The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03059979
• Date of registration: 25/01/2017
• Prospective Registration: No
• 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

• Name: Madelon Vonk, Dr.
• Affiliation: Radboud University

• Name: Sjoukje Mulder

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)

pulmonary function tests from baseline [Time Frame: 1 year]

presence of tendon friction rubs from baseline [Time Frame: 1 year]

Change in gastrointestinal tract ( GIT ) total score 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 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]

suspicion of pulmonary hypertension from baseline [Time Frame: 1 year]

change in selected biomarkers: the interferon signature in peripheral blood from baseline [Time Frame: 1 year]

presence of interstitial lung disease from baseline [Time Frame: 1 year]

Change in physical function 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]

general health score from baseline [Time Frame: 1 year]

change in modified Rodnan skin score (mRSS) from baseline [Time Frame: 1 year]

Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score 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]

Secondary ID(s)

HHaE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors