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Tiny study on drug monitoring in scleroderma ends early

NCT ID NCT04244916

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study aimed to see if measuring the amount of mycophenolic acid in the blood could help doctors adjust the dose of mycophenolate mofetil (MMF) to better treat skin and lung problems in people with systemic sclerosis. Only 2 patients were enrolled before the study was terminated, so no meaningful results were obtained. The research was exploratory and did not lead to any clear conclusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mycophenolate mofetil (MMF)
What this could lead to
If successful, it could help doctors personalize MMF dosing for better skin and lung outcomes in systemic sclerosis.
What could go wrong
The study was terminated early with only 2 participants, so no reliable conclusions can be drawn. The approach may not improve outcomes in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2 people

The number who actually took part.

Started

May 2020

Finished

Aug 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: \-

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Conditions

The condition(s) this trial relates to.

interstitial lung disease systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic sclerosis

Contacts and locations

Locations

  • Cochin hospital, AP-HP

    Paris, France, 75014, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.