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

November 27, 2019 updated by: Radboud University Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Brigit Kersten
  • Phone Number: +31 24 361 4580

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Recruiting
        • Radboudumc, Rheumatology department
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Brigit Kersten
        • Principal Investigator:
          • Madelon Vonk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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.
Other Names:
  • Solu-Medrol
Placebo Comparator: sodium chloride
The placebo intervention with physiologic salt solution is identical in appearance
Other: 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.
Other Names:
  • NaCl 0,9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in selected biomarkers: the interferon signature in peripheral blood from baseline
Time Frame: 1 year
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
1 year
change in nail fold capillary changes other than capillary density and giant capillaries from baseline
Time Frame: 1 year
changes in nail fold capillary pattern (early, active, late, normal
1 year
change in modified Rodnan skin score (mRSS) from baseline
Time Frame: 1 year
1 year
presence of puffy fingers from baseline
Time Frame: 1 year
1 year
presence of synovitis from baseline
Time Frame: 1 year
1 year
presence of tendon friction rubs from baseline
Time Frame: 1 year
1 year
fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline
Time Frame: 1 year
1 year
pulmonary function tests from baseline
Time Frame: 1 year
1 year
presence of interstitial lung disease from baseline
Time Frame: 1 year
1 year
suspicion of pulmonary hypertension from baseline
Time Frame: 1 year
1 year
Change in physical function from baseline
Time Frame: 1 year
1 year
general health score from baseline
Time Frame: 1 year
1 year
Change in 36-Item Short Form Survey (SF-36) total score from baseline
Time Frame: 1 year
1 year
Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline
Time Frame: 1 year
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
1 year
Change in gastrointestinal tract ( GIT ) total score from baseline
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Madelon Vonk, Dr., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHaE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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