MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Biological: AUC of MPA measure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemic sclerosis meeting the ACR / EULAR criteria of 2013 Equal or more than 18 years old, able to freely consent to study In patients treated for skin damage: Diffuse skin sclerosis (rising above the elbows and / or knees) First clinical sign of systemic sclerosis outside of Raynaud's phenomenon going back less than three years Failure to take other concomitant immunosuppressive treatments or in the last 3 months except corticosteroids. In patients treated for lung damage: Interstitial lung damage identified on chest CT, chest x-ray Any duration of progression of systemic scleroderma Prescription of MMF in first line or in relay of a treatment with Cyclophosphamide. Absence of biotherapy in the last 6 months. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin efficacy | 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). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary efficacy.1 | Modification in FVC | 1 year | 
| Pulmonary efficacy.2 | Modification in DLCO | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic sclerosis, diffuse, interstitial lung disease, therapeutic drug monitoring (TDM), mycophenolate mofetil