1 |
NCT03340194 |
Not yet recruiting |
Evaluation of Calcinosis in Systemic Sclerosis |
|
- Radiation: Radiography
- Procedure: Veinous punction
|
Observational |
|
- University Hospital, Lille
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Calcinosis cutis prevalence by radiographic assessment
- Demographic data
- Rodnan score
- (and 5 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03340194 |
2016_43 2017-A01822-51 |
CALCIDERMIS |
December 2017 |
June 2019 |
June 2019 |
November 13, 2017 |
November 13, 2017 |
|
|
2 |
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) |
NCT03271320 |
2014_63 2016-A00735-46 |
SCLERO-ESTHET |
December 19, 2016 |
December 2019 |
December 2019 |
September 5, 2017 |
September 5, 2017 |
|
- Hôpital Claude Huriez, CHRU
Lille, France
|
3 |
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, Senior) |
NCT01848418 |
AOR - 10050 |
SCISCIF |
October 27, 2012 |
October 2018 |
November 2018 |
May 7, 2013 |
March 2, 2018 |
|
- Cochin Hospital
Paris, France
|
4 |
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, Senior) |
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
|
5 |
NCT03143413 |
Recruiting |
Echo Systemic Sclerosis |
- Systemic Sclerosis
- Gougerot Sjogren Syndrome
- Sicca-Asthenia-Polyalgia Syndrome
|
|
Observational |
|
- University Hospital, Clermont-Ferrand
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Jousse-Joulin ultrasonography score
- Ultrasonography score equal or higher than 2 on at least one salivary gland
- Ultrasonography score equal or higher than 3 on at least one salivary gland
- (and 2 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03143413 |
CHU-323 2016-A01256-45 |
|
March 24, 2017 |
March 2019 |
May 2019 |
May 8, 2017 |
May 8, 2017 |
|
- CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, France
|
6 |
NCT00622895 |
Recruiting |
Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis |
- Systemic Scleroderma
- Severe Systemic Sclerosis
|
- Drug: fludarabine phosphate
- Drug: Mycophenolic Acid
- Drug: tacrolimus
- (and 8 more...)
|
Interventional |
Phase 1 Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Event-free survival (EFS)
- EFS
- Overall survival
- (and 9 more...)
|
20 |
All |
up to 70 Years (Child, Adult, Senior) |
NCT00622895 |
2067.00 NCI-2011-01352 R01AI041721 |
|
September 2006 |
March 2018 |
|
February 25, 2008 |
March 8, 2017 |
|
- Colorado Blood Cancer Institute
Denver, Colorado, United States - Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
7 |
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, Senior) |
NCT03398837 |
JBT101-SSc-002 |
RESOLVE-1 |
December 18, 2017 |
March 2020 |
March 2020 |
January 16, 2018 |
April 19, 2018 |
|
- Pacific Arthritis Care Center
Los Angeles, California, United States - Stanford University
Palo Alto, California, United States - John Hopkins University, Scleroderma Center
Baltimore, Maryland, United States - (and 4 more...)
|
8 |
NCT03374618 |
Recruiting |
Neutrophil Extracellular Traps in Systemic Sclerosis |
- Systemic Lupus Erythematosus
- Systemic Sclerosis
|
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Quantification of neutrophil extracellular traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, SLE and healthy controls.
- Analysis of the composition of neutrophil extracellular traps
- Analysis of the cytokines influencing NETs production in vitro
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT03374618 |
PO17014 |
NET-SSC |
October 6, 2017 |
October 6, 2019 |
October 7, 2019 |
December 15, 2017 |
December 15, 2017 |
|
- Damien JOLLY
Reims, France
|
9 |
NCT03459716 |
Not yet recruiting |
Endothelial Biomarkers of Systemic Sclerosis-associated Pulmonary Hypertension |
- Scleroderma
- Pulmonary Hypertension
|
|
Observational |
|
- Louisiana State University Health Sciences Center in New Orleans
- Scleroderma Foundation
- Tulane University Health Sciences Center
- University Medical Center-New Orleans
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Composite pulmonary hypertension detection score
|
56 |
All |
18 Years and older (Adult, Senior) |
NCT03459716 |
IRB 10033SM |
BOSS-PH |
April 1, 2018 |
April 1, 2021 |
April 1, 2021 |
March 9, 2018 |
March 12, 2018 |
|
|
10 |
NCT02371005 |
Recruiting |
Oral Manifestations of Systemic Sclerosis |
|
- Radiation: Cone Beam Computed Tomography (CBCT)
|
Interventional |
Not Applicable |
- University Hospital, Strasbourg, France
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Measurement of the periodontal ligament space width at mid-root level on Cone Beam Computed Tomography (CBCT) axial views
- Radiographic analysis of oro-facial manifestations associated with systemic sclerosis using high-resolution volumetric Cone Beam Computed Tomography (CBCT) exploration
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT02371005 |
6026 |
|
June 2015 |
June 2019 |
June 2019 |
February 25, 2015 |
September 11, 2017 |
|
- Service de parodontologie
Strasbourg, France
|
11 |
NCT02981082 |
Recruiting |
Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension |
- Systemic Sclerosis
- Pulmonary; Hypertension
|
- Drug: Dimethyl Fumarate (DMF)
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 1 |
- University of Pittsburgh
- Biogen
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- 6 minute walk distance (6MWD).
