Impact of ocrelizumab on patient-reported fatigue and quality of life in participants with relapsing multiple sclerosis treated for the first time with ocrelizumab
| ISRCTN | ISRCTN55332718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55332718 |
| Secondary identifying numbers | ML42393 |
- Submission date
- 14/10/2021
- Registration date
- 02/11/2021
- Last edited
- 03/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Relapsed multiple sclerosis (RMS) is a complex disease in which the insulating layer of nerves (the myelin layer) breaks down and disturbs communication between nerve cells. This study aims to collect data on initial treatment with Ocrevus® from the routine care of patients with RMS and to analyze it.
Ocrevus® is used to treat RMS and early primary progressive multiple sclerosis (PPMS) in adult patients. Ocrevus® contains the active ingredient ocrelizumab. It is a specific type of protein called a monoclonal antibody. Antibodies work by attaching themselves to bind certain targets in the body. Ocrevus® binds to certain B cells, a type of white blood cell that is part of the immune system and plays a role in multiple sclerosis. Ocrevus® targets these specific B cells and removes them. This reduces inflammatory processes and attacks on the myelin layer, making relapse less likely to occur and slowing disease progression. Knowledge of this medicinal product can be expanded in patients with RMS and may influence long-term treatment with Ocrevus®.
Who can participate?
Patients aged between 18 years and 65 years with relapsed multiple sclerosis being treated with ocrelizumab (Ocrevus®) for the first time
What does the study involve?
The following data will be collected over a period of 2 years:
1. Demographic data: year of birth, gender
2. Employment level
3. Medical history and other illnesses, including medical and surgical history
4. History of MS disease and treatment
5. Date of first symptoms of MS and type of symptoms
6. Date of MS diagnosis and type of symptoms at diagnosis
7. Confirmation of the RMS diagnosis
8. Number of relapses per year within the last 3 years
9. All previous MS treatments and therapies, including duration and the main reason for discontinuation (if any)
10. MS status before the start of treatment
11. Magnetic resonance imaging (MRI) results within the last 12 months
12. All previous and accompanying immunomodulatory and immunosuppressive treatments including their duration
13. Any previous and accompanying medication to treat tiredness and/or depression including its dose
14. Any previous and accompanying medication within the last 3 months, especially drugs that can cause fatigue (e.g. antihistamines)
15. MS symptoms, relapses, MS type, as well as MS status and MRI since the last visit (if present)
16. Physical and mental activities (e.g. endurance and strength training)
17. State of health (e.g. smoking habits)
18. Vital signs (blood pressure, heart rate, body temperature), height and weight
19. Laboratory values: blood tests (blood count, chemistry, immunoglobulins, kidney values), data on certain immune cells (B-cell status), data on the menopause status, test for bacterial and viral infections
20. Treatment with Ocrevus® (dose, duration of infusion, type of pre-medication)
21. Questionnaire to assess the severity of the permanently increased exhaustion before the premedication of Ocrevus®
22. Evaluation of the severity of the daily form-dependent increased exhaustion before the premedication, after the pre-medication, after the Ocrevus® infusion, 2 days after the infusion (at home), and 3 months after the infusion (at home)
23. Questionnaire on the influence that multiple sclerosis has on everyday life
24. Questionnaire on impairment of work productivity and activity
25. Questionnaire to assess anxiety and depression in participants with physical diseases
26. Questionnaire for recording mental deficits
27. Serious and non-serious adverse events after the first dose of Ocrevus®, as well as reactions that occur with the procedure of infusion in related adverse events of special interest (i.e. cases of drug-induced liver damage, suspected transmission of infectious material through the study medication)
28. Date of last contact with the attending doctor
29. To assess the impact of any digital health applications (DiGA) app use on fatigue (not applicable for participants in Switzerland)
What are the possible benefits and risks of participating?
