MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic Sclerosis (SCLERAMAC)
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|ClinicalTrials.gov Identifier: NCT04244916|
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment|
|Systemic Sclerosis||Biological: AUC of MPA measure|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Prospective Study to Investigate the Relevance of Monitoring Area Under the Curve of Mycophenolic Acid in Patients Receiving Mycophenolate Mofetil to Treat a Diffuse Cutaneous or a Pulmonary Involvement of Systemic Sclerosis|
|Actual Study Start Date :||May 25, 2020|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||September 1, 2023|
- Biological: AUC of MPA measure
Plasmatic AUC determination of MPA requires 3 blood punctures at H0, H30 and H2.
These punctures will be made at inclusion after 6 weeks, 12 weeks, 6 months and one year.
- Skin efficacy [ Time Frame: 1 year ]Modified Rodnan skin score (mRSS) : min 0 max 51. A diminution in the mRSS of more than 25% from the initial value was considered as improved. On the contrary, an increase in the mRSS over 25% was considered as deteriorated. All other variations of mRSS were classified as stable. Minimal clinically important difference was also tested (worsening of mRSS ≥ 4.7).
- Pulmonary efficacy.1 [ Time Frame: 1 year ]Modification in FVC
- Pulmonary efficacy.2 [ Time Frame: 6 months and 1 year ]Modification in DLCO
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04244916
|Contact: Paul LEGENDRE, MD||(33) firstname.lastname@example.org|
|Contact: Caroline TOURTE||(33)email@example.com|