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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02950155
Date of registration: 28/10/2016
Prospective Registration: Yes
Primary sponsor: Fredrik Piehl
Public title: A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis Rinomax
Scientific 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)
Date of first enrolment: October 16, 2016
Target sample size: 47
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02950155
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Sweden
Contacts
Name:     Fredrik Piehl, Professor
Address: 
Telephone:
Email:
Affiliation:  Dept Clinical Neuroscience Karolinska Institutet, Neuroimmunology Unit
Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. 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.

3. MGFA Class II to IV at screening.

4. Quantitative MG score = 6 at screening

5. Women of childbearing potential must have a negative pregnancy test.

6. Patients must have provided written informed consent.

7. Patients must be able and willing to comply with all study procedures.

Exclusion Criteria:

1. Weakness only affecting ocular or periocular muscles (MGFA Class I).

2. MG crisis at screening (MGFA Class V)

3. 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.

4. Strong suspicion of thymoma, where thymectomy as judged by the treating physician
should be done within 24 weeks.

5. Active malignancy, if not adequately treated

6. Pregnancy or breast-feeding.

7. 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.

8. Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled
cardiac disease

9. 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.

10. Suspected hypersensitivity to the study drug

11. Participation in another trial of study drug within 30 days prior to screening.

12. 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.

13. Vaccination within 4 weeks before inclusion.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Generalized Myasthenia Gravis
Intervention(s)
Drug: Rituximab
Drug: Sodium Chloride solution
Primary Outcome(s)
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]
Secondary Outcome(s)
MG-activities of daily living (ADL) score at 16 weeks after administration of study drug/placebo [Time Frame: 16 weeks]
MG-quality of life (QoL) score at 16 weeks after administration of study drug/placebo [Time Frame: 16 weeks]
QMG score at 24 weeks after administration of study drug/placebo. [Time Frame: 24 weeks]
Secondary ID(s)
EudraCT 2015-005749-30
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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