MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic Sclerosis
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- STATUS
- Recruiting
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- participants needed
- 50
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- sponsor
- Assistance Publique - Hôpitaux de Paris
Summary
To define a target value of AUC MPA to improve the modified Rodnan score and / or respiratory impairment (DLCO or FVC) at one year in patients receiving MMF for the treatment of diffuse cutaneous or interstitial lung damage of systemic sclerosis.
Description
In the treatment of autoimmune diseases, MMF is almost always prescribed at a fixed dose, regardless of AUC, or based on the target of AUC determined for organ transplantation. One study looked at determining an "effective" AUC threshold in systemic lupus erythematosus, which appears to be 35mg / h / l. This was also done for ANCA vasculitis.
We therefore conducted this study to determine a correlation between AUC MPA and the effectiveness of MMF in systemic sclerosis.
Prospective, observational, open study.
Main objective: define a target value of AUC MPA to improve the modified Rodnan score and / or respiratory impairment (DLCO or FVC) at one year in patients receiving MMF for the treatment of diffuse skin involvement or pulmonary function in systemic sclerosis.
The main endpoint will be evaluated on the evolution of the modified Rodnan score at 1 year after the initiation of MMF and / or the evolution of FVC and DLCO at 1 year after the initiation of MMF.
Details
| Condition | CONNECTIVE TISSUE DISEASE, Scleroderma, Systemic sclerosis, Scleroderma, Dermatosis |
|---|---|
| Age | 18years - 100years |
| Treatment | AUC of MPA measure |
| Clinical Study Identifier | NCT04244916 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Last Modified on | 19 February 2024 |
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