| 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, Older Adult) |
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, Older Adult) |
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, Older Adult) |
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 13 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, Older Adult |
NCT02468895 |
UoMMYO |
MYOPROSP |
October 4, 2016 |
January 2021 |
January 2021 |
June 11, 2015 |
May 9, 2018 |
|
- 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, Older Adult) |
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, Older Adult) |
NCT03092180 |
MYO-HCFMUSP-01 |
|
January 2005 |
January 2019 |
January 2026 |
March 27, 2017 |
May 10, 2018 |
|
- 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, Older Adult) |
NCT01734369 |
130015
13-E-0015 |
|
November 22, 2012 |
September 30, 2018 |
September 30, 2019 |
November 27, 2012 |
June 13, 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, Older Adult) |
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, Older Adult) |
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, Older Adult) |
NCT03092167 |
MYO-HCFMUSP-02 |
|
January 2017 |
January 2022 |
January 2022 |
March 27, 2017 |
May 10, 2018 |
|
- Samuel Katsuyuki Shinjo
Sao Paulo, Brazil
|
|
| 11 |
NCT03440034 |
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 Peroxisome proliferator-activated receptor gamma coactivator 1-alpha target gene expression
|
15 |
All |
50 Years and older (Adult, Older Adult) |
NCT03440034 |
IRB00130996 |
|
May 22, 2018 |
June 1, 2020 |
December 31, 2020 |
February 20, 2018 |
May 28, 2018 |
|
- Johns Hopkins University
Baltimore, Maryland, United States
|
|
| 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, Older Adult |
NCT00017914 |
940165
94-E-0165 |
|
June 8, 1994 |
|
|
June 20, 2001 |
May 18, 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, Older Adult) |
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, Older Adult) |
NCT00001265 |
910196
91-AR-0196 |
|
August 8, 1991 |
|
|
November 4, 1999 |
May 21, 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, Older Adult) |
NCT03267277 |
170161
17-E-0161 |
|
October 5, 2017 |
May 12, 2021 |
June 18, 2025 |
August 30, 2017 |
June 13, 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, Older Adult) |
NCT03312634 |
PVO-1A-301 |
|
November 28, 2017 |
September 2020 |
November 2020 |
October 18, 2017 |
June 20, 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 8 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, Older Adult) |
NCT02728752 |
GAM10-08 |
IIM |
February 27, 2017 |
March 2019 |
March 2019 |
April 5, 2016 |
April 23, 2018 |
|
- Octapharma Research Site
Birmingham, Alabama, United States - Octapharma Research Site
Phoenix, Arizona, United States - Octapharma Research Site
Los Angeles, California, United States - (and 42 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 |
March 1, 2018 |
September 3, 2019 |
August 4, 2020 |
June 15, 2017 |
June 14, 2018 |
|
- Mayo Clinica
Rochester, Minnesota, United States - Hospital Universitario San Ignacio
Bogotá, Cundinamarca, Colombia - Giannina Gaslini Institute
Genova, Italy - (and 2 more...)
|
|
| 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, Older Adult |
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, Older Adult) |
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, Older Adult) |
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, Older Adult |
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 |
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, Older Adult) |
NCT03492242 |
CIC1421-18-06 |
CHIMeRA |
February 1, 2018 |
June 30, 2018 |
June 30, 2018 |
April 10, 2018 |
May 8, 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, Older Adult) |
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, Older Adult |
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, Older Adult) |
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 |
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
|
- VO2 max, L/min and ml/kgxmin
- Aerobic capacity, Watt max
- Myositis Disease Activity Assessment Tool (MDAAT) - physician's global assessment.
- (and 23 more...)
|
30 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03324152 |
KarolinskaUH1 |
HIITmyositis |
October 1, 2017 |
December 31, 2020 |
December 31, 2021 |
October 27, 2017 |
April 23, 2018 |
|
- Karolinska University Hospital
Stockholm, N/A = Not Applicable, Sweden
|
|
| 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, Older Adult) |
NCT03092154 |
MYO-HCFMUSP-03 |
|
January 2017 |
January 2020 |
January 2020 |
March 27, 2017 |
May 10, 2018 |
|
- 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, Older Adult) |
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 |
NCT03529955 |
Recruiting |
Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis |
- Dermatomyositis, Adult Type
|
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary endpoint analysis would be overall response rate measured by the number of participants experiencing at least 4 points decrease in CDASI activity score at 3 months.
- 2. The secondary endpoint analysis would be safety as measured by the number of participants experiencing adverse events and serious adverse events occurring during 6 months of therapy and 1 month follow up.
- 3. An additional secondary endpoint analysis would be durability of response measured by the number of participants with maintenance of their CDASI activity score or change in their CDASI activity score by at least 4 points compared to 3 months.
- (and 2 more...)
|
10 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03529955 |
2017-978 |
|
June 2018 |
December 2018 |
June 2019 |
May 21, 2018 |
June 14, 2018 |
|
- Tulane University
New Orleans, Louisiana, United States
|
|
| 35 |
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, Older Adult) |
NCT03293615 |
6431 |
MIDE |
July 1, 2018 |
July 1, 2018 |
January 1, 2025 |
September 26, 2017 |
March 27, 2018 |
|
|
|
| 36 |
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, Older Adult) |
NCT03181893 |
C0251002 |
|
January 23, 2018 |
October 27, 2019 |
March 25, 2020 |
June 9, 2017 |
June 8, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - UAB Hospital, IDS Pharmacy
Birmingham, Alabama, United States - Mayo Clinic
Scottsdale, Arizona, United States - (and 19 more...)
|
|
| 37 |
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, Older Adult) |
NCT03002649 |
IRB00084227 |
STIR |
January 2017 |
October 2018 |
June 2019 |
December 26, 2016 |
February 19, 2018 |
|
- Johns Hopkins University
Baltimore, Maryland, United States
|
|
| 38 |
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, Older 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...)
|
|
| 39 |
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, Older Adult) |
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
|
|
| 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, Older Adult) |
NCT02245841 |
14-1015 |
Acthar Gel |
June 2015 |
May 2019 |
October 2019 |
September 22, 2014 |
January 25, 2018 |
|
- Cleveland Clinic
Cleveland, Ohio, United States
|
|
| 41 |
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, Older Adult) |
NCT03192657 |
ADM01 |
|
July 2017 |
June 2019 |
June 2020 |
June 20, 2017 |
June 20, 2017 |
|
- RenJi Hospital
Shanghai, Shanghai, China
|
|
| 42 |
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
|
|
| 43 |
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, Older Adult) |
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
|
|
| 44 |
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, Older Adult) |
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
|
|
| 45 |
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, Older Adult) |
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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