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NCT05878717
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
NCT06105073
Interstitial Lung Disease associated with Systemic Sclerosis currently represents the main cause of death in this disease, it is also the cause of significant morbidity, which is why pulmonary rehabilitation strategies can be of great benefit in this group of patients. The aim of this study is to determine the effect of a 36-session supervised pulmonary rehabilitation program compared before and after, on oxygen consumption, functionality, and quality of life in Interstitial Lung The main question it aims to answer are: What effect will have with a 36-session supervised pulmonary rehabilitation program, compared before and after, on oxygen consumption, functionality and quality of life in Interstitial Lung Disease associated with Systemic Sclerosis, estimated by Cardiopulmonary Exercise Test, the questionnaire self-administered SySQ (systemic sclerosis functionality questionnaire) and the self-administered questionnaire SF-36. Disease associated with Systemic Sclerosis. Study design: Quasi-experimental, longitudinal, comparative before and after study. Methods: Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Systemic Sclerosis, at the Speciality Hospital of the National Medical Center La raza IMSS (Mexican Institute of Social Security), all those patients who wish to participate in the study will be asked to sign the informed consent letter, subsequently the Goldberg anxiety and depression questionnaire will be applied, as well as the SF-36 questionnaire to evaluate quality of life and SySQ to evaluate functionality, all participants will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test, the Pulmonary Function laboratory of the General Hospital National Medical Center La Raza IMSS . Subsequently, they will be sent to the Pulmonary Rehabilitation service, where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions (12 weeks). After the end of the program, respiratory function tests and tests will be performed again questionnaires, pulmonary function tests and cardiopulmonary exercise test.