Systemic SclerosisEarly Phase 1NCT03059979
The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )
A Early Phase 1 study testing Methylprednisolone and sodium chloride in people with Systemic Sclerosis and Raynaud Phenomena, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Raynaud Phenomena
- What is being tested?
- Methylprednisolone and sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to 1 Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age over 18 years
- Fulfilling VEDOSS criteria (9):
- Raynauds' Phenomenon and
- Positive for disease specific auto antibodies (anti-centromere or anti-topoisomerase antibodies) and
- typical nail fold capillaroscopic findings
- Puffy fingers < 3 years
- Modified Rodnan skin score = 0
Who cannot join
- Presence of acroosclerosis, acrosteolysis and digital ulcers
- Presence of anti-RNA polymerase III auto antibodies
- Previous systemic treatment for SSc, namely:
- methotrexate,
- prednisone (> 14 days in previous 6 months),
- mofetil mycophenolate
Show all 20Show fewer
- cyclophosphamide.
- Clinically significant internal organ involvement:
- diffusion capacity of lung for carbon monoxide (DLCO) < 80% predicted,
- vital capacity (VC) < 70% predicted
- renal dysfunction with glomerular filtration rate (GFR) < 60 ml/min
- diastolic dysfunction > grade 1 on echocardiography
- pulmonary hypertension
- weight loss >10% in the last 6 months with unknown cause
- Contra-indications for methylprednisolone, such as:
- pregnancy, lactation
- psychotic or depressive disorder
- ulcus duodeni or ventriculi
- untreated hypertension (> 160-90 mmHg)
- acute infections
Trial locations and contacts
1 site in 1 country.
Brigit Kersten contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc, Rheumatology department
Nijmegen, Gelderland, 6500 HB
Sjoukje Mulder, +31 24 3619398, sjoukje.mulder@radboudumc.nl
Brigit Kersten, B.Kersten@radboudumc.nl
About this study
Official title: Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.
This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline
Read the detailed description
Systemic sclerosis is a disease with a high burden caused by morbidity and increased mortality. To date a cure for SSc is not available. In this trial, patients are treated very early in the disease which could change the long term outcome of SSc in these patients.
In daily practice, patients so early in the disease course are not treated although they might be at risk for early escalation and internal organ involvement, reducing their prognosis. A trial to investigate the efficacy of a relative save, inexpensive and easy accessible treatment will provide us with the opportunity to change the disease course and reducing the disease burden of a portion of the SSc patients
- Conditions
- Systemic Sclerosis, Raynaud Phenomena
- Being tested
- Methylprednisolone, sodium chloride
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solu-Medrol
methylprednisolone 1000 mg dissolved in 100 cc of NaCl 0.9%, by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.
sodium chlorideOther
Also called NaCl 0,9%
100 cc of NaCl 0,9% , administered by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone 1000 mg | Active comparator | the methylprednisolone is dissolved in 100 cc of sodium chloride (NaCl 0.9%) by intravenous infusion in 30 minutes on three consecutive days Receives: Drug: Methylprednisolone |
| sodium chloride | Placebo comparator | The placebo intervention with physiologic salt solution is identical in appearance Receives: Other: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in capillary density from baseline
presence of enlarged and giant capillaries, hemorrhages, loss of capillaries, disorganization of the micro vascular array, and capillary ramifications.
