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

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 19 February 2024
corticosteroids
cyclophosphamide
immunosuppressive agents
chest x-ray
chest ct
progressive systemic sclerosis
scleroderma
raynaud's phenomenon
raynaud's syndrome
pulmonary involvement
skin sclerosis
raynaud disease
sclerosis skin

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 IdentifierNCT04244916
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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