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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-25

Study Completion Date

2021-08-04

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.

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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.

Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type BIOLOGICAL

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.