Measured: 12 weeks
Secondary outcomes (16)
change in selected biomarkers: the interferon signature in peripheral blood from baseline
Plasma biomarkers consist soluble inflammatory mediators platelet factor 4, interleukin-1β, interleukin-6, tumor necrosis factor-α, endothelin-1, intercellular adhesion molecule-1 and vascular endothelial growth factor
Measured: 1 year
change in nail fold capillary changes other than capillary density and giant capillaries from baseline
changes in nail fold capillary pattern (early, active, late, normal
Measured: 1 year
change in modified Rodnan skin score (mRSS) from baseline
Measured: 1 year
presence of puffy fingers from baseline
Measured: 1 year
presence of synovitis from baseline
Measured: 1 year
presence of tendon friction rubs from baseline
Measured: 1 year
fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline
Measured: 1 year
pulmonary function tests from baseline
Measured: 1 year
presence of interstitial lung disease from baseline
Measured: 1 year
suspicion of pulmonary hypertension from baseline
Measured: 1 year
Change in physical function from baseline
Measured: 1 year
general health score from baseline
Measured: 1 year
Change in 36-Item Short Form Survey (SF-36) total score from baseline
Measured: 1 year
Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline
Measured: 1 year
Change in EQ-5D is a standardised instrument for use as a measure of health outcome. (EQ5D) total score from baseline
Measured: 1 year
Change in gastrointestinal tract ( GIT ) total score from baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJan 2017
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madelon Vonk, Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059979
- Sponsor's protocol ID
- HHaE
- Status last verified
- Sep 2019
- First submitted
- 25 Jan 2017
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Geyer M, Muller-Ladner U. The pathogenesis of systemic sclerosis revisited. Clin Rev Allergy Immunol. 2011 Apr;40(2):92-103. doi: 10.1007/s12016-009-8193-3.
PubMed 20087791van Bon L, Affandi AJ, Broen J, Christmann RB, Marijnissen RJ, Stawski L, Farina GA, Stifano G, Mathes AL, Cossu M, York M, Collins C, Wenink M, Huijbens R, Hesselstrand R, Saxne T, DiMarzio M, Wuttge D, Agarwal SK, Reveille JD, Assassi S, Mayes M, Deng Y, Drenth JP, de Graaf J, den Heijer M, Kallenberg CG, Bijl M, Loof A, van den Berg WB, Joosten LA, Smith V, de Keyser F, Scorza R, Lunardi C, van Riel PL, Vonk M, van Heerde W, Meller S, Homey B, Beretta L, Roest M, Trojanowska M, Lafyatis R, Radstake TR. Proteome-wide analysis and CXCL4 as a biomarker in systemic sclerosis. N Engl J Med. 2014 Jan 30;370(5):433-43. doi: 10.1056/NEJMoa1114576. Epub 2013 Dec 18.
PubMed 24350901Radstake TR, Gorlova O, Rueda B, Martin JE, Alizadeh BZ, Palomino-Morales R, Coenen MJ, Vonk MC, Voskuyl AE, Schuerwegh AJ, Broen JC, van Riel PL, van 't Slot R, Italiaander A, Ophoff RA, Riemekasten G, Hunzelmann N, Simeon CP, Ortego-Centeno N, Gonzalez-Gay MA, Gonzalez-Escribano MF; Spanish Scleroderma Group; Airo P, van Laar J, Herrick A, Worthington J, Hesselstrand R, Smith V, de Keyser F, Houssiau F, Chee MM, Madhok R, Shiels P, Westhovens R, Kreuter A, Kiener H, de Baere E, Witte T, Padykov L, Klareskog L, Beretta L, Scorza R, Lie BA, Hoffmann-Vold AM, Carreira P, Varga J, Hinchcliff M, Gregersen PK, Lee AT, Ying J, Han Y, Weng SF, Amos CI, Wigley FM, Hummers L, Nelson JL, Agarwal SK, Assassi S, Gourh P, Tan FK, Koeleman BP, Arnett FC, Martin J, Mayes MD. Genome-wide association study of systemic sclerosis identifies CD247 as a new susceptibility locus. Nat Genet. 2010 May;42(5):426-9. doi: 10.1038/ng.565. Epub 2010 Apr 11.
PubMed 20383147Greenblatt MB, Aliprantis AO. The immune pathogenesis of scleroderma: context is everything. Curr Rheumatol Rep. 2013 Jan;15(1):297. doi: 10.1007/s11926-012-0297-8.
PubMed 23288576Tyndall AJ, Bannert B, Vonk M, Airo P, Cozzi F, Carreira PE, Bancel DF, Allanore Y, Muller-Ladner U, Distler O, Iannone F, Pellerito R, Pileckyte M, Miniati I, Ananieva L, Gurman AB, Damjanov N, Mueller A, Valentini G, Riemekasten G, Tikly M, Hummers L, Henriques MJ, Caramaschi P, Scheja A, Rozman B, Ton E, Kumanovics G, Coleiro B, Feierl E, Szucs G, Von Muhlen CA, Riccieri V, Novak S, Chizzolini C, Kotulska A, Denton C, Coelho PC, Kotter I, Simsek I, de la Pena Lefebvre PG, Hachulla E, Seibold JR, Rednic S, Stork J, Morovic-Vergles J, Walker UA. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis. 2010 Oct;69(10):1809-15. doi: 10.1136/ard.2009.114264. Epub 2010 Jun 15.
PubMed 20551155Kowal-Bielecka O, Landewe R, Avouac J, Chwiesko S, Miniati I, Czirjak L, Clements P, Denton C, Farge D, Fligelstone K, Foldvari I, Furst DE, Muller-Ladner U, Seibold J, Silver RM, Takehara K, Toth BG, Tyndall A, Valentini G, van den Hoogen F, Wigley F, Zulian F, Matucci-Cerinic M; EUSTAR Co-Authors. EULAR recommendations for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group (EUSTAR). Ann Rheum Dis. 2009 May;68(5):620-8. doi: 10.1136/ard.2008.096677. Epub 2009 Jan 15.
PubMed 19147617van Laar JM, Farge D, Sont JK, Naraghi K, Marjanovic Z, Larghero J, Schuerwegh AJ, Marijt EW, Vonk MC, Schattenberg AV, Matucci-Cerinic M, Voskuyl AE, van de Loosdrecht AA, Daikeler T, Kotter I, Schmalzing M, Martin T, Lioure B, Weiner SM, Kreuter A, Deligny C, Durand JM, Emery P, Machold KP, Sarrot-Reynauld F, Warnatz K, Adoue DF, Constans J, Tony HP, Del Papa N, Fassas A, Himsel A, Launay D, Lo Monaco A, Philippe P, Quere I, Rich E, Westhovens R, Griffiths B, Saccardi R, van den Hoogen FH, Fibbe WE, Socie G, Gratwohl A, Tyndall A; EBMT/EULAR Scleroderma Study Group. Autologous hematopoietic stem cell transplantation vs intravenous pulse cyclophosphamide in diffuse cutaneous systemic sclerosis: a randomized clinical trial. JAMA. 2014 Jun 25;311(24):2490-8. doi: 10.1001/jama.2014.6368.
PubMed 25058083Czirjak L, Matucci-Cerinic M. Beyond Raynaud's phenomenon hides very early systemic sclerosis: the assessment of organ involvement is always mandatory. Rheumatology (Oxford). 2011 Feb;50(2):250-1. doi: 10.1093/rheumatology/keq374. Epub 2010 Nov 28. No abstract available.
PubMed 21115465Minier T, Guiducci S, Bellando-Randone S, Bruni C, Lepri G, Czirjak L, Distler O, Walker UA, Fransen J, Allanore Y, Denton C, Cutolo M, Tyndall A, Muller-Ladner U, Matucci-Cerinic M; EUSTAR co-workers; EUSTAR co-workers. Preliminary analysis of the very early diagnosis of systemic sclerosis (VEDOSS) EUSTAR multicentre study: evidence for puffy fingers as a pivotal sign for suspicion of systemic sclerosis. Ann Rheum Dis. 2014 Dec;73(12):2087-93. doi: 10.1136/annrheumdis-2013-203716. Epub 2013 Aug 12.
PubMed 23940211Hahn BH, Kantor OS, Osterland CK. Azathioprine plus prednisone compared with prednisone alone in the treatment of systemic lupus erythematosus. Report of a prospective controlled trial in 24 patients. Ann Intern Med. 1975 Nov;83(5):597-605. doi: 10.7326/0003-4819-83-5-597.
