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Clinical trial protocol: PRednisolone in early diffuse cutaneous Systemic Sclerosis (PRedSS).

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This study investigates if moderate-dose prednisolone can safely reduce pain and disability in early diffuse cutaneous systemic sclerosis. The PRedSS trial aims to determine corticosteroid efficacy and safety, particularly for renal function.

Keywords:
Diffuse cutaneous systemic sclerosisdisabilitypainprednisoloneskin score

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Area of Science:

  • Rheumatology
  • Clinical Trials
  • Systemic Sclerosis Research

Background:

  • Early diffuse cutaneous systemic sclerosis presents with inflammatory symptoms like pain, itch, fatigue, and musculoskeletal issues.
  • Corticosteroids may treat these symptoms, but concerns exist regarding their risk of inducing scleroderma renal crisis.
  • The PRedSS trial addresses the clinical dilemma of corticosteroid use in this patient population.

Purpose of the Study:

  • To evaluate the efficacy of moderate-dose prednisolone in reducing pain, disability, and improving skin scores in early diffuse cutaneous systemic sclerosis.
  • To assess the safety of moderate-dose prednisolone, specifically its impact on renal function.
  • To provide evidence-based guidance for clinicians considering corticosteroid therapy in this condition.

Main Methods:

  • A Phase II, multicentre, double-blind, randomised controlled trial (PRedSS) involving 72 patients.
  • Patients will be randomised to receive either prednisolone (approx. 0.3 mg/kg) or placebo for 6 months.
  • Co-primary outcomes include changes in Health Assessment Questionnaire Disability Index and modified Rodnan skin score at 3 months; secondary outcomes assess itch, hand function, and psychological well-being.

Main Results:

  • Recruitment for the PRedSS trial began in December 2017.
  • Despite initial delays, 25 patients have been recruited to date.
  • Full results are pending completion of patient recruitment and follow-up.

Conclusions:

  • The PRedSS trial is designed to clarify whether prednisolone is an appropriate treatment for early diffuse cutaneous systemic sclerosis.
  • Findings will inform clinical decision-making regarding the use of corticosteroids in managing this autoimmune condition.
  • The study aims to balance the potential benefits of symptom relief with the risks of adverse events, particularly renal complications.