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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04244916

Acronym

SCLERAMAC

Enrollment

Registered

2020-01-28

Start date

2020-05-25

Completion date

2021-08-04

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis, diffuse, interstitial lung disease, therapeutic drug monitoring (TDM), mycophenolate mofetil

Brief 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.

Detailed 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.

Interventions

BIOLOGICALAUC 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Skin efficacy	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).

Secondary

Measure	Time frame	Description
Pulmonary efficacy.1	1 year	Modification in FVC
Pulmonary efficacy.2	6 months and 1 year	Modification in DLCO

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026