| 101 |
NCT02284984 |
Recruiting |
Synergetic B-cell Immodulation in SLE |
- Lupus Erythematosus, Systemic
|
- Drug: Rituximab with belimumab
|
Interventional
|
Phase 2 |
- Leiden University Medical Center
- Dutch Kidney Foundation
- ZonMw: The Netherlands Organisation for Health Research and Development
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction of pathogenic autoantibodies
- Seroconversion of pathogenic autoantibodies, in particular anti-dsDNA autoantibodies
- Safety and feasibility: number of patients with (serious) adverse events
- (and 3 more...)
|
15 |
All |
18 Years to 64 Years (Adult) |
NCT02284984 |
NL4813605814 |
SYNBIoSe |
March 2014 |
March 2018 |
March 2020 |
November 6, 2014 |
August 23, 2017 |
|
|
|
| 102 |
NCT02270970 |
Recruiting |
Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy |
- Systemic Lupus Erythematosus
|
|
Interventional
|
Phase 4 |
- Oklahoma Medical Research Foundation
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- BLAST-50 response rate in clinical responders vs non responders
- Time to flare compared to historical (untreated) controls from the BOLD study
- SRI-4 response rates compared to historical controls from the BOLD study
- (and 6 more...)
|
20 |
All |
16 Years to 70 Years (Child, Adult, Older Adult) |
NCT02270970 |
OMRF 14-18 |
BLAST |
October 2014 |
December 2018 |
December 2019 |
October 22, 2014 |
December 7, 2017 |
|
- Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
|
|
| 103 |
NCT02270957 |
Recruiting |
Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches |
- Systemic Lupus Erythematosus
|
- Biological: Abatacept
- Other: Placebo
|
Interventional
|
Phase 2 |
- Oklahoma Medical Research Foundation
- Bristol-Myers Squibb
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- BILAG-based Combined Lupus Assessment (BICLA)
- BICLA and SRI at each month
- Mean SLEDAI at baseline vs 6 months
- (and 3 more...)
|
60 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02270957 |
OMRF 13-38 |
ABC |
January 2014 |
December 2018 |
December 2019 |
October 22, 2014 |
December 7, 2017 |
|
- Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
|
|
| 104 |
NCT02066311 |
Recruiting |
Nelfinavir in Systemic Lupus Erythematosus |
- Systemic Lupus Erythematosus
|
|
Interventional
|
Phase 2 |
- Northwell Health
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- inhibition of anti-dsDNA binding
|
43 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02066311 |
NISLE |
NISLE |
September 2014 |
June 2018 |
June 2018 |
February 19, 2014 |
July 21, 2017 |
|
- Cedars-Sinai Medical Center
Los Angeles, California, United States - UCLA David Geffen School of Medicine
Los Angeles, California, United States - Rush University Medical Center
Chicago, Illinois, United States - (and 5 more...)
|
|
| 105 |
NCT03559465 |
Not yet recruiting
New |
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis. |
|
- Procedure: skin biopsy
- Other: Blood punction
|
Interventional
|
Not Applicable |
- University Hospital, Lille
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Fibroblast transcriptomic : myofibroblast signature
- Fibroblast transcriptomic
|
61 |
All |
18 Years and older (Adult, Older Adult) |
NCT03559465 |
2016_63
2017-A02720-53 |
SCLERO-LB |
September 2018 |
December 2021 |
December 2021 |
June 18, 2018 |
June 18, 2018 |
|
|
|
| 106 |
NCT03543956 |
Recruiting
New |
Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition |
|
- Behavioral: Questionnaire
|
Observational
|
|
- University Hospital, Bordeaux
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Analyse type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix
|
459 |
All |
18 Years and older (Adult, Older Adult) |
NCT03543956 |
CHUBX 2018/09 |
VISSEXPOSITION |
June 4, 2018 |
December 2018 |
December 2018 |
June 1, 2018 |
June 7, 2018 |
|
- CHU de Bordeaux - service de rhumatologie
Bordeaux, France
|
|
| 107 |
NCT03537105 |
Not yet recruiting
New |
Analysis of Cytokine Expression Pattern in Systemic Sclerosis |
|
|
Interventional
|
Not Applicable |
- Poitiers University Hospital
- University of Poitiers
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Skin IL-34 mRNA expression levels
- Immunostainings against IL-34 and other cytokines on skin sections
- Protein expression levels of IL-34 and other cytokines by ELISA
- Skin IL-34 mRNA expression levels of other cytokines
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT03537105 |
SCLEROKINE |
SCLEROKINE |
June 1, 2018 |
June 1, 2019 |
