Relapsing Forms of Multiple SclerosisTIMIOSNCT04676555
Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis
An observational study of Relapsing Forms of Multiple Sclerosis, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Relapsing Forms of Multiple Sclerosis
- What is being tested?
- Ocrelizumab and Ofatumumab
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 May 2021to 21 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed of RMS will be recruited if they have been prescribed either Ocrelizumab of Ofatumumab. The person accompanying the patient will be invited to participate as a caregiver.
Who may be able to join
- Adult patients of 18 or more years of age.
- Patients with confirmed diagnosis of RMS (CIS, RRMS or aSPMS) following 2017 McDonnald criteria.
- Patients currently prescribed with Ocrelizumab or Ofatumumab to treat MS according to the Summary of Product Characteristics (SmPC). The decision must be based on patient disease and taken before the decision of inviting the patient to participate in this study.
- Patients literate in English.
- Patients must provide informed consent to participate in the study.
Who cannot join
- Patients currently participating in any other RMS clinical trial.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Investigative Site
Lutherville, Maryland, 21093
About this study
This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia.
Read the detailed description
Patients with RMS receiving Ocrelizumab or Ofatumumab will be recruited to measure the time spend for Healthcare Providers (HCP) (neurologist, nurse and hospital pharmacist) on preparing, administering the medication and following up with the patient.
- Conditions
- Relapsing Forms of Multiple Sclerosis
- Being tested
- Ocrelizumab, Ofatumumab
- Keywords
- Relapsing forms of Multiple Sclerosis, RMS, Ocrelizumab, Ofatumumab, TIMIOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
There is no treatment allocation. Patients administered Ocrelizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
OfatumumabDrug
There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Ocrelizumab | Ocrelizumab is administered intravenously (IV) under the guidance of a specialized physician and followed by one-hour observation after the infusion. It requires a corticosteroid pre-medication and some antipyretics may also be administered. Receives: Drug: Ocrelizumab | |
| Ofatumumab | Ofatumumab is administered through a subcutaneous injection and allows self-administration after training. Receives: Drug: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent by Healthcare Providers (staff) in the preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab
Describe and compare the time spent by Healthcare Providers (in minutes) in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab in patients with Relapsing forms of Multiple Sclerosis at each event (initial, loading and subsequent doses).
Measured: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Secondary outcomes (6)
Healthcare resources used, in terms of consumables in the treatment preparation and administration of Ocrelizumab and Ofatumumab
Describe and compare the healthcare resources used, in terms of number of consumables used, in the treatment preparation and administration of Ocrelizumab and Ofatumumab for RMS patients at each event.
Measured: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Cost of staff and consumables used in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab
Describe and compare the cost of staff and consumables used in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab for RMS patients at each event.
Measured: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Healthcare resources used, in terms of staff time in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab
Describe and compare the healthcare resources used, in terms of staff time in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab in RMS patients at each event.
Measured: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Healthcare resources used, in terms of consumables in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab
Describe and compare the healthcare resources used, in terms of number of consumables used in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab in RMS patients at each event.
Measured: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Multiple sclerosis (WPAI:MS
Describe and compare as assessed by the Work Productivity and Activity Impairment Questionnaire: Multiple sclerosis (WPAI:MS) at each event.
The WPAI measures four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Overall productivity loss (overall impairment / absenteeism plus presenteeism); 4. Usual activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Measured: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG)
Describe and compare as assessed by the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG), at each event.
The WPAI measures four types of scores: 1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Overall productivity loss (overall impairment / absenteeism plus presenteeism); 4. Usual activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Measured: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start11 May 2021
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Forms of Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676555
- Sponsor's protocol ID
- COMB157G2004
- Acronym
- TIMIOS
- Status last verified
- Oct 2022
- First submitted
- 16 Dec 2020
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04676555
- Acronym / sponsor ID
- TIMIOS / COMB157G2004
- Conditions
- Relapsing Forms of Multiple Sclerosis
- Keywords
- Relapsing forms of Multiple Sclerosis, RMS, Ocrelizumab, Ofatumumab, TIMIOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia.
Detailed description
Patients with RMS receiving Ocrelizumab or Ofatumumab will be recruited to measure the time spend for Healthcare Providers (HCP) (neurologist, nurse and hospital pharmacist) on preparing, administering the medication and following up with the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ocrelizumab | – | Drug: OcrelizumabOcrelizumab is administered intravenously (IV) under the guidance of a specialized physician and followed by one-hour observation after the infusion. It requires a corticosteroid pre-medication and some antipyretics may also be administered. |
| Ofatumumab | – | Drug: OfatumumabOfatumumab is administered through a subcutaneous injection and allows self-administration after training. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed of RMS will be recruited if they have been prescribed either Ocrelizumab of Ofatumumab. The person accompanying the patient will be invited to participate as a caregiver.
Key inclusion criteria (5 listed)
- Adult patients of 18 or more years of age.
- Patients with confirmed diagnosis of RMS (CIS, RRMS or aSPMS) following 2017 McDonnald criteria.
- Patients currently prescribed with Ocrelizumab or Ofatumumab to treat MS according to the Summary of Product Characteristics (SmPC). The decision must be based on patient disease and taken before the decision of inviting the patient to participate in this study.
- Patients literate in English.
- Patients must provide informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients currently participating in any other RMS clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcrelizumabThere is no treatment allocation. Patients administered Ocrelizumab by prescription that have started before inclusion of the patient into the study will be enrolled. | Drug | Ocrelizumab |
| OfatumumabThere is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled. | Drug | Ofatumumab |
Primary outcome
Time spent by Healthcare Providers (staff) in the preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab
Time frame: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Describe and compare the time spent by Healthcare Providers (in minutes) in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab in patients with Relapsing forms of Multiple Sclerosis at each event (initial, loading and subsequent doses).
6 secondary outcomes
Healthcare resources used, in terms of consumables in the treatment preparation and administration of Ocrelizumab and Ofatumumab
Time frame: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Cost of staff and consumables used in the treatment preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab
Time frame: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Healthcare resources used, in terms of staff time in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab
Time frame: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Healthcare resources used, in terms of consumables in managing the adverse events occurred during the administration and post treatment observation of Ocrelizumab and Ofatumumab
Time frame: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Multiple sclerosis (WPAI:MS
Time frame: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Indirect cost as assessed by the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG)
Time frame: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Forms of Multiple Sclerosis, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent by Healthcare Providers (staff) in the preparation, administration and post-treatment observation of Ocrelizumab and Ofatumumab (time frame: Ocrelizumab: Initial dose (week 0), Loading dose (week 2), Subsequent dose (month 6, month 12, or month 18). Ofatumumab: Initial dose (week 0), Loading dose (week 1 or week 2), Subsequent dose (week 4, week 8, or week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.