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

BACKGROUND

Many of the painful, disabling features of early diffuse cutaneous systemic sclerosis have an inflammatory component and are potentially treatable with corticosteroid therapy. These features include painful and itchy skin, fatigue and musculoskeletal involvement. Yet many clinicians are understandably reluctant to prescribe corticosteroids because of the concern that these are a risk factor for scleroderma renal crisis. The aim of PRedSS (PRednisolone in early diffuse cutaneous Systemic Sclerosis) is to evaluate the efficacy and safety of moderate dose prednisolone in patients with early diffuse cutaneous systemic sclerosis, specifically whether moderate dose prednisolone is (a) effective in terms of reducing pain and disability, and improving skin score and (b) safe, with particular reference to renal function.

METHODS

PRedSS is a Phase II, multicentre, double-blind randomised controlled trial which aims to recruit 72 patients with early diffuse cutaneous systemic sclerosis. Patients are randomised to receive either prednisolone (dosage approximately 0.3 mg/kg) or placebo therapy for 6 months. The two co-primary outcome measures are the difference in mean Health Assessment Questionnaire Disability Index at 3 months and the difference in modified Rodnan skin score at 3 months. Secondary outcome measures include patient reported outcome measures of itch, hand function, anxiety and depression, and helplessness.

RESULTS

Recruitment commenced in December 2017 and after a slow start (due to delays in opening centres) 25 patients have now been recruited.

CONCLUSION

PRedSS should help to answer the question as to whether clinicians should or should not prescribe prednisolone in early diffuse cutaneous systemic sclerosis.

Informations de copyright

© The Author(s) 2020.

Déclaration de conflit d'intérêts

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: A.L.H. has consultancy relationships with Boehringer-Ingelheim, Gesynta, Camurus and CSL Behring, has received research funding from Actelion and Gesynta, and speaker fees from Actelion. C.P.D. has received research grants from GlaxoSmithKline, CSL Behring, and Inventiva and consulting fees from EMD Serono, Roche, Actelion, GlaxoSmithKline, Sanofi, Inventiva, CSL Behring, Boehringer-Ingelheim, Corbus and Bayer. J.C.M. has received consultancy fees from Roche/Chugai, Novartis, Abbvie and Janssen and speaker fees from Roche/Chugai.