January 1, 2020 |
May 25, 2018 |
May 25, 2018 |
|
|
|
| 108 |
NCT03512873 |
Not yet recruiting |
A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum |
|
|
Interventional
|
Early Phase 1 |
- The First Affiliated Hospital with Nanjing Medical University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Measure the volume change of skin lesions by ultrasound
|
56 |
All |
18 Years and older (Adult, Older Adult) |
NCT03512873 |
MH Hou |
|
June 2018 |
June 2020 |
December 2020 |
May 1, 2018 |
May 1, 2018 |
|
|
|
| 109 |
NCT03482219 |
Recruiting |
Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis |
|
- Other: Occupational therapy
- Other: Home app intervention
|
Interventional
|
Not Applicable |
- University of Michigan
- Scleroderma Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- quickDASH
- Physical Function
- Total Hand Function
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT03482219 |
HUM00141111 |
REACH |
April 16, 2018 |
February 28, 2020 |
March 31, 2020 |
March 29, 2018 |
May 1, 2018 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
|
| 110 |
NCT03419208 |
Recruiting |
Scleroderma Patient-centered Intervention Network (SPIN) Hand Program |
- Scleroderma
- Systemic Sclerosis
|
|
Interventional
|
Not Applicable |
- Lady Davis Institute
- Canadian Institutes of Health Research (CIHR)
- The Arthritis Society, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 3-months post-randomization
- Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 6-months post-randomization
- Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 12-months post-randomization
- (and 11 more...)
|
586 |
All |
18 Years and older (Adult, Older Adult) |
NCT03419208 |
12-123A |
SPIN-HAND |
March 12, 2018 |
November 30, 2018 |
March 1, 2020 |
February 1, 2018 |
March 14, 2018 |
|
- Jewish General Hospital
Montreal, Quebec, Canada
|
|
| 111 |
NCT03406988 |
Recruiting |
Autologous Adipose Tissue in the Treatment of Systemic Sclerosis Digital Ulcers |
- Systemic Sclerosis
- Digital Ulcer
|
- Procedure: Autologous fat grafting
- Procedure: Sham procedure
|
Interventional
|
Not Applicable |
- ASST Gaetano Pini-CTO
- Società Italiana di Reumatologia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Digital Ulcer healing
- Pain evaluation by Visual Analogue Scale (VAS)
- Neovascularization evaluation
|
46 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03406988 |
ID Sperimentazione 138 |
ADUL-SSc |
July 18, 2017 |
March 31, 2018 |
March 31, 2018 |
January 23, 2018 |
January 25, 2018 |
|
- UOC Day Hospital Reumatologia, ASST G. Pini-CTO
Milan, Italy
|
|
| 112 |
NCT03398837 |
Recruiting |
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
|
- Drug: Lenabasum 5 mg
- Drug: Lenabasum 20 mg
- Other: Placebo oral capsule
|
Interventional
|
Phase 3 |
- Corbus Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.
- Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.
- Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.
- Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.
|
354 |
All |
18 Years and older (Adult, Older Adult) |
NCT03398837 |
JBT101-SSc-002 |
RESOLVE-1 |
December 18, 2017 |
March 2020 |
March 2020 |
January 16, 2018 |
May 30, 2018 |
|
- Pacific Arthritis Care Center
Los Angeles, California, United States - Stanford University
Palo Alto, California, United States - University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States - (and 6 more...)
|
|
| 113 |
NCT03365869 |
Not yet recruiting |
A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis |
|
|
Interventional
|
Phase 2 |
- Peking University People's Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Number of participants whose modified Rodnan skin score （mRSS）decreasing
- The number of adverse event and severe adverse event occured
|
72 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03365869 |
PKUPH-R-SRL |
|
June 1, 2018 |
December 31, 2018 |
June 30, 2019 |
December 7, 2017 |
December 7, 2017 |
|
|
|
| 114 |
NCT03274076 |
Recruiting |
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) |
- Systemic Sclerosis
- Scleroderma
|
- Drug: Tofacitinib
- Drug: Placebo Oral Tablet
|
Interventional
|
Phase 1
Phase 2 |
- University of Michigan
- Pfizer
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Incidence of adverse events (AEs) and Serious AE (SAEs)
- Number of Grade 3(severe) or higher adverse events that occur throughout the study
- Number of Grade 2 (moderate) or higher adverse events that occur throughout the study
- (and 3 more...)
