
|
Interventional |
Phase 3 |
- Clementia Pharmaceuticals Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in New HO Volume
- Subjects with New HO
- Number of Body Regions with HO
- (and 4 more...)
|
80 |
All |
4 Years and older (Child, Adult, Senior) |
NCT03312634 |
PVO-1A-301 |
|
November 28, 2017 |
September 2020 |
November 2020 |
October 18, 2017 |
March 27, 2018 |
|
- University of California San Francisco, Division of Endocrinology and Metabolism
San Francisco, California, United States - Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States - University of Pennsylvania
Philadelphia, Pennsylvania, United States - (and 5 more...)
|
| 17 |
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...)
|
| 18 |
NCT03188666 |
Recruiting |
A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva |
- Fibrodysplasia Ossificans Progressiva
|
- Drug: REGN2477
- Drug: Matching placebo
|
Interventional |
Phase 2 |
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence and severity of treatment-emergent adverse events (TEAEs) through the end of the Treatment Period 1 at week 28
- Time-weighted average (standardized area under the curve [AUC]) percent change from baseline in total lesion activity by 18F-NaF PET over 28 weeks
- Percent change from baseline in the total volume of HO lesions as assessed by CT at week 28
- (and 9 more...)
|
40 |
All |
18 Years to 60 Years (Adult) |
NCT03188666 |
R2477-FOP-1623
2016-005035-33 |
LUMINA-1 |
November 15, 2017 |
June 12, 2019 |
May 14, 2020 |
June 15, 2017 |
February 26, 2018 |
|
- Mayo Clinica
Rochester, Minnesota, United States - Giannina Gaslini Institute
Genova, Italy - Royal National Orthopaedic Hopsital, Brockley Hill
Stanmore, Middlesex, United Kingdom
|
| 19 |
NCT02745158 |
Recruiting |
The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry |
- Fibrodysplasia Ossificans Progressiva (FOP)
|
|
Observational |
|
- The International FOP Association
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Patient Reported Changes in New Bone Growth Using a Patient-Directed Survey Developed by the IFOPA
- Patient Reported Changes in Episodic Flare-Ups Using a Patient-Directed Survey Developed by the IFOPA
- Patient Reported Changes in Mobility Using a Patient-Directed Survey Developed by the IFOPA
- (and 9 more...)
|
800 |
All |
Child, Adult, Senior |
NCT02745158 |
IFOPA-REG-001 |
|
July 2015 |
July 2025 |
December 2025 |
April 20, 2016 |
August 17, 2017 |
|
- The International FOP Association
Casselberry, Florida, United States
|
| 20 |
NCT01862926 |
Recruiting |
Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD |
- Interstitial Lung Disease
- Scleroderma
- Idiopathic Inflammatory Myositis
- Mixed Connective Tissue Disease
|
- Drug: Rituximab
- Drug: Cyclophosphamide
|
Interventional |
Phase 2
Phase 3 |
- Royal Brompton & Harefield NHS Foundation Trust
- Imperial College London
- University of East Anglia
- University College London Hospitals
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Absolute change in FVC
- • Change from baseline in diffusing capacity for carbon monoxide (DLco)
- • Change from baseline in health related quality of life scores
- (and 3 more...)
|
116 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01862926 |
RBHIPF004
2012-003633-42 |
RECITAL |
November 2014 |
November 2019 |
November 2020 |
May 27, 2013 |
June 8, 2017 |
|
- Royal Brompton Hospital
London, United Kingdom
|
| 21 |
NCT03126383 |
Not yet recruiting |
Inflammatory Myopathies in Primary Sjögren's Syndrome |
|
|
Observational |
|
- University Hospital, Brest
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Proportion of patients fulfilling classification criteria for inflammatory myopathies
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03126383 |
AMISS (29BRC17.0031) |
AMISS |
May 10, 2017 |
April 10, 2018 |
April 10, 2018 |
April 24, 2017 |
April 24, 2017 |
|
- CHRU de Brest
Brest, France
|
| 22 |
NCT02979626 |
Recruiting |
Evaluation of Moderate to Severe Influenza Outcomes in Children |
- Influenza
- Otitis Media
- Lower Resp Tract Infection
- (and 3 more...)
|
- Procedure: Respiratory nasal swab
|
Observational |
|
- University of Colorado, Denver
- GlaxoSmithKline
|
Other / Industry |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Hospitalization
- ICU admission
- Antiviral use
- (and 4 more...)
|
1600 |
All |
6 Months to 8 Years (Child) |
NCT02979626 |
16-1785 |
M2SFlu |
February 4, 2017 |
March 2018 |
April 2018 |
December 1, 2016 |
January 17, 2018 |
|
- Children's Hospital Colorado
Aurora, Colorado, United States - Children's Hospital North Campus Urgent Care
Broomfield, Colorado, United States
|
| 23 |
NCT00055055 |
Recruiting |
Study of Families With Twins or Siblings Discordant for Rheumatic Disorders |
- Rheumatic Diseases
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- (and 3 more...)
