TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE VERSUS PLACEBO IN EARLY SYSTEMIC SCLEROSIS (SSc)
Key facts
- Where
- Rome, OlaszországSee the 2 sites
- Phase
- 3. fázis
Where in Olaszország
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Trial code
- EU 2024-516050-22-00
- Record updated
- 2025. január 20.
- Original description
To evaluate the efficacy and safety of hydroxychloroquine compared to placebo, at the oral dose of 6 mg/kg daily (up to 400 mg/day), in the treatment of early systemic sclerosis (SSc) associated to SSc standard therapies (immunosuppressive and/or vasoactive).Read full original descriptionShow less
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADD-ON TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE IN EARLY SYSTEMIC SCLEROSIS (SSc)- HYDROXYSSc
To evaluate the efficacy and safety of hydroxychloroquine compared to placebo, at the oral dose of 6 mg/kg daily (up to 400 mg/day), in the treatment of early systemic sclerosis (SSc) associated to SSc standard therapies (immunosuppressive and/or vasoactive).
Inclusion: Diagnosis of SSc according 2013 ACR/EULAR criteria for classification of SSc (van den Hoogen et al, 2013); Written Informed Consent (IC)(patient must be able and agree to sign an IC according ICH-GCP guidelines and local laws); Age >= 18 years; Disease duration <= 5 years from the first non-Raynaud’s symptom; Stable SSc standard treatment within 4 weeks prior to Screening visit; Subjects naïve to treatment with hydroxychloroquine or who have undergone a wash-out period of at least 16 weeks (approximately 3 half-lives of the drug).
Exclusion: Known hypersensytivity to the study drug (active substance or excipients) or derivatives 4-aminoquinolines; Anticoagulant and/or antiplatelet therapy; History of retynopathy and/or maculopathy; History of severe miopathy (other than SSc related); History of periferic neuropathy; History of hypoglycemia; History of bradycardia (HR<50) or ventricular arrhythmias; Deficiency of glucose-6-phosphate dehydrogenase; Other contraindicated clinical and / or laboratory conditions; Age < 18 years; Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1; Pregnant or breast feeding women; Body weight < 45 kg.