A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis (Rinomax)
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ClinicalTrials.gov Identifier: NCT02950155 |
Recruitment Status : Unknown
Verified March 2020 by Fredrik Piehl, Karolinska Institutet.
Recruitment status was: Active, not recruiting
First Posted : October 31, 2016
Last Update Posted : March 13, 2020
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Condition or disease | Intervention/treatment | Phase |
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Generalized Myasthenia Gravis | Drug: Rituximab Drug: Sodium Chloride solution | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | October 16, 2016 |
Estimated Primary Completion Date : | January 30, 2021 |
Estimated Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
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Experimental: Rituximab
A single infusion at a dose of 500 mg of Mabthera/Rituximab.
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Drug: Rituximab
A single infusion at a dose of 500 mg Mabthera/Rituximab.
Other Name: Mabthera |
Sham Comparator: Sodium Chloride solution
A single infusion with sodium chloride solution.
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Drug: Sodium Chloride solution
A single infusion of Placebo/Sham.
Other Name: Sodium Chloride |
- Percentage of patients with quantitative MG ascore (QMG) score ≤ 4 and a daily Prednisolon dose of ≤ 10mg at 16 weeks after administration of study drug/placebo. [ Time Frame: 16 weeks ]QMG is measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
- QMG score at 24 weeks after administration of study drug/placebo. [ Time Frame: 24 weeks ]QMG is measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
- MG-activities of daily living (ADL) score at 16 weeks after administration of study drug/placebo [ Time Frame: 16 weeks ]MG-ADL is a patient-reported outcome measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
- MG-quality of life (QoL) score at 16 weeks after administration of study drug/placebo [ Time Frame: 16 weeks ]MG-QoL is a patient-reported outcome measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
- 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. [ Time Frame: 24 weeks ]QMG is measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
- QMG scores at 16, 36 and 48 weeks after administration of study drug/placebo. [ Time Frame: 16, 36 and 48 weeks ]QMG is measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
- MG-activities of daily living (ADL) score at 24, 36 and 48 weeks after administration of study drug/placebo [ Time Frame: 24, 36 and 48 weeks ]MG-ADL is a patient-reported outcome measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
- EQ5D score at 16, 24, 36 and 48 weeks after administration of study drug/placebo [ Time Frame: 16, 24, 36 and 48 weeks ]The EQ5D scale is a generic QoL score measured under standardized conditions with at least 12 hours since last intake of choline e
- MG-QoL score at 24, 36 and 48 weeks after administration of study drug/placebo [ Time Frame: 24, 36 and 48 weeks ]MG-QoL is a patient-reported outcome measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
- Number of hospital admissions for MG worsening during week 0 to 48 after administration of study drug/placebo [ Time Frame: 0 - 48 weeks ]
- Rescue treatments during week 8 to 48 after administration of study drug/placebo [ Time Frame: 8 - 48 weeks ]Rescue treatments comprise i.v immunoglobulins, plasma exchange and high dose corticosteroids

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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The diagnosis of MG should be determined with the following:
Clinical neurological status with motor symptoms consistent with MG and at least two of the following:
a positive serologic test for anti-acetylcholine receptor antibody (AChR) and/or b. typical MG findings on neurophysiological testing of neuromuscular transmission with single fiber electromyography (SFEMG) and / or repetitive nerve stimulation (RNS), and / or c. Positive anti-choline esterase-test, e.g. edrophoniumchloride or improvement of MG symptoms with oral cholinesterase inhibitors as judged by the treating physician.
- 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
- Previous use of immunosuppressive drugs, including rituximab, except prednisolone at a dose of up to 40mg daily for less than 3 months. This does not apply to treatment with immunosuppressive drugs / corticosteroids (except rituximab) for other indications than MG, provided at least 12 months have passed since treatment was terminated.
- Suspected hypersensitivity to the study drug
- Participation in another trial of study drug within 30 days prior to screening.
- Any medical condition which, according to the study physician's opinion, may interfere with the patient's participation in the study, poses additional risks for the patient, or that complicate the assessment of patients.
- Vaccination within 4 weeks before inclusion.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950155
Sweden | |
Karolinska University Hospital | |
Stockholm, Solna, Sweden, 171 76 |
Principal Investigator: | Fredrik Piehl, Professor | Dept Clinical Neuroscience Karolinska Institutet, Neuroimmunology Unit |
Responsible Party: | Fredrik Piehl, Professor, MD, Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT02950155 |
Other Study ID Numbers: |
EudraCT 2015-005749-30 |
First Posted: | October 31, 2016 Key Record Dates |
Last Update Posted: | March 13, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Myasthenia Gravis Muscle Weakness Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site Neoplasms Paraneoplastic Syndromes |
Autoimmune Diseases of the Nervous System Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |