Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
Danish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple Sclerosis
The DanNORMS study is a phase 3, non-inferiority clinical trial examining whether treatment of active multiple sclerosis with rituximab is non-inferior to ocrelizumab regarding efficacy and safety.
The DanNORMS study will include patients with active multiple sclerosis aged 18-65 years. Patients will be randomized in a 2:1 ratio to either rituximab or ocrelizumab. The study duration is 24 months for the core-phase, and patients can continue in a long-term follow-up phase for additional 36 months with possibility for extended interval dosing guided by CD19+ B cell count. The primary endpoint is the percentage of patients without new or enlarging T2 white matter lesions on brain MRI scans from month 6 to month 24, which will be assessed by radiologists blinded to the treatments status. The study will evaluate a number of efficacy and safety endpoints using clinical, MRI, routine blood samples and research biomarkers. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01945359 -
Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design
|
N/A | |
| Completed |
NCT01450124 -
Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA)
|
Phase 2 | |
| Completed |
NCT01456416 -
Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities
|
Phase 4 | |
| Recruiting |
NCT05277740 -
Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
|
||
| Completed |
NCT03718247 -
Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS
|
||
| Active, not recruiting |
NCT03471338 -
Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
|
N/A | |
| Recruiting |
NCT03004079 -
Clinical Importance of Glucose Regulation in Relapsing MS
|
||
| Terminated |
NCT02266121 -
Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis
|
N/A | |
| Completed |
NCT01963611 -
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
|
Phase 2 | |
| Active, not recruiting |
NCT01464905 -
Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
|
Phase 3 | |
| Completed |
NCT01225289 -
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
|
Phase 4 | |
| Recruiting |
NCT00242268 -
A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
|
Phase 3 | |
| Completed |
NCT00203086 -
A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis
|
Phase 4 | |
| Completed |
NCT00616187 -
Atorvastatin in Relapsing-Remitting Multiple Sclerosis
|
Phase 2 | |
| Recruiting |
NCT06083753 -
Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis
|
Phase 2 | |
| Active, not recruiting |
NCT04602390 -
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
|
Phase 1 | |
| Recruiting |
NCT06159712 -
Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT04604041 -
Investigation of Subclinical Markers of Multiple Sclerosis
|
||
| Terminated |
NCT03536559 -
Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT02490982 -
Teriflunomide Observational Effectiveness Study
|