COMparison Between All immunoTherapies for Multiple Sclerosis.

NCT ID: NCT03193866

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3526 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2022-03-31

Brief Summary

The overarching goal of this study is to determine whether rituximab (RTX) offers effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs (DMT) in the largest real-world population-based structured prospective follow-up cohort of Relapsing-Remitting Multiple Sclerosis (RRMS) patients. The study will include both treatment naïve patients starting their first DMT and patients switching from a previous first line DMT (escalation/second-line).

Detailed Description

This is a prospective non-intervention observational prospective cohort study assessing the long-term safety and efficacy of RTX treatment in MS compared with other common MS DMTs regarding both clinical and radiological parameters in a real-life population of patients with MS.

A number of parameters will be assessed annually. These include baseline demographics, previous drug history and reasons for discontinuation, disability status (expanded disability status scale), relapses, safety and adverse events (AE), contrast enhancing T1 and newly appearing T2 lesions on magnetic resonance imaging, as well as a panel of patient reported outcome measures: Symbol Digit Modalities Test (SDMT); MS impact scale-29 (MSIS-29) Fatigue Scale for Motor and Cognitive Functions (FSMC), EuroQol-5 Dimensions (EQ-5D), the MS check scale and Treatment Satisfaction Questionnaire 9 (TSQM-9).

Retrospective data entered in medical charts and the Swedish MS registry will be included together with prospective annual structured follow up from inclusion into the study for a minimum of three years (three to nine years).

In a substudy - Covid Enhancement study - analyses will be performed regarding the effect of COVID-19 on people with MS as compared to non-MS individuals and also if there is any indication that a particular DMD is associated with a risk to contract a more severe COVID-19. The analyses will primarily be performed in official health care databases.

Conditions

Relapsing-remitting Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

Rituximab

Comparisons of efficacy and safety between rituximab and all other frequently used immunomodulating drugs against multiple sclerosis

Intervention Type: DRUG

Other Intervention Names

Natalizumab; Fingolimod; Alemtuzumab; Interferon-beta; Glatiramer acetate; Dimethyl Fumarate

Eligibility Criteria

Inclusion Criteria

The study population consists of all patients with Clinically Isolated Syndrome (CIS) or RRMS who;

• Initiate a first MS DMT (treatment naïve), or Initiate a second ever DMT, of a different drug class than the first, regardless of time between drugs or reason for discontinuation("switchers") from 1st Jan 2011 to 30st June 2018, and
• Are followed at any of the University clinics of Sweden, and
• Consent to participation in COMBAT-MS core, and
• Are expected to be capable to follow study assessments.

Exclusion Criteria

• Patients with progressive forms of MS at start of therapy are not eligible

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Kaiser Foundation Research Institute

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Fredrik Piehl

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredrik Piehl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Anders Svenningsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Anna Fogdell-Hahn, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Ingrid Kockum, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Thomas Frisell, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Annette Langer-Gould, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanent Southern California, Los Angeles, USA

Locations

Fredrik Piehl

Stockholm, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

COMBAT-MS

Identifier Type: -

Identifier Source: org_study_id