18 and older, any sex, with Generalized Myasthenia Gravis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.Primary· 16 weeks
The Quantitative Myasthenia Gravis (QMG) score is a physician rated disease activity score that ranges from 0 to 39, where lower indicates better outcome. QMG was measured at 16 weeks under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors. Patients meeting the primary outcome had a QMG score of 4 or less whilst also requiring a daily oral Prednisolone dose of 10 mg or less.
Group
Value
95% CI
Rituximab
17
Sodium Chloride Solution
6
Change in QMG Score From Week 0 to Week 24 After Administration of Study Drug/Placebo.Secondary· 24 weeks
The Quantitative Myasthenia Gravis (QMG) score is a physician rated disease activity score that ranges from 0 to 39, where lower indicates better outcome. QMG was measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors. Change in QMG scores between the two time points was compared between groups.
Group
Value
95% CI
Rituximab
-6.9
± 5.6
Sodium Chloride Solution
-5.8
± 4.6
Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score From Week 0 to Week 16 After Administration of Study Drug/PlaceboSecondary· 16 weeks
The Myasthenia Gravis Activities of Daily Living (MG-ADL) score is a patient rated disease activity score that ranges from 0 to 24, where lower indicates better outcome. MG-ADL was assessed at 16 weeks under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors. Change in MG-ADL scores between the two time points was compared between groups.
Group
Value
95% CI
Rituximab
-1.7
± 2.5
Sodium Chloride Solution
-0.5
± 3.6
Change in Myasthenia Gravis Quality of Life (QoL) Score From Week 0 to Week 16 After Administration of Study Drug/Placebo.Secondary· 16 weeks
The Myasthenia Quality of Life (QoL) score is a patient rated quality of life score that ranges from 0 to 60, where lower indicates better outcome. Change in MG-QoL scores between the two time points was compared between groups.
.
Group
Value
95% CI
Rituximab
-9.2
± 9.2
Sodium Chloride Solution
-7.0
± 9.3
Percentage of Patients With Quantitative MG Ascore (QMG) Score ≤ 4 and a Daily Prednisolon Dose of ≤ 10mg at 24 Weeks After Administration of Study Drug/Placebo.Secondary· 24 weeks
The Quantitative Myasthenia Gravis (QMG) score is a physician rated disease activity score that ranges from 0 to 39, where lower indicates better outcome. QMG was measured at 24 weeks under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors. Patients meeting the primary outcome had a QMG score of 4 or less whilst also requiring a daily oral Prednisolone dose of 10 mg or less.
Group
Value
95% CI
Rituximab
18
Sodium Chloride Solution
8
Number of Hospital Admissions for MG Worsening During Week 0 to 24 After Administration of Study Drug/PlaceboSecondary· 24 weeks
The total number of hospital admissions for MG worsening during week 0 to 24 of the study.
Group
Value
95% CI
Rituximab
0
Placebo
3
Rescue Treatments During Week 8 to 24 After Administration of Study Drug/PlaceboSecondary· 8 - 24 weeks
The number of events when rescue treatment was given during week 8-24 of the study. Rescue treatments were defined as i.v immunoglobulins, plasma exchange, high dose corticosteroids and biologics (rituximab, tocilizumab).
Group
Value
95% CI
Rituximab
1
Placebo
8
Adverse events — posted to ClinicalTrials.gov
Time frame: 48 weeks, i.e. time from baseline to last follow up..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rituximab
Serious: 5/25 (20%)
Deaths: 1/25
Sodium Chloride Solution
Serious: 4/22 (18%)
Deaths: 0/22
Serious adverse events (10 terms)
Reaction
System
Rituximab
Sodium Chloride Solution
Chest pain
Cardiac disorders
—
—
Anemia
Blood and lymphatic system disorders
—
—
Pneumonia
Infections and infestations
—
—
Septicaemia
Infections and infestations
—
—
Nausea
Nervous system disorders
—
—
Ileus
Gastrointestinal disorders
—
—
Asystole
Cardiac disorders
—
—
Vertebral compression fracture
Musculoskeletal and connective tissue disorders
—
—
Syncope
Cardiac disorders
—
—
Thymoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
· Phase 2
· not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP)
· Phase 1
· not yet recruiting
NCT06965114 — Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
· Phase 1, PHASE2
· recruiting
NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu
· Phase 3
· recruiting
Other recruiting trials for Generalized Myasthenia Gravis
Currently open trials in the same condition.
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen
· Phase 2
· recruiting
NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
· Phase 4
· recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip
· recruiting
NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With
· Phase 2
· recruiting
NCT06967480 — Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fredrik Piehl
Last refreshed: 26 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02950155.