- Clinical Worsening
- Borg Dyspnea Index (BDI)
- (and 2 more...)
|
34 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02981082 |
PRO16070614 |
|
December 2016 |
November 2019 |
May 2020 |
December 2, 2016 |
January 5, 2018 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
12 |
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, Senior) |
NCT03068234 |
[2017]17 |
|
May 2017 |
April 2019 |
December 2019 |
March 1, 2017 |
March 1, 2017 |
|
- RenJi Hospital
Shanghai, Shanghai, China
|
13 |
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, Senior) |
NCT02636127 |
2015-37 |
|
December 2015 |
January 2017 |
June 2017 |
December 21, 2015 |
July 7, 2016 |
|
- Assistance Publique Hopitaux de Marseille
Marseille, France
|
14 |
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
|
15 |
NCT02556697 |
Recruiting |
In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients |
- Pulmonary Disease
- Pulmonary Emphysema
|
- Device: Bronchoscopy with in vivo confocal endomicroscopy
|
Interventional |
Not Applicable |
- University Hospital, Rouen
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma
- Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma
- Measurement of length of the capillary portions of patient with pulmonary emphysema or pulmonary scleroderma
- (and 2 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02556697 |
2013/093/HP |
MiPECSE |
December 2014 |
December 2018 |
December 2018 |
September 22, 2015 |
December 7, 2016 |
|
- Rouen University Hospital
Rouen, France
|
16 |
NCT03198689 |
Not yet recruiting |
Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
|
- Drug: Brentuximab Vedotin
|
Interventional |
Phase 2 |
- Lawson Health Research Institute
- Seattle Genetics, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in skin thickness measured by modified Rodnan Skin Score (mRSS)
- Change in mRSS
- CRISS score >20%
- (and 5 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT03198689 |
BV201708 |
|
September 1, 2018 |
November 1, 2018 |
June 1, 2019 |
June 26, 2017 |
March 7, 2018 |
|
- Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, Canada
|
17 |
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, Senior) |
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
|
18 |
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, Senior) |
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
|
19 |
NCT02530996 |
Recruiting |
Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment |
|
- Drug: BH4
- Other: Vasculopathy assessment
- Drug: Placebo
|
Observational |
|
- VA Office of Research and Development
|
U.S. Fed |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- FMD variables: resting brachial artery diameter, resting forearm blood flow, reactive hyperemia, sheer rate.
- Vascular smooth muscle reactivity (endothelial independent dilation, EID)
- Tissue ischemia by Near Infrared Spectroscopy (NIRS):
|
32 |
All |
18 Years to 95 Years (Adult, Senior) |
NCT02530996 |
IMMA-006-14F |
Scleroderma |
May 1, 2015 |
May 1, 2019 |
May 1, 2019 |
August 21, 2015 |
February 2, 2018 |
|
- VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
|
20 |
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, Senior) |
NCT03365869 |
PKUPH-R-SRL |
|
June 1, 2018 |
December 31, 2018 |
June 30, 2019 |
December 7, 2017 |
December 7, 2017 |
|
|
21 |
NCT03271333 |
Recruiting |
Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma. |
|
- Other: lung function tests
|
Observational |
|
- University Hospital, Lille
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- composite criteria: forced vital capacity and CO diffusing capacity
|
70 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03271333 |
2015_49 2016-A00722-49 |
SCLERO-PID |
April 10, 2018 |
August 2020 |
August 2020 |
September 5, 2017 |
April 13, 2018 |
|
- Hôpital Claude Huriez, CHU
Lille, France
|
22 |
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, Senior) |
NCT03222492 |
DAIT ITN075AI ITN075AI |
BRAVOS |
September 20, 2017 |
September 2020 |
September 2020 |
July 19, 2017 |
March 8, 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...)