PubMed 1106277Marie I, Mouthon L. Therapy of polymyositis and dermatomyositis. Autoimmun Rev. 2011 Nov;11(1):6-13. doi: 10.1016/j.autrev.2011.06.007. Epub 2011 Jun 28.
PubMed 21740984Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
PubMed 16236742Iudici M, van der Goes MC, Valentini G, Bijlsma JW. Glucocorticoids in systemic sclerosis: weighing the benefits and risks - a systematic review. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):157-65. Epub 2013 Jul 23.
PubMed 23910618Matucci-Cerinic M, Bellando-Randone S, Lepri G, Bruni C, Guiducci S. Very early versus early disease: the evolving definition of the 'many faces' of systemic sclerosis. Ann Rheum Dis. 2013 Mar;72(3):319-21. doi: 10.1136/annrheumdis-2012-202295. Epub 2012 Nov 23. No abstract available.
PubMed 23178210Auphan N, DiDonato JA, Rosette C, Helmberg A, Karin M. Immunosuppression by glucocorticoids: inhibition of NF-kappa B activity through induction of I kappa B synthesis. Science. 1995 Oct 13;270(5234):286-90. doi: 10.1126/science.270.5234.286.
PubMed 7569976
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT03059979
- Acronym / sponsor ID
- HHaE
- Conditions
- Systemic Sclerosis, Raynaud Phenomena
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline
Detailed description
Systemic sclerosis is a disease with a high burden caused by morbidity and increased mortality. To date a cure for SSc is not available. In this trial, patients are treated very early in the disease which could change the long term outcome of SSc in these patients.
In daily practice, patients so early in the disease course are not treated although they might be at risk for early escalation and internal organ involvement, reducing their prognosis. A trial to investigate the efficacy of a relative save, inexpensive and easy accessible treatment will provide us with the opportunity to change the disease course and reducing the disease burden of a portion of the SSc patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone 1000 mg | Active comparator | Drug: Methylprednisolonethe methylprednisolone is dissolved in 100 cc of sodium chloride (NaCl 0.9%) by intravenous infusion in 30 minutes on three consecutive days |
| sodium chloride | Placebo comparator | Other: sodium chlorideThe placebo intervention with physiologic salt solution is identical in appearance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Age over 18 years
- Fulfilling VEDOSS criteria (9):
- Puffy fingers < 3 years
- Modified Rodnan skin score = 0
Key exclusion criteria (20 listed)
- Presence of acroosclerosis, acrosteolysis and digital ulcers
- Presence of anti-RNA polymerase III auto antibodies
- methotrexate,
- prednisone (> 14 days in previous 6 months),
- mofetil mycophenolate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneAlso: Solu-Medrolmethylprednisolone 1000 mg dissolved in 100 cc of NaCl 0.9%, by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8. | Drug | Methylprednisolone 1000 mg |
| sodium chlorideAlso: NaCl 0,9%100 cc of NaCl 0,9% , administered by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8. | Other | sodium chloride |
Primary outcome
the change in capillary density from baseline
Time frame: 12 weeks
presence of enlarged and giant capillaries, hemorrhages, loss of capillaries, disorganization of the micro vascular array, and capillary ramifications.
16 secondary outcomes
change in selected biomarkers: the interferon signature in peripheral blood from baseline
Time frame: 1 year
change in nail fold capillary changes other than capillary density and giant capillaries from baseline
Time frame: 1 year
change in modified Rodnan skin score (mRSS) from baseline
Time frame: 1 year
presence of puffy fingers from baseline
Time frame: 1 year
presence of synovitis from baseline
Time frame: 1 year
presence of tendon friction rubs from baseline
Time frame: 1 year
fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline
Time frame: 1 year
pulmonary function tests from baseline
Time frame: 1 year
presence of interstitial lung disease from baseline
Time frame: 1 year
suspicion of pulmonary hypertension from baseline
Time frame: 1 year
Change in physical function from baseline
Time frame: 1 year
general health score from baseline
Time frame: 1 year
Change in 36-Item Short Form Survey (SF-36) total score from baseline
Time frame: 1 year
Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline
Time frame: 1 year
Change in EQ-5D is a standardised instrument for use as a measure of health outcome. (EQ5D) total score from baseline
Time frame: 1 year
Change in gastrointestinal tract ( GIT ) total score from baseline
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Background: PubMed 20087791Geyer M, Muller-Ladner U. The pathogenesis of systemic sclerosis revisited. Clin Rev Allergy Immunol. 2011 Apr;40(2):92-103. doi: 10.1007/s12016-009-8193-3.