|
15 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03274076 |
HUM000131837 |
TOFA-SSc |
October 2, 2017 |
December 2018 |
April 2020 |
September 6, 2017 |
October 10, 2017 |
|
- University of Michigan
Ann Arbor, Michigan, United States - University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
|
| 115 |
NCT03271320 |
Recruiting |
Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis |
|
|
Observational
|
|
- University Hospital, Lille
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Visual scale for aesthetic burden
- Satisfaction with Appearance Scale (SWAP)
- Derriford Appearance Scale-59 (DAS)
- Multidimensional Body self Relations Questionnaire (MBSRQ)
|
150 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03271320 |
2014_63
2016-A00735-46 |
SCLERO-ESTHET |
December 19, 2016 |
December 2019 |
December 2019 |
September 5, 2017 |
April 20, 2018 |
|
- Hôpital Claude Huriez, CHRU
Lille, France
|
|
| 116 |
NCT03268330 |
Not yet recruiting |
Role of Macrophage Migratory Inhibitory Factor in Systemic Sclerosis |
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation between Migration Inhibitory Factor and some of the clinical manifestations of Systemic Sclerosis.
|
40 |
All |
17 Years to 70 Years (Child, Adult, Older Adult) |
NCT03268330 |
ROMMIFISS |
|
October 1, 2017 |
September 2018 |
October 2018 |
August 31, 2017 |
September 8, 2017 |
|
- Assiut University Hospital
Assiut, Egypt
|
|
| 117 |
NCT03257878 |
Recruiting |
Health-related Quality of Life in Korean Patients With Rheumatic Diseases |
|
- Other: validated Korean version of the SF36 and EQ-5D
|
Observational
|
|
- Seoul National University Hospital
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- comparison of physical component scores (PCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
- comparison of mental component scores (MCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
- comparison of physical functioning (PF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
- (and 8 more...)
|
500 |
All |
18 Years and older (Adult, Older Adult) |
NCT03257878 |
H-1701-023-821 |
|
March 31, 2017 |
December 31, 2017 |
December 31, 2017 |
August 22, 2017 |
August 22, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
|
| 118 |
NCT03222492 |
Recruiting |
Brentuximab Vedotin for Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
- Scleroderma
- dcSSc
|
- Biological: Brentuximab Vedotin
- Biological: Placebo
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Immune Tolerance Network (ITN)
- Seattle Genetics, Inc.
|
NIH / Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Proportion of participants who experience at least one Grade 3 or higher adverse event
- Proportion of participants who experience at least one Grade 2 or higher adverse event
- Proportion of participants with Grade 2 or higher peripheral neuropathy
- (and 3 more...)
|
24 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03222492 |
DAIT ITN075AI
ITN075AI |
BRAVOS |
September 20, 2017 |
September 2020 |
September 2020 |
July 19, 2017 |
April 27, 2018 |
|
- UCLA Medical Center: Division of Rheumatology
Los Angeles, California, United States - Georgetown University Medical Center: Division of Rheumatology
Washington, District of Columbia, United States - Boston University School of Medicine: Rheumatology Section, Scleroderma Clinical Centers
Boston, Massachusetts, United States - (and 6 more...)
|
|
| 119 |
NCT03221257 |
Recruiting |
Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate |
- Scleroderma, Systemic
- Interstitial Lung Disease
|
- Drug: Pirfenidone (PFD)
- Drug: Placebo (Plac)
- Drug: Mycophenolate Mofetil (MMF)
|
Interventional
|
Phase 2 |
- Michael Roth
- University of Michigan
- Genentech, Inc.
