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Study pits two MG drugs Head-to-Head in everyday practice

NCT ID NCT03490539

Knowledge-focused Sponsor: Duke University 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well two drugs, azathioprine and mycophenolate mofetil, work for people with myasthenia gravis in everyday medical practice. Researchers followed 82 adults with autoimmune MG for 2-3 years, measuring quality of life and side effects. The goal was to provide real-world evidence to help patients and doctors choose the best treatment.

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 (Cellcept) and azathioprine (Imuran)
What this could lead to
If successful, this study could help doctors and patients choose between these two drugs based on real-world effectiveness and side effects.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient differences. It is also relatively small (82 participants) and completed, so it provides information but not a definitive answer.

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

82 people

The number who actually took part.

Started

May 2018

Finished

Jan 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

MG patients with autoimmune MG

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: Participants eligible for inclusion in this study must fulfill all of the following criteria: 1. Age ≥ 18 years of age 2. Acquired autoimmune MG, with weakness and confirmed by one or more of the following: 1. Elevated AChR or MuSK antibodies 2. Unequivocal response to cholinesterase inhibitors 3. Abnormal RNS or increased jitter (without nerve or muscle disease sufficient to produce a decrement or increased jitter) 3. Patients seen initially at the participating center after January 1, 2017. 4. Patients on pyridostigmine at the first evaluation at the participating center ("baseline visit") may be included if pyridostigmine was started ≤3 months before the baseline visit. 5. Patients who received corticosteroids \>90 days prior to baseline visit for a non-MG indication may be included. (Patients who have received corticosteroids for a non-MG indication between 31 and 90 days before baseline visit will be evaluated by the primary investigators on a case by case basis to determine if the extent and dose of corticosteroid could have impacted the course of MG or symptoms of MG.) Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible participants. 1. Patients with non-autoimmune MG (congenital myasthenic syndromes, drug-induced MG) 2. Patients on immunosuppressive agents at the baseline visit. 3. Patients who have previously received steroids for the treatment of MG. 4. Patients with steroid use for a non-MG indication \< 30 days prior to the baseline visit. 5. Patients with previous thymectomy, IVIg or plasma exchange, or treatment with a non-steroidal immunosuppressive agent (azathioprine, mycophenolate mofetil cyclosporine, methotrexate, cyclophosphamide, tacrolimus, rituximab, or any investigational immunosuppressive agent). Patients who have outcomes measured within 24 hours after initiation of IVIg or PLEX are acceptable.

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Conditions

The condition(s) this trial relates to.

autoimmune disease myasthenia gravis nervous system disorder

As listed by the trial registrant

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

Autoimmune diseases Neurological disorder

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • London Health Sciences Centre

    London, Ontario, N6A5A5, Canada

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135, United States

  • Stanford University

    Palo Alto, California, 84303, United States

  • University at Buffalo, SUNY

    Buffalo, New York, 14202, United States

  • University of Alberta Hospital, Faculty of Medicine

    Edmonton, Alberta, T6G2G3, Canada

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Vermont - Larner College of Medicine

    Burlington, Vermont, 05401, United States

  • Unversity of Miami

    Miami, Florida, 33136, United States

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