- Background: PubMed 24350901van Bon L, Affandi AJ, Broen J, Christmann RB, Marijnissen RJ, Stawski L, Farina GA, Stifano G, Mathes AL, Cossu M, York M, Collins C, Wenink M, Huijbens R, Hesselstrand R, Saxne T, DiMarzio M, Wuttge D, Agarwal SK, Reveille JD, Assassi S, Mayes M, Deng Y, Drenth JP, de Graaf J, den Heijer M, Kallenberg CG, Bijl M, Loof A, van den Berg WB, Joosten LA, Smith V, de Keyser F, Scorza R, Lunardi C, van Riel PL, Vonk M, van Heerde W, Meller S, Homey B, Beretta L, Roest M, Trojanowska M, Lafyatis R, Radstake TR. Proteome-wide analysis and CXCL4 as a biomarker in systemic sclerosis. N Engl J Med. 2014 Jan 30;370(5):433-43. doi: 10.1056/NEJMoa1114576. Epub 2013 Dec 18.
- Background: PubMed 20383147Radstake TR, Gorlova O, Rueda B, Martin JE, Alizadeh BZ, Palomino-Morales R, Coenen MJ, Vonk MC, Voskuyl AE, Schuerwegh AJ, Broen JC, van Riel PL, van 't Slot R, Italiaander A, Ophoff RA, Riemekasten G, Hunzelmann N, Simeon CP, Ortego-Centeno N, Gonzalez-Gay MA, Gonzalez-Escribano MF; Spanish Scleroderma Group; Airo P, van Laar J, Herrick A, Worthington J, Hesselstrand R, Smith V, de Keyser F, Houssiau F, Chee MM, Madhok R, Shiels P, Westhovens R, Kreuter A, Kiener H, de Baere E, Witte T, Padykov L, Klareskog L, Beretta L, Scorza R, Lie BA, Hoffmann-Vold AM, Carreira P, Varga J, Hinchcliff M, Gregersen PK, Lee AT, Ying J, Han Y, Weng SF, Amos CI, Wigley FM, Hummers L, Nelson JL, Agarwal SK, Assassi S, Gourh P, Tan FK, Koeleman BP, Arnett FC, Martin J, Mayes MD. Genome-wide association study of systemic sclerosis identifies CD247 as a new susceptibility locus. Nat Genet. 2010 May;42(5):426-9. doi: 10.1038/ng.565. Epub 2010 Apr 11.
- Background: PubMed 23288576Greenblatt MB, Aliprantis AO. The immune pathogenesis of scleroderma: context is everything. Curr Rheumatol Rep. 2013 Jan;15(1):297. doi: 10.1007/s11926-012-0297-8.
- Background: PubMed 20551155Tyndall AJ, Bannert B, Vonk M, Airo P, Cozzi F, Carreira PE, Bancel DF, Allanore Y, Muller-Ladner U, Distler O, Iannone F, Pellerito R, Pileckyte M, Miniati I, Ananieva L, Gurman AB, Damjanov N, Mueller A, Valentini G, Riemekasten G, Tikly M, Hummers L, Henriques MJ, Caramaschi P, Scheja A, Rozman B, Ton E, Kumanovics G, Coleiro B, Feierl E, Szucs G, Von Muhlen CA, Riccieri V, Novak S, Chizzolini C, Kotulska A, Denton C, Coelho PC, Kotter I, Simsek I, de la Pena Lefebvre PG, Hachulla E, Seibold JR, Rednic S, Stork J, Morovic-Vergles J, Walker UA. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis. 2010 Oct;69(10):1809-15. doi: 10.1136/ard.2009.114264. Epub 2010 Jun 15.
