Study Evaluating Kesimpta® Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies (KAIROS)

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Ofatumumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05566756

COMB157GDE03

Details and patient eligibility

About

KAIROS is a prospective, multicenter, non-interventional study (NIS) in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of one year (max. 1.5 years) of treatment. Additionally, medical history of participants will be collected including disease duration, EDSS, MRI parameters and relapses.

Full description

The decision for ofatumumab as routine medical treatment must be taken independently of and prior to the study start. During the observation phase of the study, data will be collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).

The prospective observational period per patient will be up to approx. one year from the time of consent (1 year ± 2 months visit window + potentially 6 months follow-up to confirm disability worsening in patients who showed increase in EDSS within 6 months prior to EOS). The observational period will not be dictated by the protocol. The follow-up documentation will take place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.

Enrollment: 307 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent must be obtained before participating in the study
2. Diagnosis of RMS per McDonald Criteria (2017) (Thompson, Banwell et al. 2018)
3. Prior treatment with EU approved DMT for MS other than ofatumumab
4. Decision for treatment initiation of ofatumumab (Kesimpta®) prior to study participation and planned initiation of ofatumumab after respective wash-out period of prior DMT (if applicable) or performed initiation of ofatumumab within the last 14 days
5. Ofatumumab treatment in line with the German label

Exclusion criteria

1. Use of investigational drugs during the study, OR within 3 months before ofatumumab initiation, OR within 5 half-lives of investigational drug before ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer
2. Subjects who are not able to provide consent due to incapable judgement
3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab

Trial design

307 participants in 1 patient group

Ofatumumab

Description:

Patients prescribed with ofatumumab

Treatment:

Other: Ofatumumab