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

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ClinicalTrials.gov Identifier: NCT04244916
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Systemic Sclerosis Biological: AUC of MPA measure

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma


Intervention Details:
  • 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.



Primary Outcome Measures :
  1. Skin efficacy [ Time Frame: 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 Outcome Measures :
  1. Pulmonary efficacy.1 [ Time Frame: 1 year ]
    Modification in FVC

  2. Pulmonary efficacy.2 [ Time Frame: 6 months and 1 year ]
    Modification in DLCO



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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:

    • Failure to take other concomitant immunosuppressive treatments or in the last 3 months except corticosteroid therapy.
    • No treatment with biotherapy in the last 6 months
  • In patients treated for lung damage:

    • No treatment with biotherapy in the last 6 months
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04244916


Contacts
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Contact: Paul LEGENDRE, MD (33) 1.58.41.29.30 paul.legendre@aphp.fr
Contact: Caroline TOURTE (33)1.58.41.11.90 caroline.tourte@aphp.gt

Locations
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France
Cochin hospital, AP-HP Recruiting
Paris, France, 75014
Contact: Paul LEGENDRE, MD    (33) 1.58.41.29.30    paul.legendre@aphp.fr   
Contact: Marie GODARD    (33) 1.58.41.12.11    marie.godard@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04244916    
Other Study ID Numbers: APHP190933
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Systemic sclerosis
diffuse
interstitial lung disease
therapeutic drug monitoring (TDM)
mycophenolate mofetil
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases