Multiple Sclerosis Clinical Trial
Official title:
A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients
The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS patients. A 48-week treatment period followed by an individualized follow-up period until normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels.
The trial consists of two phases, a 48 week treatment period, followed by an individualized
treatment period of up to two years.
Patients are treated in cohorts of increasing doses (100 mg, 300 mg and 700 mg) with 12
patients in each dose cohort. Within each cohort patients are randomized asymmetrically in a
2:1 ratio such that eight patients will receive ofatumumab and four patients will receive
placebo. After 24 weeks the patients randomized to placebo will be treated with the active
dose for the cohort. For blinding purposes, patients randomized to the active dose will be
treated with placebo after 24 weeks. Thus, each patient will receive two administrations of
trial product with 24 weeks follow-up resulting in a total treatment period of 48 weeks
duration. An Independent Data Monitoring Committee (IDMC) will review and evaluate the
safety data of each cohort, a minimum of 4 weeks data including the week 4 Magnetic
Resonance Imaging (MRI) from at least 10 patients, to consider if progression to the next
higher dose cohort is acceptable.
The trial product is administered as two infusions separated by two weeks. Clinical
assessment and Gadolinium enhanced (Gd-enhanced) MRI scan will be performed at weeks -4, 0,
2, 4, and every 4 weeks until week 48. The MRI scan at week 2 is carried out for safety
assessment prior to administering the second infusion in the first treatment course. When
patients in all dose cohorts have been dosed and have had week 4 MRI scans performed, an
IDMC will review all available safety data.
After completion of week 48 patients will be followed to monitor B-cell and IgG
normalization. B-cell levels will be monitored every 12 weeks until CD19+ cells have
returned to baseline level (Visit 3) or normalized level. If the B-cell levels are not
normalized after two years the patient should be followed until either the IgG or the B-cell
levels are normalized (see Section 9.2.4 for details). During this period Gd-enhanced MRI
follow up scans will be performed every 12 weeks to evaluate potential rebound, safety and
for Progressive Multifocal Leukoencephalopathy (PML) monitoring.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |