Rituximab and Ocrelizumab in Serum With Multiple Sclerosis

NCT06663111 | Recruiting

• 1 other identifier: 228768
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

ROS-MS is a clinical pharmacological substudy to the OVERLORD-MS study (NCT04578639), designed to examine the possibilities of personalized treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Serum drug concentration measured using liquid chromatography tandem mass spectrometry (LC-MS/MS)

  The serum concentration of rituximab or ocrelizumab after drug infusion (maximum serum concentration (Cmax)) and 2, 4, 8, 12, 24 weeks thereafter.

  Up to 24 weeks (during one cycle of treatment, injection of rituximab or ocrelizumab is scheduled every 6 months)

Interventions

Blood samples for PK OTHER

Blood sampled for pharmacokinetic study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In OVERLORD-MS, treatment-naïve male and female patients aged 18-60 years, with newly diagnosed multiple sclerosis, are randomized 2:1 to treatment with rituximab or ocrelizumab. In the sub-study ROS-MS, patients are recruited from the patients included i OVERLORD-MS.

You may qualify if:

• Included in OVERLORD-MS (NCT04578639)
• Willing to attend laboratory for blood sample collection at scheduled time points

You may not qualify if:

• \* Not willing to attend laboratory for blood sample collection at scheduled time points

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital, Deparment of medical biochemistry and pharmacology

Bergen, Vestland, 5021, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples.

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

• Trond T. Serkland, M.D.

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Silje Skrede, M.D., PhD

  University of Bergen

  STUDY DIRECTOR

Central Study Contacts

Trond T. Serkland, M.D.

CONTACT

004755975563; trond.tretteberg.serkland@helse-bergen.no

Silje Skrede, M.D., PhD

CONTACT

silje.skrede@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: October 29, 2024
• Study Start: March 15, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)