A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis.

Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital0 sites200 target enrollmentApril 24, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital
Enrollment: 200
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

April 24, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital

•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:

•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.