RITUXIMAB for Systemic sclerosis

Inclusion criteria

• {"criterion_text":"- Patients with SSc, with early disease (<4 years) and/or progressive disease, on stable background therapy may be included."}

Exclusion criteria

• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- The primary outcome will be between group differences of disease progression after 12 months follow-up. Disease progression is defined as a dichotomized composite outcome measure representing a clinical relevant worsening in skin and/or lung involvement, defined as: A)\tIncrease in modified Rodnan Skin Score of 3 points and/or 15%, and/or B)\tDecrease ≥ 10% in FVC, or a decrease in FVC ≥ 5%-< 10% and a decline in DLCO ≥ 15%, and/or new ILD on HRCT-scan.","definition_or_measurement_approach":"Disease progression is defined as a dichotomized composite outcome reflecting clinically relevant worsening in skin and/or lung involvement: A) Increase in modified Rodnan Skin Score of 3 points and/or 15%, and/or B) Decrease ≥ 10% in FVC, or a decrease in FVC ≥ 5%-< 10% with a decline in DLCO ≥ 15%, and/or new interstitial lung disease on HRCT-scan. Assessed after 12 months follow-up."}

Secondary endpoints

• {"endpoint_text":"- Secondary outcomes will be assessed during follow-up, after 12 and 18 months. Secondary outcomes include between group differences in other organ involvement, the derived composite outcome CRISS if applicable, changes in nailfold capillaroscopic findings, change in functionality, quality of life, patient satisfaction, mortality, safety and cost-effectiveness with an economic evaluation.","definition_or_measurement_approach":"Assessed at 12 and 18 months; includes incidence/progression of other internal organ involvement (e.g. PAH, renal crisis, GAVE, myositis, arthritis, digital ulcers), derived composite CRISS if applicable, capillary density and nailfold pattern, SHAQ DI v2.0 for functionality, QoL measures (EQ-5D-5L, K-BILD, SF-36, patient and physician global assessment), PSQ-18 for patient satisfaction, cumulative incidence of all-cause and disease-specific mortality, safety (AEs) and cost-effectiveness."}

Netherlands

Earliest CTIS Part Ii Submission Date

20-05-2025

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

189

Number Of Sites

3

Number Of Participants

105

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands