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

NCT03059979 | Unknown Early Phase 1 DMC

• 1 other identifier: HHaE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Sclerosis; Raynaud Phenomena

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (16)

• change in selected biomarkers: the interferon signature in peripheral blood from baseline

  1 year

• change in nail fold capillary changes other than capillary density and giant capillaries from baseline

  1 year

• change in modified Rodnan skin score (mRSS) from baseline

  1 year

• presence of puffy fingers from baseline

  1 year

• presence of synovitis from baseline

  1 year

Study Arms (2)

Methylprednisolone 1000 mg

ACTIVE COMPARATOR

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

sodium chloride

PLACEBO COMPARATOR

The placebo intervention with physiologic salt solution is identical in appearance

Other: sodium chloride

Interventions

Methylprednisolone 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.

Also known as: Solu-Medrol

Methylprednisolone 1000 mg

sodium chloride 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.

Also known as: NaCl 0,9%

sodium chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc, Rheumatology department

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate; Sodium Chloride

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Madelon Vonk, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sjoukje Mulder

CONTACT

+31 24 3619398; sjoukje.mulder@radboudumc.nl

Brigit Kersten

CONTACT

+31 24 361 4580

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 23, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 29, 2019

Record last verified: 2019-09

Locations

NL (1)