- University of California, Los Angeles
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percent predicted forced vital capacity (FVC-%)
|
150 |
All |
18 Years and older (Adult, Older Adult) |
NCT03221257 |
UCLA-SLS3 |
SLSIII |
November 28, 2017 |
April 2021 |
May 2021 |
July 18, 2017 |
June 1, 2018 |
|
- University of California Los Angeles
Los Angeles, California, United States - University of Colorado
Aurora, Colorado, United States - Northwestern University
Chicago, Illinois, United States - (and 3 more...)
|
|
| 120 |
NCT03211793 |
Not yet recruiting |
Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis |
- Systemic Sclerosis
- Digital Ulcer
|
- Drug: Mesenchymal stromal cells
- Other: Placebo
|
Interventional
|
Phase 1
Phase 2 |
- UMC Utrecht
- ZonMw: The Netherlands Organisation for Health Research and Development
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Toxicity of the treatment
- Serious adverse events
- Change in perceived pain based on the Numerical Rating Scale
- (and 17 more...)
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT03211793 |
MANUS
2015-000168-32 |
MANUS |
November 2018 |
November 1, 2020 |
November 1, 2020 |
July 7, 2017 |
June 7, 2018 |
|
- Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
|
|
| 121 |
NCT01781611 |
Recruiting |
Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE) |
- Systemic Lupus Erythematosus
|
- Drug: extended release dipyridamole 200mg/aspirin 25mg
- Drug: 81mg aspirin
|
Interventional
|
Not Applicable |
- Oklahoma Medical Research Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- British Isles Lupus Assessment Group Responder Index (BICLA)
- Time to first flare
- Systemic Responder Index (SRI) 4/5
- (and 7 more...)
|
50 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01781611 |
IRB# 12-10 |
DARE |
February 2013 |
February 2019 |
February 2020 |
February 1, 2013 |
September 18, 2017 |
|
- Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
|
|
| 122 |
NCT03120533 |
Recruiting |
Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study |
|
- Drug: Iontophoresis of treprostinil
- Drug: Iontophoresis of placebo
|
Interventional
|
Phase 1
Phase 2 |
- University Hospital, Grenoble
- Linksium
- University Grenoble Alps
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of side-effects graduated according to NIH CTCAE 4.03
- Pharmacodynamical effect of iontophoresis of treprostinil hydrogel in healthy volunteers on pulp finger, leg and foot
- Pharmacodynamical effect of 10 days of iontophoresis of treprostinil hydrogel in systemic sclerosis patients
- (and 2 more...)
|
36 |
All |
18 Years and older (Adult, Older Adult) |
NCT03120533 |
38RC16.005 |
TISSUE-PoC |
June 20, 2017 |
February 2019 |
June 2019 |
April 19, 2017 |
October 27, 2017 |
|
- Grenoble Alps University Hospital
Grenoble, France
|
|
| 123 |
NCT03068234 |
Not yet recruiting |
Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis |
|
- Drug: Pirfenidone
- Drug: Placebo oral capsule
- Drug: Steroids
|
Interventional
|
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Modified Rodnan Skin Score (mRSS）
- Modified Rodnan Skin Score
- Assessment of chest CT
- (and 7 more...)
|
72 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03068234 |
[2017]17 |
|
May 2017 |
April 2019 |
December 2019 |
March 1, 2017 |
March 1, 2017 |
|
- RenJi Hospital
Shanghai, Shanghai, China
|
|
| 124 |
NCT03041025 |
Recruiting |
Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis |
|
- Drug: GSK2330811
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of participants with any adverse event (AE) and any serious adverse event (SAE) as a measure of safety and tolerability
- Hematology assessed as a measure of safety and tolerability
- Clinical chemistry assessed as a measure of safety and tolerability
- (and 12 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03041025 |
201247 |
|
June 5, 2017 |
July 15, 2019 |
July 15, 2019 |
February 2, 2017 |
June 15, 2018 |
|
- GSK Investigational Site
Los Angeles, California, United States - GSK Investigational Site
Chicago, Illinois, United States - GSK Investigational Site
Baltimore, Maryland, United States - (and 9 more...)
|
|
| 125 |
NCT02921971 |
Recruiting |
Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis |
|
- Drug: SAR156597 (ACT14604)
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in mRSS
- Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), assessed with SHAQ
- Change from baseline in respiratory function as measured by observed Forced Vital Capacity (FVC)
- Change from baseline in observed Carbon Monoxide Diffusing Lung Capacity (DLco [corrected for hemoglobin])
|
94 |
All |
18 Years and older (Adult, Older Adult) |
NCT02921971 |
ACT14604
2016-001028-80
U1111-1179-4690 |
|
November 2016 |
October 2018 |
April 2, 2019 |
October 3, 2016 |
June 15, 2018 |
|
- Investigational Site Number 8400006
San Francisco, California, United States - Investigational Site Number 8400005
Washington, District of Columbia, United States - Investigational Site Number 8400003
Baltimore, Maryland, United States - (and 48 more...)