- Background: PubMed 19147617Kowal-Bielecka O, Landewe R, Avouac J, Chwiesko S, Miniati I, Czirjak L, Clements P, Denton C, Farge D, Fligelstone K, Foldvari I, Furst DE, Muller-Ladner U, Seibold J, Silver RM, Takehara K, Toth BG, Tyndall A, Valentini G, van den Hoogen F, Wigley F, Zulian F, Matucci-Cerinic M; EUSTAR Co-Authors. EULAR recommendations for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group (EUSTAR). Ann Rheum Dis. 2009 May;68(5):620-8. doi: 10.1136/ard.2008.096677. Epub 2009 Jan 15.
- Background: PubMed 25058083van Laar JM, Farge D, Sont JK, Naraghi K, Marjanovic Z, Larghero J, Schuerwegh AJ, Marijt EW, Vonk MC, Schattenberg AV, Matucci-Cerinic M, Voskuyl AE, van de Loosdrecht AA, Daikeler T, Kotter I, Schmalzing M, Martin T, Lioure B, Weiner SM, Kreuter A, Deligny C, Durand JM, Emery P, Machold KP, Sarrot-Reynauld F, Warnatz K, Adoue DF, Constans J, Tony HP, Del Papa N, Fassas A, Himsel A, Launay D, Lo Monaco A, Philippe P, Quere I, Rich E, Westhovens R, Griffiths B, Saccardi R, van den Hoogen FH, Fibbe WE, Socie G, Gratwohl A, Tyndall A; EBMT/EULAR Scleroderma Study Group. Autologous hematopoietic stem cell transplantation vs intravenous pulse cyclophosphamide in diffuse cutaneous systemic sclerosis: a randomized clinical trial. JAMA. 2014 Jun 25;311(24):2490-8. doi: 10.1001/jama.2014.6368.
- Background: PubMed 21115465Czirjak L, Matucci-Cerinic M. Beyond Raynaud's phenomenon hides very early systemic sclerosis: the assessment of organ involvement is always mandatory. Rheumatology (Oxford). 2011 Feb;50(2):250-1. doi: 10.1093/rheumatology/keq374. Epub 2010 Nov 28. No abstract available.
- Background: PubMed 23940211Minier T, Guiducci S, Bellando-Randone S, Bruni C, Lepri G, Czirjak L, Distler O, Walker UA, Fransen J, Allanore Y, Denton C, Cutolo M, Tyndall A, Muller-Ladner U, Matucci-Cerinic M; EUSTAR co-workers; EUSTAR co-workers. Preliminary analysis of the very early diagnosis of systemic sclerosis (VEDOSS) EUSTAR multicentre study: evidence for puffy fingers as a pivotal sign for suspicion of systemic sclerosis. Ann Rheum Dis. 2014 Dec;73(12):2087-93. doi: 10.1136/annrheumdis-2013-203716. Epub 2013 Aug 12.
- Background: PubMed 1106277Hahn BH, Kantor OS, Osterland CK. Azathioprine plus prednisone compared with prednisone alone in the treatment of systemic lupus erythematosus. Report of a prospective controlled trial in 24 patients. Ann Intern Med. 1975 Nov;83(5):597-605. doi: 10.7326/0003-4819-83-5-597.
- Background: PubMed 21740984Marie I, Mouthon L. Therapy of polymyositis and dermatomyositis. Autoimmun Rev. 2011 Nov;11(1):6-13. doi: 10.1016/j.autrev.2011.06.007. Epub 2011 Jun 28.
- Background: PubMed 16236742Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigit Kersten contact
Madelon Vonk, Dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methylprednisolone and sodium chloride in people with Systemic Sclerosis and Raynaud Phenomena, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sjoukje Mulder (+31 24 3619398, sjoukje.mulder@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in capillary density from baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059979, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.