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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03059979
Date of registration: 25/01/2017
Prospective Registration: Yes
Primary sponsor: Radboud University
Public title: The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )
Scientific 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.
Date of first enrolment: January 2017
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03059979
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Early Phase 1
Countries of recruitment
Netherlands
Contacts
Name:     Sjoukje Mulder
Address: 
Telephone: +31 24 3619398
Email: sjoukje.mulder@radboudumc.nl
Affiliation: 
Name:     Sjoukje Mulder
Address: 
Telephone: +31 24 3619398
Email: sjoukje.mulder@radboudumc.nl
Affiliation: 
Name:     Madelon Vonk, Dr.
Address: 
Telephone:
Email:
Affiliation:  Radboud University
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Raynaud Phenomena
Systemic Sclerosis
Intervention(s)
Drug: Methylprednisolone
Other: sodium chloride
Primary Outcome(s)
the change in capillary density from baseline [Time Frame: 12 weeks]
Secondary Outcome(s)
Change in 36-Item Short Form Survey (SF-36) 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]
change in modified Rodnan skin score (mRSS) 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 physical function from baseline [Time Frame: 1 year]
Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline [Time Frame: 1 year]
change in selected biomarkers: the interferon signature in peripheral blood 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]
general health score from baseline [Time Frame: 1 year]
presence of interstitial lung disease 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]
pulmonary function tests from baseline [Time Frame: 1 year]
suspicion of pulmonary hypertension from baseline [Time Frame: 1 year]
Secondary ID(s)
HHaE
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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