2025-520483-17-01RecruitingPhase 4
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 3 Apr 2025
- Start date
- 2 Sept 2025
- Lead sponsor
- Radboud universitair medisch centrum Stichting
- Diseases
- Systemic sclerosis (scleroderma)
- EU CT number
- 2025-520483-17-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 105
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- Patients with SSc, with early disease (<4 years) and/or progressive disease, on stable background therapy may be included.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.