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Tests treatment safety and results for Myasthenia Gravis, Generalized
Official title Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)
ClinicalTrials.gov ID: NCT05868837
What this study is testing
What is Rituximab?
Rituximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myasthenia gravis, generalized.
Also referred to as MabThera, Rituxan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this phase III trial is to investigate if Rituximab can reduce patients' functional impairment caused by MG. The secondary objectives of this trial are to assess whether treatment with rituximab in patients with MG will: Allow faster and greater corticosteroid tapering Reduce the frequency of exacerbations Improve quality of life Offer an acceptable safety and tolerability profile.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- a. Positive serologic test for anti-AChR or anti-MuSK antibody titers as confirmed at screening (one retest allowed), and
- At least one of the following:
- i)-History of abnormal neuromuscular transmission test results demonstrated by single- fiber electromyography or repetitive nerve stimulation; or...
- d. MG-ADL score of 5 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items. e. QMG score of 11 or...
- g. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective contraception...
You likely can't join if
- Any condition that, in the opinion of the Investigator, would place the patient at unacceptable risk of complications, interfere with evaluation of...
- Lactating or pregnant females, or females who intend to become pregnant anytime from signing the informed consent form (ICF) throughout the RCP plus...
- History of drug or alcohol abuse within \< 1 year prior to screening, or any condition associated with poor compliance as judged by the Investigator.
- Site staff and their family members.
- Currently committed to an institution by way of official or judicial order.
- people diagnosed with congenital myasthenic syndromes.
See the full eligibility criteria
- a. Positive serologic test for anti-AChR or anti-MuSK antibody titers as confirmed at screening (one retest allowed), and
- At least one of the following:
- i)-History of abnormal neuromuscular transmission test results demonstrated by single- fiber electromyography or repetitive nerve stimulation; or ii)-History of positive anticholinesterase test (eg, edrophonium chloride...
- d. MG-ADL score of 5 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items. e. QMG score of 11 or greater at screening and at randomization. f. Willing and able to comply...
- g. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective contraception method (Table 1) from the time of screening and for 12 months after...
- i. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom from Day 1 for the duration of the study and for 3 months after the last dose of IP. Because male condom...
- Any condition that, in the opinion of the Investigator, would place the patient at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of patient safety or study...
- Lactating or pregnant females, or females who intend to become pregnant anytime from signing the informed consent form (ICF) throughout the RCP plus 6 months following last dose of IP.
- History of drug or alcohol abuse within \< 1 year prior to screening, or any condition associated with poor compliance as judged by the Investigator.
- Site staff and their family members.
- Currently committed to an institution by way of official or judicial order.
- people diagnosed with congenital myasthenic syndromes.
- Known immunodeficiency disorder, including human immunodeficiency virus (HIV) infection.
- Thymectomy within ≤ 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP. 10\. Receipt of the following medications or treatments at any time prior to randomization:
- Alemtuzumab (Lemtrada®, Campath®)
- Total lymphoid irradiation
- Bone marrow transplant
- T-cell vaccination therapy
- Natalizumab (Tysabri®) 10. Receipt of ANY immunosuppressive treatment (excluding corticosteroids) at ANY time prior to randomization (such as Azathioprine, Mycophenolate mofetil or Mycophenolic acid, Cyclosporine...
- Prednisone \< 20 mg/day or \< 40 mg over a 2-day period (or equivalent dose of other corticosteroids)
- Pyridostigmine \> 480 mg/day or unstable dose in the 2 weeks prior to Day 1 13. Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 half-lives of the...
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.