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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: EUCTR
Last refreshed on: 6 November 2018
Main ID:  EUCTR2015-005749-30-SE
Date of registration: 28/04/2016
Prospective Registration: Yes
Primary sponsor: Karolinska Institutet
Public title: A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenght
Scientific title: A randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study - Rinomax
Date of first enrolment: 23/06/2016
Target sample size: 60
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005749-30
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Sweden
Contacts
Name: Department of Neurology    
Address:  R2:4 Karolinska University Hospital 17176 Stockholm Sweden
Telephone: +46851779840
Email: fredrik.piehl@ki.se
Affiliation:  Karolinska Institutet
Name: Department of Neurology    
Address:  R2:4 Karolinska University Hospital 17176 Stockholm Sweden
Telephone: +46851779840
Email: fredrik.piehl@ki.se
Affiliation:  Karolinska Institutet
Key inclusion & exclusion criteria
Inclusion criteria:
1. Patients with oculo bulbar, bulbar or generalized MG = 18 years of age and not more than 12 months ago estimated the onset of symptoms of generalized symptoms or neurophysiological detection of generalized disease.
2. The diagnosis of MG should be produced by the following tests:
Clinical neurological status with motor effects consistent with MG, and at least two of the following:
A positive serological test for anti-acetylcholine receptor antibodies (AChR),
and / or
b. For MG typical deviation during neurophysiological testing of the neuromuscular transmission with single fiber electromyography (SFEMG) and / or repetitive nerve stimulation (RNS)
and/or
c Positive choline esterase blocker response, e.g. edrophonium and/or oral cholinesterase inhibitors, as judged by the treating physician.
3. MGFA clinical classification 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 given written informed consent.
7. Patients must be able and willing to comply with all study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1. Weakness that only affect ocular or periocular muscles (MGFA class I).
2. MG crisis at screening (MGFA Class V)
3. Already implemented thymectomy. In order to avoid difficulties to evaluate the effect of the study drug, thymectomy, in cases where it is indicated, should be scheduled to the follow-up period, ie after the first 24 weeks.
4. Strong suspicion of thymoma, where a thymectomy is indicated within 24 weeks according to the treating physician.
5. Active tumor disease, if not adequately treated.
6. Pregnancy and lactation.
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 antibiotics / antiviral drug.
8. Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease.
9. 9. Previously use of immunosuppressive drugs, including rituximab, azathioprine, cyclosporine and MMF. Prednisolone at a dose of =40mg / d within 3 months and IVIG and PLEX 12 months of the screening date is not an exclusion criterion. Also note that this does not apply to treatment with immunosuppressive drugs / corticosteroids (except rituximab) in another indication than MG, provided that it is > 12 months since the treatment ended.10. Hypersensitivity to the active substance or to murine proteins or to any of the excipients of the study drug
11. Participation in another trial to study drug or exposure to any other study drugs, study product or study procedures 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, pose any additional risk to the patient, or that complicate the assessment of patients


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
New onset myasthenia gravis
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: To evaluate if rituximab is more effective than placebo to achieve minimal clinical MG symptoms without need of high doses of oral corticosteroids at 16 weeks after treatment
Primary end point(s): Percentage of patients with a QMG score =4 and daily prednisone dose =10mg 16 weeks after treatment
Secondary Objective: Is Rituximab more effective than placebo in achieving improvement in standardized QMG at 24 weeks after treatment?

Is Rituximab more effective than placebo in achieving improvement in the ability to perform activities of daily live at 16 weeks after treatment?

Is Rituximab more effective than placebo in achieving improvement in experienced quality of life at 16 weeks after treatment?
Timepoint(s) of evaluation of this end point: At 16 weeks after treatment
Secondary Outcome(s)
Secondary end point(s): QMG score at 24 weeks after treatment
MG-ADL score at 16 weeks after treatment
MG-QOL scores at 16 weeks after treatment
Timepoint(s) of evaluation of this end point: At 16 and 24 weeks after treatment
Secondary ID(s)
2015-00887
Source(s) of Monetary Support
Swedish Research Council
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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