What is the Optimal Follow-up for Patients With Systemic Sclerosis?

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Nov 1, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the best way to follow up with patients who have systemic sclerosis (SSc), a complex autoimmune disease that affects various parts of the body. Currently, there are no clear guidelines on how often these patients should be monitored or how thorough those check-ups should be. The study is based on a care pathway called the "Leiden Combined Care in SSc (CCISS pathway)," which has been helping patients since 2009. Researchers have found that about half of the patients experience mild disease without it getting worse over time. This means that some patients may not need as frequent or intensive care. To help personalize treatment, the study has developed a model to identify patients who are at low risk for disease progression.

To participate in this trial, patients need to be at least 18 years old, have a clinical diagnosis of SSc, and have been part of specific cohorts (groups of patients) with at least two evaluations in the care pathway. They must also be considered low or intermediate risk for disease progression according to the prediction model. Participants will receive tailored care based on their individual disease activity and will help researchers better understand how to manage SSc effectively. It's important to note that patients currently involved in other clinical trials or those who are categorized as high risk for disease progression will not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participation in the prospective Haga, HMC or LUMC cohort
• • 2. Clinical diagnosis of SSc
• • 3. Age of ≥18 years
• • 4. \>= two evaluations in the Care Pathway
• • 5. Low or intermediate risk for disease progression according to the prediction model
• • 6. Written informed consent
• Exclusion Criteria:
• • 1. Patients with SSc who are part of ongoing (randomized) trials
• • 2. Patients who have had an autologous stem cell transplantation in the past five years
• • 3. Patients with SSc who were categorized as high risk for disease progression according to the prediction model.