- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02950155
A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis (Rinomax)
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Solna
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Stockholm, Solna, Sweden, 171 76
- Karolinska University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rituximab
A single infusion at a dose of 500 mg of Mabthera/Rituximab.
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A single infusion at a dose of 500 mg Mabthera/Rituximab.
Other Names:
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Sham Comparator: Sodium Chloride solution
A single infusion with sodium chloride solution.
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A single infusion of Placebo/Sham.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QMG score at 24 weeks after administration of study drug/placebo.
Time Frame: 24 weeks
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QMG is measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
|
24 weeks
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MG-activities of daily living (ADL) score at 16 weeks after administration of study drug/placebo
Time Frame: 16 weeks
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MG-ADL is a patient-reported outcome measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
|
16 weeks
|
MG-quality of life (QoL) score at 16 weeks after administration of study drug/placebo
Time Frame: 16 weeks
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MG-QoL is a patient-reported outcome measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
|
16 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 weeks
|
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
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16, 36 and 48 weeks
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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
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MG-ADL is a patient-reported outcome measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
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24, 36 and 48 weeks
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EQ5D score at 16, 24, 36 and 48 weeks after administration of study drug/placebo
Time Frame: 16, 24, 36 and 48 weeks
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The EQ5D scale is a generic QoL score measured under standardized conditions with at least 12 hours since last intake of choline e
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16, 24, 36 and 48 weeks
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MG-QoL score at 24, 36 and 48 weeks after administration of study drug/placebo
Time Frame: 24, 36 and 48 weeks
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MG-QoL is a patient-reported outcome measured under standardized conditions with at least 12 hours since last intake of choline esterase inhibitors
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24, 36 and 48 weeks
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Number of hospital admissions for MG worsening during week 0 to 48 after administration of study drug/placebo
Time Frame: 0 - 48 weeks
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0 - 48 weeks
|
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Rescue treatments during week 8 to 48 after administration of study drug/placebo
Time Frame: 8 - 48 weeks
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Rescue treatments comprise i.v immunoglobulins, plasma exchange and high dose corticosteroids
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8 - 48 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fredrik Piehl, Professor, Dept Clinical Neuroscience Karolinska Institutet, Neuroimmunology Unit
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neuromuscular Manifestations
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Muscle Weakness
- Myasthenia Gravis
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- EudraCT 2015-005749-30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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