A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple Sclerosis

Phase 1

• Conditions: Relapsing Multiple Sclerosis (RMS); MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001505-24-NO
• Lead Sponsor: Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-28
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 264

Inclusion Criteria

- Age between 18 and 65 years
- A diagnosis of relapsing MS (RMS) according to the 2017 McDonald criteria
- Disease activity seen as either a clinical relapse or MRI activity during the last 12 months
- EDSS between 0 and 5.5
- Thrombocytes and leukocytes within normal range, and lymphocytes above 0.8 x10 9/L before first dose of study medication
A) For women of childbearing potential: accepting to use adequate contraception in the trial period. If randomized to cladribine, women who use systemic hormonal contraception must accept to use additional barrier contraception during each treatment cycle and for four weeks after each treatment cycle.
B) For men: If randomized to cladribine, accepting to use adequate contraception in the safety period of 6 months after each treatment cycle.
- Able to understand written and spoken Norwegian or English
- Able to complete treatment or follow-ups in the study (e.g. contraindications for MRI, severe psychiatric disease, drug abuse or plans of moving)
- Signed informed consent
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 264
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any contraindication or increased risk of side-effects from rituximab or cladribine (such as ongoing acute or chronic infection, live vaccination less than 4 weeks before start of treatment or planned live vaccination, immunocompromised, previous or active malignant disease, ongoing glucocorticoid treatment or allergy against any products of the medication)
- Previous use of any of cladribine, rituximab, alemtuzumab, ocrelizumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression with long lasting effects
- Current pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified