Health TrialsbyHealthPanel

Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)

ConditionMyasthenia Gravis, Generalized
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 results.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rituximab

    Drug

    Rituximab 1000 mg IV on RCP days 1 and 15

  • Placebo

    Other intervention

    Placebo 1000 mg IV on RCP days 1 and 15

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: RituximabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To assess whether rituximab can reduce MG-related functional impairment.

Change from baseline in Quantitative Myasthenia Gravis Score (QMG) at week 12 (3 months) of the RCP. QMG score 0 - 39 A higher score means a worse outcome

Time frame
12 weeks

Secondary outcomes

1

To evaluate the effect of rituximab on corticosteroid usage.

Change in corticosteroid dosage from week 12 to the end of the RCP.

Time frame
48 weeks
2

To evaluate the effect of rituximab on MG-related disability.

Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at week 12. MG-ADL score 0 - 24 A higher score means a worse outcome

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov
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