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

Primary Purpose

Systemic Sclerosis, Raynaud Phenomena

Status
Unknown status
Phase
Early Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Methylprednisolone
sodium chloride
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboudumc, Rheumatology departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylprednisolone 1000 mg

sodium chloride

Arm Description

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

The placebo intervention with physiologic salt solution is identical in appearance

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
change in modified Rodnan skin score (mRSS) from baseline
presence of puffy fingers from baseline
presence of synovitis from baseline
presence of tendon friction rubs from baseline
fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline
pulmonary function tests from baseline
presence of interstitial lung disease from baseline
suspicion of pulmonary hypertension from baseline
Change in physical function from baseline
general health score from baseline
Change in 36-Item Short Form Survey (SF-36) total score from baseline
Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline
Change in EQ-5D is a standardised instrument for use as a measure of health outcome. (EQ5D) total score from baseline
Change in gastrointestinal tract ( GIT ) total score from baseline

Full Information

First Posted
January 25, 2017
Last Updated
November 27, 2019
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03059979
Brief Title
The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis, Raynaud Phenomena

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone 1000 mg
Arm Type
Active Comparator
Arm Description
the methylprednisolone is dissolved in 100 cc of sodium chloride (NaCl 0.9%) by intravenous infusion in 30 minutes on three consecutive days
Arm Title
sodium chloride
Arm Type
Placebo Comparator
Arm Description
The placebo intervention with physiologic salt solution is identical in appearance
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Solu-Medrol
Intervention Description
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
Other
Intervention Name(s)
sodium chloride
Other Intervention Name(s)
NaCl 0,9%
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change in capillary density from baseline
Description
presence of enlarged and giant capillaries, hemorrhages, loss of capillaries, disorganization of the micro vascular array, and capillary ramifications.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change in selected biomarkers: the interferon signature in peripheral blood from baseline
Description
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
Time Frame
1 year
Title
change in nail fold capillary changes other than capillary density and giant capillaries from baseline
Description
changes in nail fold capillary pattern (early, active, late, normal
Time Frame
1 year
Title
change in modified Rodnan skin score (mRSS) from baseline
Time Frame
1 year
Title
presence of puffy fingers from baseline
Time Frame
1 year
Title
presence of synovitis from baseline
Time Frame
1 year
Title
presence of tendon friction rubs from baseline
Time Frame
1 year
Title
fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline
Time Frame
1 year
Title
pulmonary function tests from baseline
Time Frame
1 year
Title
presence of interstitial lung disease from baseline
Time Frame
1 year
Title
suspicion of pulmonary hypertension from baseline
Time Frame
1 year
Title
Change in physical function from baseline
Time Frame
1 year
Title
general health score from baseline
Time Frame
1 year
Title
Change in 36-Item Short Form Survey (SF-36) total score from baseline
Time Frame
1 year
Title
Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline
Time Frame
1 year
Title
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
Title
Change in gastrointestinal tract ( GIT ) total score from baseline
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sjoukje Mulder
Phone
+31 24 3619398
Email
sjoukje.mulder@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Brigit Kersten
Phone
+31 24 361 4580
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madelon Vonk, Dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc, Rheumatology department
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sjoukje Mulder
Phone
+31 24 3619398
Email
sjoukje.mulder@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Brigit Kersten
Email
B.Kersten@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Brigit Kersten
First Name & Middle Initial & Last Name & Degree
Madelon Vonk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )

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