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

NCT ID: NCT03059979

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2021-07-01

Brief 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. 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

Conditions

Systemic Sclerosis; Raynaud Phenomena

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Methylprednisolone 1000 mg

the methylprednisolone is dissolved in 100 cc of sodium chloride (NaCl 0.9%) by intravenous infusion in 30 minutes on three consecutive days

Group Type: ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type: DRUG

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 chloride

The placebo intervention with physiologic salt solution is identical in appearance

Group Type: PLACEBO_COMPARATOR

sodium chloride

Intervention Type: OTHER

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.

Interventions

Methylprednisolone

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.

Intervention Type: DRUG

sodium chloride

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.

Intervention Type: OTHER

Other Intervention Names

Solu-Medrol; NaCl 0,9%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madelon Vonk, Dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc, Rheumatology department

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Sjoukje Mulder

Role: CONTACT

sjoukje.mulder@radboudumc.nl

+31 24 3619398

Brigit Kersten

Role: CONTACT

+31 24 361 4580

Facility Contacts

Sjoukje Mulder

Role: primary

sjoukje.mulder@radboudumc.nl

+31 24 3619398

Brigit Kersten

Role: backup

B.Kersten@radboudumc.nl

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Other Identifiers

HHaE

Identifier Type: -

Identifier Source: org_study_id