|
23 |
NCT02808481 |
Not yet recruiting |
FOLLOW HEART TRANSPLANT FOR ACHIEVING THE HEART PRIMITIVE RELATED SCLERODERMA SYSTEMIC |
|
|
Observational |
|
- University Hospital, Strasbourg, France
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Analysis of data from patients with systemic sclerosis who used cardiac transplantation for primary cardiac involvement
|
9 |
All |
18 Years and older (Adult, Senior) |
NCT02808481 |
6410 |
|
June 2016 |
December 2016 |
December 2016 |
June 21, 2016 |
June 21, 2016 |
|
|
24 |
NCT01086540 |
Recruiting |
Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) |
- Systemic Sclerosis-Associated PAH
|
- Biological: Rituximab
- Other: Placebo
|
Interventional |
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in pulmonary vascular resistance measured by right heart catheterization
- Safety and tolerability of rituximab therapy using the NCI-CTCAE
- Assessment of time to clinical worsening
- (and 6 more...)
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01086540 |
DAIT ASC01 |
|
August 2010 |
January 2019 |
January 2020 |
March 15, 2010 |
October 10, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Stanford University
Palo Alto, California, United States - UCSF School of Medicine
San Francisco, California, United States - (and 23 more...)
|
25 |
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, Senior) |
NCT03120533 |
38RC16.005 |
TISSUE-PoC |
June 20, 2017 |
February 2019 |
June 2019 |
April 19, 2017 |
October 27, 2017 |
|
- Grenoble Alps University Hospital
Grenoble, France
|
26 |
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, Senior) |
NCT03041025 |
201247 |
|
June 5, 2017 |
July 15, 2019 |
July 15, 2019 |
February 2, 2017 |
March 29, 2018 |
|
- GSK Investigational Site
Chicago, Illinois, United States - GSK Investigational Site
Baltimore, Maryland, United States - GSK Investigational Site
Boston, Massachusetts, United States - (and 7 more...)
|
27 |
NCT03211793 |
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, Senior) |
NCT03211793 |
MANUS 2015-000168-32 |
MANUS |
January 2018 |
September 1, 2019 |
September 1, 2019 |
July 7, 2017 |
October 27, 2017 |
|
- Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
|
28 |
NCT03482219 |
Not yet recruiting New |
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, Senior) |
NCT03482219 |
HUM00141111 |
REACH |
April 2018 |
February 28, 2020 |
March 31, 2020 |
March 29, 2018 |
March 29, 2018 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
29 |
NCT02370784 |
Recruiting |
Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma |
|
- Drug: atorvastatin
- Drug: Placebo
|
Interventional |
Phase 2 |
- Robyn T. Domsic, MD, MPH
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- University of Pittsburgh
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- effect of atorvastatin therapy on change in microvascular endothelial function by Noninvasive vascular testing.
- effect of atorvastatin on change in Raynaud symptoms measured by a patient reported questionnaire.
- effect of atorvastatin on change in microcirculatory flow by Noninvasive vascular testing.
- effect of atorvastatin on change in macrovascular endothelial function by using Noninvasive vascular testing.
|
30 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02370784 |
PRO14010170 1R21AR066305-01A1 |
TAMER |
February 2015 |
February 2019 |
December 2019 |
February 25, 2015 |
March 15, 2018 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
30 |
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, Senior) |
NCT02558543 |
2014-003321-17 |
scleradec2 |
September 2015 |
May 2017 |
September 2017 |
September 24, 2015 |
July 7, 2016 |
|
- Assistance Publique Hopitaux de Marseille
Marseille, France
|
31 |
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, Senior) |
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
|
32 |
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, Senior) |
NCT03268330 |
ROMMIFISS |
|
October 1, 2017 |
September 2018 |
October 2018 |
August 31, 2017 |
September 8, 2017 |
|
- Assiut University Hospital
Assiut, Egypt
|
33 |
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
|
34 |
NCT02663895 |
Recruiting |
A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis |
- Systemic Sclerosis
- Calcinosis
|
|
Interventional |
Phase 2 |
- Stanford University
- United Therapeutics
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess the number of participants with treatment-related adverse events following treatment with oral treprostinil
- To determine the mean rate of change of calcinosis in radiograph following treatment with oral treprostinil as assessed by a novel radiographic scoring system
- To assess the effect of oral treprostinil on the change in Scleroderma Health Assessment Questionnaire (SHAQ)
- (and 8 more...)