Research projects have confidentiality risks (e.g. the possibility of identifying the participant). There is no benefit to participants from providing this data, but the findings from this study may be used to improve long-term treatment with Ocrevus® in the future.
Where is the study run from?
Katholisches Klinikum Lünen/Werne GmbH (Germany)
When is the study starting and how long is it expected to run for?
November 2020 to June 2026
Who is funding the study?
1. Roche Pharma AG (Germany)
2. Roche Pharma (Schweiz) AG (Switzerland)
Contact information
Public, Scientific, Principal Investigator
Building 1
Grenzacherstrasse 124
Basel
CH-4058
Switzerland
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Multicenter non-interventional (NIS) primary data collection study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Impact of ocrelizumab on patient-reported fatigue and quality of life in relapsing multiple sclerosis patients treated for the first time with ocrelizumab (MoOzaRt): an observational study |
| Study acronym | NIS MoOzaRt |
| Study objectives | To assess the impact of ocrelizumab on patient-reported fatigue over a period of time (trait), but also at the moment of treatment (state) and the impact of other parameters, such as cognition or quality of life. |
| Ethics approval(s) | Approved 24/08/2021, Ethics Board of the State Medical Council of Baden-Württemberg (Liebknechtstr. 33, 70565 Stuttgart, Germany; +49 (0)711 76989 0; ethikkommission@laek-bw.de), ref: ML42393 |
| Health condition(s) or problem(s) studied | Multiple sclerosis (MS) |
| Intervention | Current interventions as of 28/11/2024: The treatment follows the Summary of Product Characteristics (SmPC). The initial dose of 600 milligrams (mg) ocrelizumab (Ocrevus®) is given as two separate intravenous (IV) infusions; a first infusion of 300 mg followed by a second infusion of 300 mg given 2 weeks later. Follow-up doses of ocrelizumab are given as single intravenous infusions of 600 mg every 6 months. The first 600 mg follow-up dose should be given 6 months after the first infusion of the initial dose. For participants who switch from IV infusion to subcutaneous (SC) injection of ocrelizumab after the initial infusions or later, the first SC dose of 920 mg should be given six months after the last infusion. Thereafter, a minimum interval of 5 months must be observed between each dose of ocrelizumab (IV or SC). During the 24-month observation period, participants will be assessed at the screening visit (V0) and during visits performed at month 0 (baseline, V1), around month 6 (V2), around month 12 (V3), around month 18 (V4) and around month 24 (V5, final) corresponding to routine clinical practice. Screening and baseline assessments can be performed on the same day as the first initial dose of ocrelizumab is given. Collection of Patient-Reported Outcomes (PROs) is based on the completion of questionnaires and scales by the participants using the electronic PRO system. The usage of PROs is considered non-interventional according to local regulations. “Trait fatigue” is measured at the first initial ocrelizumab infusion (baseline) and at the other visits with ocrelizumab treatment using the Fatigue Scale for Motor and Cognitive Functions (FSMC) (five assessments of “trait fatigue” expected per participant in the whole observation period). “State fatigue” is assessed by Visual Analogue Scale (VAS) three times at each visit with ocrelizumab infusion, once before, once after premedication, and once after ocrelizumab infusion. Additionally, “state fatigue” is analyzed using the electronic PRO 2 days after infusion and 3 months after each infusion visit. At month 24, the last “state fatigue” assessment is performed 2 days after infusion (24 assessments of “state fatigue” expected per participant in the observation period). PROs are recorded at the first initial dose and the four infusion visits (V2-V5, five assessments expected per participant in the observation period). Collection of PROs include completion of the questionnaires/scales Multiple Sclerosis Impact Scale - 29(MSIS-29), Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS), Hospital Anxiety and Depression Scale (HADS), and Perceived Deficits Questionnaire (PDQ-20). Further parameters, such as Expanded Disability Status Scale (EDSS), MS relapses, change of MS treatment, employment status, physical fitness, health condition (e.g., smoking habit), premedication (e.g., type of antihistamine), laboratory values (e.g., ferritin, Hemoglobin (HB) value) and use of digital health applications (DiGA) apps for MS participants with fatigue (not applicable for participants in Switzerland), as available, are recorded at each treatment. _____ Previous interventions as of 20/12/2023: The treatment follows the Summary of Product Characteristics (SmPC). The initial dose of 600 mg ocrelizumab (Ocrevus®) is given as two separate intravenous infusions; a first infusion of 300 mg followed by a second infusion of 300 mg given 2 weeks later. Follow-up doses of ocrelizumab are given as single intravenous infusions of 600 mg every 6 months. The first 600 mg follow-up dose should be given 6 months after the first infusion of the initial dose. During the 24-month observation period, participants will be assessed at the screening visit (V0) and during visits performed at month 0 (baseline, V1), around month 6 (V2), around month 12 (V3), around month 18 (V4) and around month 24 (V5, final) corresponding to routine clinical practice. Screening and baseline assessments can be performed on the same day as the first initial dose of ocrelizumab is given. Collection of Patient-Reported Outcomes (PROs) is based on the completion of questionnaires and scales by the participants using the electronic PRO system. The usage of PROs is considered non-interventional according to local regulations. “Trait fatigue” is measured at the first initial ocrelizumab infusion (baseline) and at the other visits with ocrelizumab infusion using the Fatigue Scale for Motor and Cognitive Functions (FSMC) (five assessments of “trait fatigue” expected per participant in the whole observation period). “State fatigue” is assessed by Visual Analogue Scale (VAS) three times at each visit with ocrelizumab infusion, once before, once after premedication, and once after ocrelizumab infusion. Additionally, “state fatigue” is analyzed using the electronic PRO 2 days after infusion and 3 months after each infusion visit. At month 24, the last “state fatigue” assessment is performed 2 days after infusion (24 assessments of “state fatigue” expected per participant in the observation period). PROs are recorded at the first initial dose and the four infusion visits (V2-V5, five assessments expected per participant in the observation period). Collection of PROs include completion of the questionnaires/scales Multiple Sclerosis Impact Scale (MSIS-29), Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS), Hospital Anxiety and Depression Scale (HADS), and Perceived Deficits Questionnaire (PDQ-20). Further parameters, such as Expanded Disability Status Scale (EDSS), MS relapses, change of MS treatment, employment status, physical fitness, health condition (e.g., smoking habit), premedication (e.g., type of antihistamine), laboratory values (e.g., ferritin, Hemoglobin (HB) value) and use of digital health applications (DiGA) apps for MS participants with fatigue (not applicable for participants in Switzerland), as available, are recorded at each infusion. _____ Previous interventions: The treatment follows the Summary of Product Characteristics (SmPC). The initial dose of 600 mg ocrelizumab (Ocrevus®) is given as two separate intravenous infusions; a first infusion of 300 mg followed by a second infusion of 300 mg given 2 weeks later. Follow-up doses of ocrelizumab are given as single intravenous infusions of 600 mg every 6 months. The first 600 mg follow-up dose should be given 6 months after the first infusion of the initial dose. During the 24-month observation period, patients will be assessed at the screening visit (V0) and during visits performed at month 0 (baseline, V1), around month 6 (V2), around month 12 (V3), around month 18 (V4) and around month 24 (V5, final) corresponding to routine clinical practice. Screening and baseline assessments can be performed on the same day as the first initial dose of ocrelizumab is given. Collection of Patient-Reported Outcomes (PROs) is based on the completion of questionnaires and scales by the patients using the electronic PRO system. The usage of PROs is considered non-interventional according to local regulations. “Trait fatigue” is measured at the first initial ocrelizumab infusion (baseline) and at the other visits with ocrelizumab infusion using the Fatigue Scale for Motor and Cognitive Functions (FSMC) (five assessments of “trait fatigue” expected per patient in the whole observation period). “State fatigue” is assessed by Visual Analogue Scale (VAS) three times at each visit with ocrelizumab infusion, once before, once after premedication, and once after ocrelizumab infusion. Additionally, “state fatigue” is analyzed using the electronic PRO 2 days after infusion and 3 months after each infusion visit. At month 24, the last “state fatigue” assessment is performed 2 days after infusion (24 assessments of “state fatigue” expected per patient in the observation period). PROs are recorded at the first initial dose and the four infusion visits (V2-V5, five assessments expected per patient in the observation period). Collection of PROs include completion of the questionnaires/scales Multiple Sclerosis Impact Scale (MSIS-29), Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS), Hospital Anxiety and Depression Scale (HADS), and Perceived Deficits Questionnaire (PDQ-20). Further parameters, such as Expanded Disability Status Scale (EDSS), MS relapses, change of MS treatment, employment status, physical fitness, health condition (e.g., smoking habit), premedication (e.g., type of antihistamine), laboratory values (e.g., ferritin, Hemoglobin (HB) value) and use of digital health applications (DiGA) apps for MS patients with fatigue as available, are recorded at each infusion. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ocrelizumab |
| Primary outcome measure | Current primary outcome measure as of 28/11/2024: "Trait fatigue" in RMS participants treated for the first time with ocrelizumab measured using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months _____ Previous primary outcome measure as of 20/12/2023: "Trait fatigue" in relapsed multiple sclerosis (RMS) participants treated for the first time with ocrelizumab measured using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months _____ Previous primary outcome measure: "Trait fatigue" in relapsed multiple sclerosis (RMS) patients treated for the first time with ocrelizumab measured using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months |
| Secondary outcome measures | Current secondary outcome measures as of 28/11/2024: 1. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab, measured by the FSMC cognitive score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 2. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab, measured by the FSMC motor score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 3. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥9 points using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 4. Change in “State fatigue” from before to during and after the treatment with ocrelizumab in participants with RMS measured by VAS over a time of 24 months observation period 5. Quality of life assessed using MSIS-29 at baseline and over the 24-month observation period 6. Working productivity and activity assessed using WPAI:MS at baseline and over the 24-month observation period 7. Depression assessed using HADS at baseline and over the 24-month observation period 8. Cognition assessed using PDQ-20 at baseline and over the 24-month observation period 9. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with PROs( MSIS-29, WPAI:MS, HADS, PDQ-20) analyzed using Pearson or Spearman correlation coefficients over the 24-month observation period. 10. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with non-serious adverse events (nsAEs), serious adverse events (SAEs) and adverse events of special interests (AESIs) that occurred during fatigue measurement assessed by PROs over the 24-month observation period 15. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with EDSS over the 24-month observation period _____ Previous secondary outcome measures as of 20/12/2023: 1. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab, measured by the FSMC cognitive score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 2. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab, measured by the FSMC motor score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 3. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥9 points using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 4. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥5 points using the FSMC cognitive score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 5. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥4 points using the FSMC motor score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 6. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab with a stabilization (=0 points) or reduction (of >0 points) using the FSMC total score, cognitive score and motor score, respectively, at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 7. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab measured using the FSMC total score, cognitive score and motor score, respectively, at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 12 months 8. “State fatigue” absolute change in RMS participants from baseline (before premedication) by visit, to after premedication, after ocrelizumab infusion, 2 days post-infusion and 3 months post infusions, measured by a Visual Analogue scale (VAS) and infusion time (2 h/2.5 h/3.5 h) will be presented for each ocrelizumab infusion. 