|
|
Observational |
|
- National Institute of Environmental Health Sciences (NIEHS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Physician Global Assesment Questionnaire
|
1550 |
All |
Child, Adult, Senior |
NCT00055055 |
030099
03-E-0099 |
|
February 14, 2003 |
|
|
February 17, 2003 |
April 4, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States - University of Wisconsin
Madison, Wisconsin, United States
|
| 24 |
NCT03492242 |
Recruiting
New |
Immune CHeckpoint Inhibitors Monitoring of Adverse Drug ReAction |
- Arthritis
- Cancer
- Cardiac Disease
- (and 5 more...)
|
- Drug: Immune checkpoint inhibitor
|
Observational |
|
- Groupe Hospitalier Pitie-Salpetriere
- Institut National de la Santé Et de la Recherche Médicale, France
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Adverse drug reactions induced by ICIs and reported in the World Health Organization (WHO) or the Base Nationale de Pharmacovigilance (BNPV)
- Causality assessment of reported adverse drug reaction according to the WHO system
- Description of the type of adverse drug reaction depending on the category of ICIs
- (and 5 more...)
|
1000 |
All |
18 Years and older (Adult, Senior) |
NCT03492242 |
CIC1421-18-06 |
CHIMeRA |
February 1, 2018 |
May 1, 2018 |
May 1, 2018 |
April 10, 2018 |
April 11, 2018 |
|
- AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, France
|
| 25 |
NCT02466217 |
Recruiting |
Phenomics in Autoimmune and Inflammatory Diseases |
- Healthy Volunteer
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- (and 10 more...)
|
- Other: 1: AID groups
- Other: 2: Control groups
|
Observational |
|
- Assistance Publique - Hôpitaux de Paris
- National Research Agency, France
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- Total peripheral blood gene expression between patients, expressed as fluorescence intensity
- Tregs and Tconvs T cell receptor repertoire, expressed as the % of unique TCR sequences
- HLA type and SNPs expressed as the occurrence events across patients
- (and 15 more...)
|
1300 |
All |
18 Years and older (Adult, Senior) |
NCT02466217 |
P141006
2015-A00558-41 |
TRANSIMMUNOM |
July 2015 |
July 2019 |
July 2021 |
June 9, 2015 |
December 13, 2016 |
|
- Rhumatologie - Hôpital Saint-Antoine
Paris, France - CIC Paris-Est, Hôpital PITIE SALPETRIERE
Paris, France
|
| 26 |
NCT02450396 |
Recruiting |
Pregnancy and Medically Assisted Conception in Rare Diseases |
- Rheumatoid Arthritis
- Spondyloarthritis
- Psoriatic Arthritis
- (and 8 more...)
|
|
Observational |
|
- Assistance Publique - Hôpitaux de Paris
- SNFMI
- SFR
- CRAT
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- "good" obstetric outcome
- Define the best therapeutic management strategies
- Conduct pharmacoepidemiologic studies
- Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).
|
1000 |
Female |
Child, Adult, Senior |
NCT02450396 |
13.381bis |
EGR2 |
June 2014 |
June 2019 |
December 2019 |
May 21, 2015 |
June 24, 2016 |
|
- Hôpital Cochin
Paris, France
|
| 27 |
NCT03430388 |
Recruiting |
Yellow Fever Vaccine in Patients With Rheumatic Diseases |
- Systemic Lupus
- Rheumatoid Arthritis
- Spondyloarthritis
- (and 8 more...)
|
- Biological: Yellow Fever vaccine (17D)
|
Interventional |
Not Applicable |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of participants with severe adverse events to the fractional dose of Yellow Fever vaccine
- Number of participants with protective levels of antibodies against Yellow Fever vaccine
- Association of number of patients with protective antibodies levels and disease activity in patients with chronic rheumatic diseases
- Number of participants with persistent protective levels of antibodies against Yellow Fever
|
600 |
All |
2 Years to 60 Years (Child, Adult) |
NCT03430388 |
VFAReumatoHC |
|
January 31, 2018 |
March 24, 2018 |
February 24, 2019 |
February 12, 2018 |
April 9, 2018 |
|
- Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Sao Paulo, Brazil
|
| 28 |
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
|
| 29 |
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
|
| 30 |
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
|
| 31 |
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 |
|
|
| 32 |
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
|
| 33 |
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...)
|
| 34 |
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 |
|
|
| 35 |
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...)
|
| 36 |
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
|
| 37 |
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...)
