A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis.
- Conditions
- Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-000721-31-SE
- Lead Sponsor
- Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
A subject will be eligible for inclusion in this study if all of the following criteria apply:
•Diagnosis of Relapsing Remitting MS according to the 2017 revised McDonald criteria OR one demyelinating episode in conjunction with at least one asymptomatic high intensity T2 lesion with size and location compatible with MS
•The patient has completed the RIFUND-MS trial and is treated with either of the study medications rituximab or DMF at the last visit of the RIFUND trial OR has been treated with rituximab with a dose regimen of 500 – 1000 mg followed by 500 mg every 6 months* for a total of up to two years as part of clinical practice
•Age 20 – 52 years (inclusive)
•EDSS 0 – 5,5 (inclusive)
•The patient is willing and able to give written informed consent, according to the judgement of the investigator.
•In fertile females, willing to comply with effective contraceptive methods. These include birth control pills, surgical sterilization of patient or partner or intrauterine device. Non-fertile women is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an FSH level in the postmenopausal range.
* Occasional extended dose interval for up to 12 months in conjunction with the COVID epidemic is allowed
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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this study if any of the following criteria ap-plies:
•Diagnosis of Progressive MS
•Previous treatment with any second-line” immunomodulatory drug, eg natalizumab, alemtuzumab**, fingolimod, or other long-acting immunosuppressive agents.
•Pregnant or lactating women
s-HCG will be tested on all women at screening, before each study-related infu-sion and in any situation where there is a reason to suspect pregnancy during the trial, eg delayed menstrual period more than five days above expected time.
•Patients having contraindication for or otherwise not compliant with MRI investi-gations
•Simultaneous treatment with other immunosuppressive drugs
•Active, severe infections
Signs of infections are assessed before inclusion and each study-related infusion through clinical examination and further evaluated by laboratory and other rele-vant investigations in case of suspected ongoing infection. Hepatitis serology (HBsAg and anti-HBc) will be evaluated before treatment onset if not tested within the previous three years.
•Severe cardiac disorder, eg signs of congestive heart failure or coronary artery disease. This will be evaluated through clinical assessment before inclusion.
•Vaccination within 4 weeks of first dose of study medication.
•Documented allergy or intolerance to any of the IP:s
•Severe psychiatric condition
** Up to 6 months initial treatment with natalizumab in conjunction with the COVID epidemic or for completing vaccination before inclusion in the trial is allowed.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method