9. Quality of life assessed using MSIS-29 at baseline and over the 24-month observation period 10. Working productivity and activity assessed using WPAI:MS at baseline and over the 24-month observation period 11. Depression assessed using HADS at baseline and over the 24-month observation period 12. Cognition assessed using PDQ-20 at baseline and over the 24-month observation period 13. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with PROs( MSIS-29, WPAI:MS, HADS, PDQ-20) analyzed using Pearson or Spearman correlation coefficients over the 24-month observation period. 14. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with adverse events (AEs) that occurred during fatigue measurement assessed by PROs over the 24-month observation period 15. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with EDSS over the 24-month observation period _____ Previous secondary outcome measures as of 21/09/2022 to 20/12/2023: 1. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab, measured by the FSMC cognitive score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 2. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab, measured by the FSMC motor score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 3. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥9 points using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 4. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥5 points using the FSMC cognitive score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 5. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥4 points using the FSMC motor score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 6. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab with a stabilization (=0 points) or reduction (of >0 points) using the FSMC total score, cognitive score and motor score, respectively, at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 7. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab measured using the FSMC total score, cognitive score and motor score, respectively, at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 12 months 8. “State fatigue” absolute change in RMS patients from baseline (before premedication) by visit, to after premedication, after ocrelizumab infusion, 2 days post-infusion and 3 months post infusions, measured by a Visual Analogue scale (VAS) and infusion time (2 h/2.5 h/3.5 h) will be presented for each ocrelizumab infusion. 9. Quality of life assessed using MSIS-29 at baseline and over the 24-month observation period 10. Working productivity and activity assessed using WPAI:MS at baseline and over the 24-month observation period 11. Depression assessed using HADS at baseline and over the 24-month observation period 12. Cognition assessed using PDQ-20 at baseline and over the 24-month observation period _____ Previous secondary outcome measures: 1. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab, measured by the FSMC cognitive score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 2. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab, measured by the FSMC motor score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 3. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥9 points using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 4. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥5 points using the FSMC cognitive score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 5. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab with a clinically meaningful reduction of ≥4 points using the FSMC motor score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 6. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab with a stabilization (=0 points) or reduction (of >0 points) using the FSMC total score, cognitive score and motor score, respectively, at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 7. “Trait fatigue” in RMS patients treated for the first time with ocrelizumab measured using the FSMC total score, cognitive score and motor score, respectively, at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 12 months 8. “State fatigue” absolute change in RMS patients from baseline (before premedication) by visit, to after premedication, after ocrelizumab infusion, 2 days post-infusion and 3 months post infusions, measured by a Visual Analogue scale (VAS) and infusion time (2 h/2.5 h/3.5 h) will be presented for each ocrelizumab infusion. |
| Overall study start date | 03/11/2020 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 272 |
