Systemic sclerosis
Conditions
Brief summary
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) 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% and a decline in DLCO ≥ 15%, and/or new ILD on HRCT-scan.
Detailed description
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.
Interventions
DRUGSodium Chloride Fresenius Kabi Italia 0
DRUG9 % Solution for infusion
DRUGMabThera 500 mg concentrate for solution for infusion
Sponsors
Radboud universitair medisch centrum Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 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% and a decline in DLCO ≥ 15%, and/or new ILD on HRCT-scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed