Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, MS, Kesimpta, ofatumumab
Brief summary
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.
Detailed description
The decision for ofatumumab as routine medical treatment must have been taken independently of and prior to the study start. During the observation phase of the study, data was collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany). The prospective observational period per patient was 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 was not dictated by the protocol. The follow-up documentation took place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures were only those ordinarily applied to the therapeutic strategy and to routine clinical care, could be performed as telemedicine visits and took place as per investigator's discretion.
Interventions
OTHEROfatumumab
There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for recent therapy switch to ofatumumab | Baseline | Reasons for recent therapy switch to ofatumumab will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of missed ofatumumab doses | 12 months | Proportion of missed ofatumumab doses within one year, defined as the difference between number of planned doses and number of administered doses |
| Number of patients by reasons for treatment interruptions | 12 months | Reasons for treatment interruptions per patient will be collected |
| Number of treatment interruptions per patient | 12 months | Number of treatment interruptions per patient will be collected |
| Duration of treatment interruptions per patient | 12 months | Duration of treatment interruptions per patient will be collected |
| Proportion of patient subgroups with and without 100% adherence depending on different characteristics | 12 months | Proportion of patient subgroups with and without 100% adherence depending on different characteristics, defined as patients with matching number of planned doses and number of administered doses within 1 year (e.g., previous experience with sub-cutaneous therapy) |
| Proportion of patients permanently discontinuing ofatumumab during the study by reason for discontinuation | 12 months | Proportion of patients permanently discontinuing ofatumumab during the study by reasons for discontinuation will be collected |
| Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT | 12 months | Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT |
| Change on Multiple Sclerosis Impact Scale 29 (MSIS-29) as compared to baseline in general and depending on reasons for treatment switch | Baseline, month 6, month 12 | MSIS-29 is a 29-item, self administered questionnaire that includes two domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day-to-day life. The questions in the scale ask the subjects for their views about the impact of MS on their day to-day life during the past 2 weeks. Analysis will be done depending on the reasons for treatment switch. |
| Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4 as compared to baseline in general and depending on reasons for treatment switch | Baseline, month 6, month 12 | The TSQM Version 1.4 comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the subject´s last use. With the exception of item 4 (presence of side effects; yes or no), all items have 5 or 7 responses, scored from 1 (least satisfied) to 5 or 7 (most satisfied). 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow precise information to be obtained at the upper end of the score distribution. Item scores are summarized to give four domain scores, which are in turn transformed to a scale of 0 -100. |
| Fatigue Scale for Motor and Cognitive Functions (FSMC) compared to baseline in general and depending on reasons for treatment switch | Baseline, month 6, month 12 | FSMC is a 20 item scale developed as a measure of cognitive and motor fatigue for people with Multiple Sclerosis. Each item is rated on a scale from 1-5 (1:"does not apply", 5: "applies completely"). Thus, a maximum of 100 points for the total scale can be achieved. A patient who has neither motor nor cognitive fatigue would thus achieve a score of 20 for the total scale. |
| Percentage of patients with no clinical evidence of disease activity (NEDA) | Baseline, month 6, month 12 | NEDA is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening |
| Proportion of patients demonstrating the individual NEDA-3 components | Baseline, month 12 | The individual NEDA-3 components are: * proportion of patients with no confirmed MS relapse * proportion of patients with no new or enlarging T2 lesions and no Gadolinium-positive T1 lesions * proportion of patients with no six-month confirmed disability worsening |
| The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of effectiveness) or tolerability/safety reasons | 12 months | The proportion of subjects discontinuing treatment due to insufficient effectiveness or tolerability/safety reasons |
| Number of participants with injection related AEs | 12 months | injection site reaction AEs vs. injection systemic reaction AEs |
Countries
Germany
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed