Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis

NCT06159712 | Unknown DMC

• 1 other identifier: CoSHED
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, multi-center, non-blinded, non-randomized, non-intervention clinical trial is to compare immunologic, virologic and epigenetic factors in patients with active multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab or natalizumab in Region Midt, Denmark. It aims to answer how the immunologic, virologic and epigenetic response in these patients are compared to healthy controls, and analyze their treatment effect in relation to this response. Participants will get an extra blood sample, when they have their routine blood samples taken.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Changes in B cell populations

  Changes in B cell populations in the four treatment groups

  1 year

Other Outcomes (7)

• Relapses

  1 year

• Annualized Relapse Rate

  1 year

• T-cells, B-cell subsets and monocyte-subsets

  1 year

Study Arms (5)

Ocrelizumab

OTHER

Patients with active multiple sclerosis starting standard treatment with ocrelizumab

Other: Blood samples

Rituximab

OTHER

Patients with active multiple sclerosis starting standard treatment with rituximab

Other: Blood samples

Ofatumumab

OTHER

Patients with active multiple sclerosis starting standard treatment with ofatumumab

Other: Blood samples

Natalizumab

OTHER

Patients with active multiple sclerosis starting standard treatment with natalizumab

Other: Blood samples

Healthy controls

OTHER

An age and gender matched healthy control group

Other: Blood samples

Interventions

Blood samples OTHER

Extra blood samples

Healthy controls; Natalizumab; Ocrelizumab; Ofatumumab; Rituximab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple sclerosis diagnosis and definition of disease course according to the 2017 McDonald criteria
• Expanded disability status scale (EDSS) ≤6.5
• Signed written informed consent
• Fulfilling criteria for active MS: Treatment naïve relapsing remitting multiple sclerosis (RRMS) patients (never treated, or no DMT the previous 2 years):
• relapse previous 12 months OR
• relapse previous 12 months with severe residual symptoms and EDSS ≥ 3.0 OR
• relapse previous 12 months AND ≥9 T2 lesions on brain and/or spinal cord MRI AND
• contrast-enhancing lesion or ≥1 new or enlarging T2 lesion on brain and/or spinal cord MRI previous 12 month
• Previously treated RRMS patients:
• relapse previous 12 months OR
• contrast-enhancing lesion or ≥2 new/enlarging T2 lesions on brain and/or spinal cord MRI previous 12 months

You may not qualify if:

• Pregnancy or breast feeding
• Lack of effective contraception for women of child-bearing potential (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate \<1%)
• Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
• Known active malignant disease
• Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
• Positive test for HIV, hepatitis B or C, or tuberculosis
• Negative test for varicella zoster
• Lymphopenia grade 2 (0.5 to 0.8 × 10\^9/L) or higher grades of lymphopenia (in case of switching from fingolimod lymphopenia grade 2 can be accepted if lymphocytes are rising markedly compared to on treatment levels)
• Neutropenia grade 2 (1.0 to 1.5 × 10\^9/L) or higher grades
• Thrombocytopenia grade 2 (50 to 75 × 10\^9/L) or higher grades
• Previous treatment with alemtuzumab or hematopoietic stem-cell transplantation
• Previous treatment with cladribine, CD20-depleting antibodies, daclizumab or other immune suppressive treatment which is judged to still exert immune suppressive effect by treating physician
• Methylprednisolone treatment within 1 month of baseline visit
• Findings on the screening MRI judged to preclude participation by the treating physician
• Other diseases judged to be relevant by the treating physician

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Gødstrup Hospital: collaborator
• Regionshospitalet Viborg, Skive: collaborator
• Sorbonne University: collaborator

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Morten Stilund, MD

  University of Aarhus

  STUDY DIRECTOR

Central Study Contacts

Camilla Mærsk-Møller, MD

CONTACT

+4521392792; cammae@rm.dk

Morten Stilund, MD

CONTACT

+4578430926; mortstil@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Researchers compare immunologic, virologic and epigenetic factors in patients with multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab and natalizumab by taking extra blood samples and compare it to a healthy control group.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 7, 2023
• Study Start: November 27, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After finishing the study, available for 1 year

Locations

DK (1)