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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AUC of MPA measure | Biological | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary efficacy.1 | Modification in FVC | 1 year |
| Pulmonary efficacy.2 | Modification in DLCO | 6 months and 1 year |
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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:
In patients treated for lung damage:
Exclusion Criteria:
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Patients receiving MMF for another indication than skin or lung damage to systemic sclerosis (after lung transplantation for example).
Contraindication to MMF: Hypersensitivity to the product. Pregnancy.
In patients treated for skin damage:
In patients treated for lung damage:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin hospital, AP-HP | Paris | France | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16628123 | Background | van Gelder T, Le Meur Y, Shaw LM, Oellerich M, DeNofrio D, Holt C, Holt DW, Kaplan B, Kuypers D, Meiser B, Toenshoff B, Mamelok RD. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit. 2006 Apr;28(2):145-54. doi: 10.1097/01.ftd.0000199358.80013.bd. | |
| 20506558 | Background |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D008171 | Lung Diseases |
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| Zahr N, Arnaud L, Marquet P, Haroche J, Costedoat-Chalumeau N, Hulot JS, Funck-Brentano C, Piette JC, Amoura Z. Mycophenolic acid area under the curve correlates with disease activity in lupus patients treated with mycophenolate mofetil. Arthritis Rheum. 2010 Jul;62(7):2047-54. doi: 10.1002/art.27495. |
| 24304103 | Background | Chaigne B, Gatault P, Darrouzain F, Barbet C, Degenne D, Francois M, Szymanski P, Rabot N, Golea G, Diot E, Maillot F, Lebranchu Y, Nivet H, Paintaud G, Halimi JM, Guillevin L, Buchler M. Mycophenolate mofetil in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis: a prospective pharmacokinetics and clinical study. Clin Exp Immunol. 2014 May;176(2):172-9. doi: 10.1111/cei.12246. |
| D012140 | Respiratory Tract Diseases |