|
|
| 126 |
NCT02915835 |
Recruiting |
Riociguat in Scleroderma Associated Digital Ulcers |
- Scleroderma
- Digital Ulcers
|
- Drug: Riociguat
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Dinesh Khanna, MD, MS
- Bayer
- University of Michigan
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The primary efficacy outcome is the change from baseline to end of double-blind treatment in digital ulcer net burden.
- Healing of cardinal DU
- Development of DU
- (and 10 more...)
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT02915835 |
BAY63-2521 |
RESCUE |
September 2016 |
October 2018 |
October 2018 |
September 27, 2016 |
May 10, 2017 |
|
- Georgetown University
Washington, D.C., District of Columbia, United States - University of Michigan
Ann Arbor, Michigan, United States - Hospital of Special Surgery (HSS)
New York, New York, United States - (and 2 more...)
|
|
| 127 |
NCT02821663 |
Recruiting |
Vocal Intervention in Systemic Sclerosis |
|
- Behavioral: vocal intervention
|
Interventional
|
Not Applicable |
- Medical University of Vienna
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MOS 36-Item Short Form Health Survey
- Mouth open; in millimeter
- 6-minutes walk test
- (and 2 more...)
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT02821663 |
SSc-1-MM |
|
November 2014 |
October 2017 |
February 2018 |
July 1, 2016 |
April 13, 2017 |
|
- Department of Physical Medicine and Rehabilitation, Medical University of Vienna
Vienna, Austria
|
|
| 128 |
NCT01532310 |
Recruiting |
Belimumab (BENLYSTA®) Pregnancy Registry |
- Systemic Lupus Erythematosus
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Birth defects
- Other pregnancy outcomes
- Infant outcomes
|
500 |
Female |
Child, Adult, Older Adult |
NCT01532310 |
114256
WEUKBRE6076 |
|
July 16, 2012 |
November 26, 2021 |
November 26, 2021 |
February 14, 2012 |
August 9, 2017 |
|
- GSK Investigational Site
Wilmington, North Carolina, United States
|
|
| 129 |
NCT02636127 |
Recruiting |
Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis |
|
|
Interventional
|
Not Applicable |
- Assistance Publique Hopitaux De Marseille
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- blood sample will be done for dosage of Fractalkine in the serum
- blood sample for functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT02636127 |
2015-37 |
|
December 2015 |
January 2017 |
June 2017 |
December 21, 2015 |
July 7, 2016 |
|
- Assistance Publique Hopitaux de Marseille
Marseille, France
|
|
| 130 |
NCT02558543 |
Recruiting |
Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis |
|
- Drug: Stromal Vascular fraction
- Drug: Ringer lactate
|
Interventional
|
Phase 2 |
- Assistance Publique Hopitaux De Marseille
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Cochin hand functional scale
- the pain in the hands (EVA pain scale),
- the quality of life- score adapted to scleroderma (SHAQ)
- (and 6 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT02558543 |
2014-003321-17 |
scleradec2 |
September 2015 |
May 2017 |
September 2017 |
September 24, 2015 |
July 7, 2016 |
|
- Assistance Publique Hopitaux de Marseille
Marseille, France
|
|
| 131 |
NCT02551042 |
Recruiting |
CSL Behring Sclero XIII |
|
- Drug: Fibrogammin®P, coagulation factor XIII concentrate (Human)
- Drug: 0.9% sodium chloride
|
Interventional
|
Phase 2 |
- University College, London
- CSL Behring
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Primary outcome assessed by skin involvement measured with modified Rodnan skin score
- Primary outcome assessed by skin involvement measured with Raynaud condition score
- Pulmonary function measured by pulmonary function test
- (and 14 more...)
|
26 |
All |
18 Years and older (Adult, Older Adult) |
NCT02551042 |
13/0417
2014-001101-40 |
|
September 2015 |
September 2016 |
September 2018 |
September 16, 2015 |
May 30, 2016 |
|
- Royal Free London NHS Foundation Trust
London, United Kingdom
|
|
| 132 |
NCT02484053 |
Recruiting |
Rapid Infusion Rituximab, Hematologic, Oncologic, and Rheumatologic Disorders |
- Hematologic Disorders
- Oncologic Disorders
- Rheumatologic Disorders
|
|
Interventional
|
Early Phase 1 |
- Baylor College of Medicine
- Texas Children's Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the safety of rapid infusion rituximab in a pilot group of adolescent patients for hematologic, oncologic, and rheumatologic disorders.
- To determine the incidence of infusion-related reactions with the administration of rapid infusion rituximab
|
20 |
All |
1 Year to 19 Years (Child, Adult) |
NCT02484053 |
H-35628 Rituximab |
|
June 2015 |
June 2020 |
|
June 29, 2015 |
August 10, 2016 |
|
- Texas Children's Hospital
Houston, Texas, United States
|
|
| 133 |
NCT02370693 |
Recruiting |
Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis |
- Interstitial Lung Disease
- ILD
- Systemic Sclerosis
- Scleroderma
|
- Drug: Bortezomib
- Drug: Placebo
- Drug: Mycophenolate mofetil
|
Interventional
|
Phase 2 |
- Northwestern University
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Safety and Tolerability of bortezomib with mycophenolate mofetil assessed by the incidence of serious adverse events
- Effect of bortezomib with mycophenolate mofetil on quality of life measured by Promis-29 SF-36, and St. George Respiratory Dyspnea Score questionnaires
- Effect of bortezomib with mycophenolate mofetil on skin fibrosis measured by the Modified Rodnan Skin Score
- Effect of bortezomib with mycophenolate mofetil on lung function measured by change in Forced Vital Capacity during pulmonary function tests
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT02370693 |
R34
1R34HL122558-01A1 |
|
March 2016 |
November 2017 |
November 2017 |
February 25, 2015 |
January 24, 2017 |
|
- Northwestern University
Chicago, Illinois, United States
|
|
| 134 |
NCT03530540 |
Recruiting
New |
Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease. |
|
- Device: low-intensity extracorporeal shockwave therapy
- Device: Placebo LI-ESWT
- Device: Penile pump
|
Interventional
|
Not Applicable |
- Odense University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in penile curvature
- Change in pain score using the Visual Analogue Scale (VAS)
- Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5).
- Change in Peyronies disease questionnaire score
|
50 |
Male |
18 Years and older (Adult, Older Adult) |
NCT03530540 |
20170201 |
|
March 13, 2018 |
October 1, 2018 |
February 1, 2019 |
May 21, 2018 |
May 21, 2018 |
|
- Odense university hospital
Odense, Denmark
|
|
| 135 |
NCT01895244 |
Recruiting |
Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis |
- Scleroderma
- Cardiac Involvement
- Autologous Stem Cell Transplantation
|
- Drug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells
|
Interventional
|
Phase 2 |
- University Hospital Tuebingen
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Treatment related mortality
- Time to engraftment
- (and 2 more...)
|
44 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01895244 |
AST MOMA |
AST-MOMA |
September 2012 |
September 2020 |
September 2022 |
July 10, 2013 |
May 9, 2018 |
|
- University Hospital Tuebingen; Department of oncology, hematology, rheumatology, immunology and pulmology
Tuebingen, Germany
|
|
| 136 |
NCT01848418 |
Recruiting |
Conception of an ICF Core Set for Systemic Sclerosis |
|
|
Observational
|
|
- Assistance Publique - Hôpitaux de Paris
- Cabinet d’étude INTERLIS
- Ecole des Hautes Etudes en Santé Publique
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Validation of an ICF core Set for Systemic sclerosis
- Translation of concepts identified such as items ICF (linking).
