NCT04244916

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2021

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

January 6, 2020

Last Update Submit

September 5, 2025

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosisdiffuseinterstitial lung diseasetherapeutic drug monitoring (TDM)mycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Pulmonary efficacy.1

    1 year

  • Pulmonary efficacy.2

    6 months and 1 year

Interventions

AUC of MPA measureBIOLOGICAL

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin hospital, AP-HP

Paris, France, 75014, France

Location

Related Publications (3)

  • 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.

    PMID: 16628123BACKGROUND

  • 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.

    PMID: 20506558BACKGROUND

  • 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.

    PMID: 24304103BACKGROUND

MeSH Terms

Conditions

Scleroderma, SystemicLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 28, 2020

Study Start

May 25, 2020

Primary Completion

August 4, 2021

Study Completion

August 4, 2021

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)