|
| 38 |
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
|
| 39 |
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
|
| 40 |
NCT02245841 |
Recruiting |
Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis |
- Dermatomyositis
- Juvenile Dermatomyositis
|
|
Interventional |
Phase 4 |
- The Cleveland Clinic
- Mallinckrodt
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline in cutaneous manifestations of dermatomyositis at 1, 3, and 6 months
- Change from baseline in patient assessment of dermatomyositis at 1, 3, and 6 months
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT02245841 |
14-1015 |
Acthar Gel |
June 2015 |
May 2019 |
October 2019 |
September 22, 2014 |
January 25, 2018 |
|
- Cleveland Clinic
Cleveland, Ohio, United States
|
| 41 |
NCT02821689 |
Not yet recruiting |
Pirfenidone in Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis |
- Dermatopolymyositis
- Interstitial Lung Disease
|
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- changes of 12-month survival from the onset of ILD
- changes of high-resolution computed tomography (HRCT) scores from baseline at each visit
- changes of pulmonary function test from baseline at each visit
|
57 |
All |
16 Years and older (Child, Adult, Senior) |
NCT02821689 |
RenJi-ADM |
|
July 2016 |
June 2017 |
June 2018 |
July 1, 2016 |
July 1, 2016 |
|
- Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University
Shanghai, Shanghai, China
|
| 42 |
NCT03192657 |
Not yet recruiting |
Basiliximab Treating Interstitial Pneumonia of CADM |
- Lung; Disease, Interstitial, With Fibrosis
- Dermatomyositis
|
- Drug: Basiliximab
- Drug: Calcineurin Inhibitors
- Drug: Steroids
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Survival
- Forced vital capacity
- Total lung capacity
- (and 4 more...)
|
100 |
All |
18 Years to 65 Years (Adult) |
NCT03192657 |
ADM01 |
|
July 2017 |
June 2019 |
June 2020 |
June 20, 2017 |
June 20, 2017 |
|
- RenJi Hospital
Shanghai, Shanghai, China
|
| 43 |
NCT02418273 |
Not yet recruiting |
Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders |
- Osteoporosis
- Juvenile Rheumatoid Arthritis
- Dermatomyositis
- (and 4 more...)
|
|
Interventional |
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in bone turnover marker (N-telopeptide (NTX) /creatinine ratio).
- The duration of suppression of the NTX/creatinine ratio
- The changes in bone specific alkaline phosphorus
- (and 14 more...)
|
24 |
All |
4 Years to 16 Years (Child) |
NCT02418273 |
1504269855 |
|
August 1, 2019 |
June 2021 |
June 2021 |
April 16, 2015 |
August 21, 2017 |
|
- Indiana University School of Medicine
Indianapolis, Indiana, United States
|
| 44 |
NCT01724580 |
Available |
Compassionate Use Protocol for the Treatment of Autoinflammatory Syndromes |
- Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature (CANDLE)
- Juvenile Dermatomyositis (JDM)
- Stimulator of Interferon Genes (STING)-Associated Vasculopathy With Onset During Infancy (SAVI)
- Aicardi-Goutières Syndrome (AGS)
|
|
Expanded Access |
|
|
Industry |
|
|
|
All |
6 Months and older (Child, Adult, Senior) |
NCT01724580 |
14559
I4V-MC-JAGA |
|
|
|
|
November 12, 2012 |
April 18, 2018 |
|
- (CANDLE and SAVI participants)Translational Autoinflammatory Disease Studies (TADS) National Institutes of Health
Bethesda, Maryland, United States - (JDM participants) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Pediatric Clinical Trials Unit (PCTU), National Institutes of Health
Bethesda, Maryland, United States - (AGS participants) Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
| 45 |
NCT02810028 |
Recruiting |
Acceptance and Commitment Therapy for Muscle Disease |
|
- Behavioral: Acceptance and Commitment Therapy (ACT)
|
Interventional |
Not Applicable |
- King's College Hospital NHS Trust
- King's College London
- Barts & The London NHS Trust
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Life areas
- Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains
- Work and Social Adjustment Scale (WSAS)
- (and 8 more...)
|
154 |
All |
18 Years and older (Adult, Senior) |
NCT02810028 |
PB-PG-061331085 |
ACTMuS |
July 2016 |
July 2018 |
July 2018 |
June 22, 2016 |
January 11, 2018 |
|
- King's College Hospital; The Royal London Hospital; University Hospital Southampton; King's College London
London, United Kingdom
|
| 46 |
NCT00031174 |
Recruiting |
Blood Component Collection From Patients With Rheumatic or Kidney Disease and Healthy Volunteers |
- Rheumatic Diseases
- Healthy Volunteers
|
|
Observational |
|
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- PBMC and Mononuclear cell study
|
10000 |
All |
18 Years and older (Adult, Senior) |
NCT00031174 |
020131
02-AR-0131 |
|
February 25, 2002 |
|
|
February 27, 2002 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
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