Efficacy and safety of repeated Rituximab infusions in patients with Active Systemic SClerosis and background medication, a one year randomized blinded placebo-controlled trial, the RASSc study.
Key facts
- Where
- Leiden, Nijmegen és Utrecht, HollandiaSee the 3 sites
- Phase
- 4. fázis
Where in Hollandia
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaTaking people
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaTaking people
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
- Radboud universitair medisch centrum Stichting
- Trial code
- EU 2025-520483-17-01
- Record updated
- 2025. november 25.
- Original description
The primary objectives of the RASSc study are to examine in patients with early or progressive SSc: 1) The effectiveness of (repeated) RTX compared to placebo in preventing the occurrence of organ involvement and halting progressive diseaseRead full original descriptionShow less
The primary objectives of the RASSc study are to examine in patients with early or progressive SSc: 1) The effectiveness of (repeated) RTX compared to placebo in preventing the occurrence of organ involvement and halting progressive disease
Inclusion: Patients with SSc, with early disease (<4 years) and/or progressive disease, on stable background therapy may be included.
Exclusion: Patients treated with cyclophosphamide iv pulses, tocilizumab or other biologicals currently or in the past 3 months as well as patients treated with autologous hematopoietic stem cell transplantation in the last 2 years will be excluded. Patients with a malignancy or severe pulmonary hypertension (NYHA III and IV) and patients with a contra-indication for RTX such as active moderate or severe infections and severe heart failure will also be excluded.