- Creation of a database from a qualitative survey
|
130 |
All |
18 Years and older (Adult, Older Adult) |
NCT01848418 |
AOR - 10050 |
SCISCIF |
October 27, 2012 |
October 2018 |
November 2018 |
May 7, 2013 |
March 2, 2018 |
|
- Cochin Hospital
Paris, France
|
|
| 137 |
NCT03268421 |
Recruiting |
Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia |
- Fibromyalgia
- Myofascial Pain Syndrome
- Muscular Diseases
- (and 2 more...)
|
- Behavioral: Fibromyalgia Integrative Training for Teens
- Behavioral: Cognitive Behavioral Therapy
- Behavioral: Graded Aerobic Exercise
|
Interventional
|
Not Applicable |
- Children's Hospital Medical Center, Cincinnati
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in functional disability
- Change in pain intensity
|
420 |
All |
12 Years to 18 Years (Child, Adult) |
NCT03268421 |
CIN001-FIT Teens
R01AR070474 |
FIT Teens |
January 2, 2018 |
May 2022 |
January 2023 |
August 31, 2017 |
March 21, 2018 |
|
- Connecticut Children's Medical Center
Hartford, Connecticut, United States - University of Louisville
Louisville, Kentucky, United States - Boston Chilldren's Hospital
Boston, Massachusetts, United States - (and 4 more...)
|
|
| 138 |
NCT01804959 |
Recruiting |
Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease |
|
- Dietary Supplement: Vivomixx probiotics
|
Interventional
|
Phase 2 |
- Singapore General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.
- mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment.
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT01804959 |
AL-SScGI |
|
May 2013 |
August 2018 |
August 2018 |
March 5, 2013 |
October 11, 2017 |
|
- Singapore General Hospital
Singapore, Singapore
|
|
| 139 |
NCT00756769 |
Recruiting |
Systemic Lupus Erythematosus in Gullah Health |
- Systemic Lupus Erythematosus
|
|
Observational
|
|
- Medical University of South Carolina
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
750 |
All |
2 Years and older (Child, Adult, Older Adult) |
NCT00756769 |
MUSC HR10852
P60AR049459 |
SLEIGH |
April 2003 |
April 2020 |
April 2020 |
September 22, 2008 |
February 6, 2018 |
|
- Medical College of Georgia
Augusta, Georgia, United States - Medical University of South Carolina
Charleston, South Carolina, United States
|
|
| 140 |
NCT00750971 |
Recruiting |
Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST) |
- Systemic Lupus Erythematosus
|
- Procedure: Immunoablation and Autologous Hematopoietic Stem Cell Transplantation
|
Interventional
|
Phase 2 |
- Charite University, Berlin, Germany
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- SLEDAI
- Serologic response (autoantibodies)
- Immune Reconstitution
- Organ-specific response parameters
|
30 |
All |
18 Years to 60 Years (Adult) |
NCT00750971 |
CT-1306 |
ASSIST |
August 2008 |
July 2020 |
August 2020 |
September 11, 2008 |
March 20, 2017 |
|
- Universitätsmedizin Charité
Berlin, Germany - Universitätsklinik Düsseldorf
Düsseldorf, Germany - Universitätsklinikum Essen
Essen, Germany - (and 5 more...)
|
|
| 141 |
NCT03092141 |
Recruiting |
Physical Training in Patients With Relapsing Polychondritis |
|
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cardiopulmonary test
- Strength muscle tests
- Healthy Assessment Questionnaire (HAQ)
- (and 2 more...)
|
12 |
All |
18 Years and older (Adult, Older Adult) |
NCT03092141 |
MYO-HCFMUSP-04 |
|
January 2017 |
January 2020 |
January 2020 |
March 27, 2017 |
May 10, 2018 |
|
- Samuel Katsuyuki Shinjo
Sao Paulo, Brazil
|
|
| 142 |
NCT01639573 |
Recruiting |
Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic Sclerosis |
|
|
Observational
|
|
- Children's Hospital Los Angeles
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
3 |
All |
8 Years to 18 Years (Child, Adult) |
NCT01639573 |
CAMPATH-1H SSc |
CAMPATH-1H |
April 2011 |
January 2020 |
January 2020 |
July 12, 2012 |
January 25, 2018 |
|
- Childrens Hospitla Los Angeles
Los Angeles, California, United States
|
|
| 143 |
NCT02771600 |
Recruiting |
Pilot Study of a New Device (Buzzy®) for Procedural Pain Relief During Needle-Related Procedures in Paediatric Patients |
- Autoimmune Rheumatologic Disease
- Immune Deficiency
- Pain Due to Certain Specified Procedures
- Child/Adolescent Problems
|
- Device: Buzzy
- Drug: Topical anaesthetic cream
|
Interventional
|
Not Applicable |
- St. Justine's Hospital
- Toronto-Dominion Bank of Canada Funds for Clinical Research projects.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Post-procedural Pain
- Anxiety level
- Satisfaction of the parents, children and nurses
- Process time of the needle-related procedure
|
100 |
All |
4 Years to 17 Years (Child) |
NCT02771600 |
4137 |
|
October 2016 |
September 2017 |
December 2017 |
May 13, 2016 |
October 27, 2016 |
|
- CHU Ste-Justine's
Montréal, Quebec, Canada
|
|
| 144 |
NCT00512694 |
Recruiting |
Duke Lupus Registry |
- Systemic Lupus Erythematosus
- Cutaneous Lupus
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
1000 |
All |
18 Years and older (Adult, Older Adult) |
NCT00512694 |
Pro00008875
8652-07-6R1 |
|
July 2007 |
June 2019 |
|
August 8, 2007 |
July 28, 2017 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 145 |
NCT01445821 |
Recruiting |
Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial |
|
- Biological: Peripheral Blood Stem Cells
- Drug: Cyclophosphamide
- Drug: Mesna
- (and 4 more...)
