CompletedPhase 3

A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis

Sweden47 participantsStarted 2016-10-16

Plain-language summary

A randomized, double-blind, placebo-controlled multicenter study evaluating the safety and efficacy of Rituximab (Mabthera®) in patients with new onset generalized myasthenia gravis (MG).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with oculobulbar, bulbar or generalized MG ≥ 18 years of age and with onset of generalized symptoms or neurophysiological detection of generalized disease not more than 12 months ago.
✓. The diagnosis of MG should be determined with the following:
✓. MGFA Class II to IV at screening.
✓. Quantitative MG score ≥ 6 at screening
✓. Women of childbearing potential must have a negative pregnancy test.
✓. Patients must have provided written informed consent.
✓. Patients must be able and willing to comply with all study procedures.

Exclusion criteria

✕. Weakness only affecting ocular or periocular muscles (MGFA Class I).
✕. MG crisis at screening (MGFA Class V)
✕. Thymectomy already carried out. In order to avoid difficulties to evaluate the effect of the study drug, thymectomy, where it is indicated, should be scheduled to the follow-up period, ie after the first 24 weeks.
✕. Strong suspicion of thymoma, where thymectomy as judged by the treating physician should be done within 24 weeks.
✕. Active malignancy, if not adequately treated
✕. Pregnancy or breast-feeding.
✕. Ongoing acute or chronic viral or systemic bacterial infections including HIV, latent hepatitis B, which is clinically significant, according to the study doctor's opinion and not treated with appropriate antibiotic / antiviral drugs.
✕. Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease

What they're measuring

Percentage of Patients With Quantitative MG Score (QMG) Score ≤ 4 and a Daily Prednisolon Dose of ≤ 10mg at 16 Weeks After Administration of Study Drug/Placebo.

Timeframe: 16 weeks

Trial details

NCT IDNCT02950155

SponsorFredrik Piehl

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-30

Results submitted2022-04-08

View on ClinicalTrials.gov More Generalized Myasthenia Gravis trials