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT02663895 |
36140 |
|
October 2016 |
June 2019 |
June 2020 |
January 26, 2016 |
April 19, 2018 |
|
- Stanford University School of Medicine
Palo Alto, California, United States
|
35 |
NCT00074568 |
Recruiting |
Scleroderma Registry |
- Systemic Sclerosis
- Scleroderma
|
|
Observational |
|
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- The University of Texas Health Science Center, Houston
|
NIH / Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Establish National registry of Scleroderma as resource for scleroderma scientific community
|
5000 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00074568 |
NIAMS-108 N01AR02251-000 NO1-AR-0-2251 |
Registry |
September 2000 |
January 2022 |
|
December 17, 2003 |
January 6, 2016 |
|
- University of Texas - Houston Medical School
Houston, Texas, United States
|
36 |
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) |
NCT01895244 |
AST MOMA |
AST-MOMA |
September 2012 |
September 2018 |
September 2020 |
July 10, 2013 |
October 25, 2016 |
|
- University Hospital Tuebingen; Department of oncology, hematology, rheumatology, immunology and pulmology
Tuebingen, Germany
|
37 |
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, Senior) |
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
|
38 |
NCT02896205 |
Recruiting |
Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease |
- Systemic Sclerosis
- Scleroderma
- Interstitial Lung Disease
|
- Drug: Mycophenolate mofetil
- Drug: Placebo
|
Interventional |
Phase 3 |
- Postgraduate Institute of Medical Education and Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in Forced vital capacity (FVC) at 6 months, after treatment with oral mycophenolate mofetil or placebo
- Change from baseline in Quality of Life (QoL) score by Medical Outcome Short Form 36 (SF-36v2) at 6 months
- Change from baseline in Mahler Dyspnoea Index (MDI) at 6 months
- (and 2 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02896205 |
NK/2612/DM/10772 |
MYILD |
October 2016 |
July 2017 |
July 2017 |
September 12, 2016 |
November 8, 2016 |
|
|
39 |
NCT02426229 |
Recruiting |
Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma |
- Scleroderma
- Interstitial Lung Disease
|
- Drug: dabigatran etexilate
|
Interventional |
Phase 1 |
- Medical University of South Carolina
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite: Safety of dabigatran patients with scleroderma interstitial lung disease. (complete blood counts, comprehensive metabolic profile, and coagulation studies).
- Composite: Preliminary estimate of efficacy of dabigatran in scleroderma. (skin score and dermal fibroblast biology)
|
15 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02426229 |
1R21AR065089-01A1 |
|
February 2016 |
August 2017 |
August 2017 |
April 24, 2015 |
March 23, 2017 |
|
- Medical University of South Carolina
Charleston, South Carolina, United States
|
40 |
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, Senior) |
NCT02921971 |
ACT14604 2016-001028-80 U1111-1179-4690 |
|
November 2016 |
October 2018 |
April 2, 2019 |
October 3, 2016 |
April 12, 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...)
|
41 |
NCT02851875 |
Recruiting |
Duke Scleroderma Clinic Patient Registry |
- Scleroderma
- Systemic Sclerosis
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in disease activity as measured by Rodnan Skin Score
- Change in disease activity as measured by patient reported Scleroderma Health Associated Questionnaire (SHAQ)
|
1000 |
All |
18 Years and older (Adult, Senior) |
NCT02851875 |
Pro00067280 |
|
April 2016 |
December 2026 |
December 2026 |
August 2, 2016 |
May 2, 2017 |
|
- Duke University
Durham, North Carolina, United States
|
42 |
NCT03053739 |
Recruiting |
To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis |
- Associated Pulmonary Arterial Hypertension
|
- Drug: Sildenafil 20mg and Bosentan 62.5mg
- Drug: Sildenafil 20mg and Placebo
|
Interventional |
Phase 4 |
- Postgraduate Institute of Medical Education and Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in Pulmonary artery pressures
- 1.Change in 6 Minute walk distance
- Time To Clinical Worsening (TTCW)
- Emergent side effects of Sildenafil and Bosentan
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03053739 |
MK/2927/DM/9430 |
BosSilSS |
December 2016 |
December 2017 |
December 2017 |
February 15, 2017 |
February 15, 2017 |
|
- Dr Preksha Dwivedi
Chandigarh, India
|
43 |
NCT03058887 |
Recruiting |
The Effects of Exercise in Patients With Systemic Sclerosis |
- Systemic Sclerosis
- Raynaud's Phenomenon
- Quality of Life
|
- Other: Exercise intervention - Cycling
- Other: Exercise intervention - arm cranking
|
Interventional |
Not Applicable |
- Sheffield Hallam University
- Sheffield Teaching Hospitals NHS Foundation Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Part I (Pilot study): Microcirculation in the digital area
- Part II (Feasibility study): Feasibility of a combined exercise protocol (aerobic with resistance training).