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to Treatment Failure
- Survival
|
160 |
All |
17 Years to 60 Years (Child, Adult) |
NCT01445821 |
ASSIST IIb |
DIScl2011 |
September 2011 |
December 2018 |
September 2019 |
October 4, 2011 |
March 29, 2018 |
|
- Northwestern University
Chicago, Illinois, United States
|
|
| 146 |
NCT01611636 |
Recruiting |
Clinical Characteristics of Allergy, Autoimmune and Rheumatic Diseases: A Ten Year Retrospective Study |
- Allergy
- Autoimmune Diseases
- Rheumatic Diseases
|
|
Observational
|
|
- Far Eastern Memorial Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Incidence of target diseases
|
200000 |
All |
Child, Adult, Older Adult |
NCT01611636 |
100165-E |
|
January 2012 |
January 2022 |
January 2022 |
June 5, 2012 |
August 19, 2015 |
|
- Far Eastern Memorial Hospital
New Taipei City, Taiwan
|
|
| 147 |
NCT00001372 |
Recruiting |
Study of Systemic Lupus Erythematosus |
- Systemic Lupus Erythematosus
|
|
Observational
|
|
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Other
|
|
99999999 |
All |
Child, Adult, Older Adult |
NCT00001372 |
940066
94-AR-0066 |
|
February 2, 1994 |
|
|
November 4, 1999 |
May 21, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 148 |
NCT00812838 |
Recruiting |
H-22411: BOTOX® for Peyronie's Disease |
|
- Drug: 100 units of Botulinum Toxin Type A
- Other: Preservative free normal saline
|
Interventional
|
Phase 2 |
- Mohit Khera
- Allergan
- Baylor College of Medicine
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in penile curvature
- Improvements in penile blood flow
- Reduction in penile plaque size as seen on ultrasound
- Changes in IIEF (International Index of Erectile Function) scores
|
20 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00812838 |
11-07-40-04 |
|
February 2009 |
July 2017 |
January 2018 |
December 22, 2008 |
November 9, 2016 |
|
- Baylor College of Medicine
Houston, Texas, United States
|
|
| 149 |
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
|
|
| 150 |
NCT03196115 |
Recruiting |
BioHFS - Biomarker for Hyaline Fibromatosis Syndrome |
- Hyaline Fibromatosis Syndrome
- Hyalinosis
- Hyaline Membrane Disease
- (and 3 more...)
|
|
Observational
|
|
- University of Rostock
- Centogene AG Rostock
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The diagnosis of Hyaline fibromatosis syndrome measured by sequencing of Hyaline fibromatosis syndrome
- Number of correct identified patients with Hyaline fibromatosis syndrome
|
20 |
All |
2 Months and older (Child, Adult, Older Adult) |
NCT03196115 |
BHFS 03-2017 |
BioHFS |
June 20, 2017 |
June 2020 |
July 2020 |
June 22, 2017 |
July 5, 2017 |
|
- Albrecht-Kossel-Institute for Neuroregeneration (AKos) Centre for Mental Health Disease University of Rostock
Rostock, Germany
|
|
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