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Taking people in NetherlandsPhase 4

Tests repeated rituximab infusions against placebo in systemic sclerosis

Tests whether repeated rituximab infusions help adults with early or worsening systemic sclerosis.

Key facts

Who runs it
Radboud universitair medisch centrum Stichting
Where
Leiden, Nijmegen, and Utrecht, NetherlandsSee the 3 sites
Registry title
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.
Status
Recruiting
Phase
Phase 4
People taking part
105 people, planned
Started
2 Sept 2025
Expected to end
1 Mar 2027
Type of study
Interventional
Record updated
25 November 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with systemic sclerosis (SSc) that is early (under 4 years) or getting worse, who are on a stable background treatment.

Age
18 years or older
Sex
Men and women
Disease stage
Early disease (under 4 years) and/or progressive disease
Earlier treatment
Must be on stable background therapy. Cannot have had cyclophosphamide iv pulses, tocilizumab or other biologicals now or in the past 3 months, or autologous hematopoietic stem cell transplantation in the last 2 years.

Main reasons for not taking part

  • Cyclophosphamide iv pulses, tocilizumab or other biologicals now or in the past 3 months
  • Autologous hematopoietic stem cell transplantation in the last 2 years
  • A malignancy
  • Severe pulmonary hypertension (NYHA III and IV)
  • A contra-indication for RTX, such as active moderate or severe infection or severe heart failure

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Patients with SSc, with early disease (<4 years) and/or progressive disease, on stable background therapy may be included

Who cannot take part

  • 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

Where in Netherlands

  • Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
  • Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people
  • Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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.
Plain-language title
Tests repeated rituximab infusions against placebo in systemic sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
25 November 2025