- Part II (Feasibility study): Assessment of Quality of life
- (and 3 more...)
|
36 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03058887 |
IRAS: 68096 |
|
June 2016 |
September 2018 |
September 2018 |
February 23, 2017 |
February 23, 2017 |
|
- Sheffield Hallam University
Sheffield, United Kingdom - Royal Hallamshire Hospital
Sheffield, United Kingdom
|
44 |
NCT02213705 |
Recruiting |
Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells |
- SYSTEMIC SCLERODERMA
- ALLOGENEIC MESENCHYMAL STEM CELLS
- ADULT
|
- Biological: INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS
|
Interventional |
Phase 1 Phase 2 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- toxicity
- survival
- progression free survival
- (and 2 more...)
|
20 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02213705 |
MSC Severe Systemic Sclerosis |
MSC |
June 2014 |
June 2018 |
June 2019 |
August 11, 2014 |
April 18, 2016 |
|
- Saint-Louis Hospital
Paris, France
|
45 |
NCT01656447 |
Recruiting |
Scleroderma Registry & Repository at the Hospital for Special Surgery |
|
|
Observational |
|
- Hospital for Special Surgery, New York
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Modified Rodnan Skin Score
- Scleroderma Health Assessment Questionnaire
- Short Form-36
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT01656447 |
2014-276 |
|
August 2006 |
January 2030 |
|
August 3, 2012 |
March 15, 2018 |
|
- Hospital for Special Surgery
New York, New York, United States
|
46 |
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, Senior) |
NCT01804959 |
AL-SScGI |
|
May 2013 |
August 2018 |
August 2018 |
March 5, 2013 |
October 11, 2017 |
|
- Singapore General Hospital
Singapore, Singapore
|
47 |
NCT03438032 |
Not yet recruiting |
Identifying Unique Pathogenic Macrophages in Systemic Sclerosis-ILD |
- Fibrosis Lung
- Systemic Sclerosis
|
- Diagnostic Test: Bronchoscopy with lavage
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Single-cell RNA-seq analysis
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03438032 |
SP0044402 |
|
May 1, 2018 |
February 1, 2020 |
June 1, 2020 |
February 19, 2018 |
April 5, 2018 |
|
|
48 |
NCT01413100 |
Recruiting |
Scleroderma Treatment With Autologous Transplant (STAT) Study |
|
- Biological: Anti-Thymocyte Globulin
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Cyclophosphamide
- (and 7 more...)
|
Interventional |
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- EFS of patients undergoing chemotherapy and transplant
- All-cause mortality
- Change in cardiac function
- (and 16 more...)
|
30 |
All |
up to 70 Years (Child, Adult, Senior) |
NCT01413100 |
2533.00 NCI-2011-01190 2533 P30CA015704 |
STAT |
September 15, 2011 |
September 1, 2019 |
|
August 10, 2011 |
January 9, 2018 |
|
- City of Hope Comprehensive Cancer Center
Duarte, California, United States - UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States - University of Colorado
Denver, Colorado, United States - (and 13 more...)
|
49 |
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, Senior) |
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
|
50 |
NCT02682511 |
Recruiting |
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension |
- Scleroderma, Diffuse
- Scleroderma, Systemic
- Scleroderma, Limited
- (and 5 more...)
|
- Drug: Oral Ifetroban
- Drug: Oral Placebo
|
Interventional |
Phase 2 |
- Cumberland Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of adverse events (AEs) and Serious AEs (SAEs)
- Change from baseline in forced vital capacity (FVC)
- Change from baseline in diffusion capacity for carbon monoxide (DLCO)
- Change from baseline in the modified Rodnan skin score (mRSS)
|
34 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02682511 |
CPI-IFE-004 |
|
January 2017 |
December 2018 |
December 2019 |
February 15, 2016 |
January 5, 2018 |
|
- UCLA
Los Angeles, California, United States - Johns Hopkins University
Baltimore, Maryland, United States - Massachusetts General Hospital
Boston, Massachusetts, United States - (and 3 more...)
|