NCT05566756Completed
Study Evaluating Kesimpta® Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies
A Non-interventional Study Evaluating Kesimpta® (Ofatumumab) Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies [KAIROS]
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
KAIROS was a prospective, multicenter, non-interventional study (NIS) in Germany. Prospective, primary data was 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 was collected including disease duration, EDSS, MRI parameters and relapses.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 307 (actual)
- First submitted
- 30 Sept 2022
- Start date
- 28 Oct 2022
- Primary completion date
- 28 May 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT05566756
What you commit to
- Study type: Observational
- Participants enrolled: 307
- From 28 Oct 2022 to the primary completion date, 28 May 2025
- 34 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Subjects who are not able to provide consent due to incapable judgement
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab
Who the study is looking for
- Written informed consent must be obtained before participating in the study
- Diagnosis of RMS per McDonald Criteria (2017) (Thompson, Banwell et al. 2018)
- Prior treatment with EU approved DMT for MS other than ofatumumab
- 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
- Ofatumumab treatment in line with the German label
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.