| Key inclusion criteria | Current inclusion criteria as of 03/12/2024: 1. Diagnosis of MS 2. RMS participants, diagnosed by revised McDonald criteria 3. First-time treatment during the course of MS therapy with ocrelizumab according to the local label, regardless of the reason for starting treatment with ocrelizumab (participants may switch to the shorter IV infusion or SC injection within the study) _____ Previous inclusion criteria: 1. Diagnosis of MS 2. RMS patients, diagnosed by revised McDonald criteria 3. First-time treatment during the course of MS therapy with ocrelizumab according to the local label, regardless of the reason for starting treatment with ocrelizumab (patients may switch to the shorter infusion within the study) |
| Key exclusion criteria | 1. Off-label use of ocrelizumab 2. Participation in interventional studies investigating disease-modifying therapies for MS or in NIS Confidence (ML39632) 3. Severe psychiatric disability 4. Previous treatment with anti-CD20 antibodies 5. Pregnant and/or breastfeeding |
| Date of first enrolment | 28/12/2021 |
| Date of final enrolment | 18/06/2024 |
Locations
Countries of recruitment
- Germany
- Switzerland
Study participating centres
Ulm
89073
Germany
61348
Germany
Berlin
10437
Germany
09117
Germany
01307
Germany
45257
Germany
79106
Germany
22179
Germany
89518
Germany
07747
Germany
86633
Germany
75172
Germany
42853
Germany
68723
Germany
71065
Germany
78224
Germany
70174
Germany
82008
Germany
16761
Germany
97080
Germany
68163
Germany
07548
Germany
52074
Germany
65929
Germany
85540
Germany
12163
Germany
63739
Germany
70182
Germany
14471
Germany
53111
Germany
72076
Germany
68167
Germany
60528
Germany
81675
Germany
28235
Germany
44534
Germany
35043
Germany
3010
Switzerland
6004
Switzerland
Sponsor information
Industry
Emil-Barell-Straße 1
Grenzach-Wyhlen
79639
Germany
| Phone | +49 (0)7624 14 2224 |
|---|---|
| grenzach.study-management@roche.com | |
"ROR" |
https://ror.org/00sh68184 |
Industry
Gartenstrasse 9
Basel
4052
Switzerland
| Phone | +41 (0)61 715 44 88 |
|---|---|
| switzerland.clinical-research@roche.com | |
| Website | http://www.roche.ch/en/index.htm |
|
"ROR" |
https://ror.org/00by1q217 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Poster at DGN Congress, 3-6 November 2021 2. Abstract at European Committee for Treatment & Research in Multiple Sclerosis - 38th Congress, 13-15 October 2022 3. Abstract at European Charcot Foundation - 2022 Annual Meeting, 14-18 November 2022 |
| IPD sharing plan | Raw data for this study is not expected to be available; there is no regulatory requirement. |
Editorial Notes
03/12/2024: The inclusion criteria were changed.
28/11/2024: The following changes were made to the trial record:
1. The contact address was changed.
2. The overall end date was changed from 31/03/2026 to 30/06/2026.
3. The interventions were changed.
4. The primary outcome measure was changed.
5. The secondary outcome measures were changed.
6. The inclusion criteria were changed.
7. The target number of participants was changed from 740 to 272.
8. The recruitment end date was changed from 31/03/2024 to 18/06/2024.
9. The study participating centres Neurologie am Mexikoplatz, Nervenärztliche Gemeinschaftspraxis - Medicum Gesundheitszentrum Flugfeld, Neurologische Praxis Hagen, Universitaetsklinikum Marburg; Klinik fuer Neurologie, Katholisches Klinikum Lünen/Werne GmbH; Neurologische Klinik, Max Deist und Michael Ernst Sinsheim, Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie, Neuropraxis München Süd, Praxis für Neurologie Albrecht, Nervenarztpraxis Gerresheim, Oberhavel Kliniken, Ambulantes MS Zentrum Hennigsdorf, Universitätsklinikum Würzburg Neurologie, Klinikum Bayreuth GmbH, Klinik Hohe Warte, ZNS Südpfalz Zentrum für Nervensystem und Seele Rülzheim, Neuroplus, Medizinisches Versorgungszentrum, Inselspital Bern Medizin Neurologie; Neurologische Poliklinik, Luzerner Kantonsspital Luzern Medizin Neurologie were removed and Universitaetsklinikum Marburg; Klinik fuer Neurologie, Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie, Neuropraxis München Süd, Oberhavel Kliniken, Ambulantes MS Zentrum Hennigsdorf, Universitätsklinikum Würzburg Neurologie, Neuroplus, SRH Waldklinikum, Uniklinik RWTH Aachen, Klinikum Frankfurt Hochst GmbH, Kbo-Isar amper-Klinikum, Gemeinschaftspraxis Dr. med. Reinhard Ehret/Dr. med Wolfram von Pannwitz, Neuropraxis im Stadtpalais Dres. Ulzheimer/Herroder/Wessig GbR, NeuroConcept AG C/O mind mvz GmbH, St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH, Gesundheitszentrum St. Johannes Hospital, Universitätsklinikum Tübingen, Zentrum fur Neurologie, Universitätsklinikum Mannheim, Universitäetsklinikum Frankfurt, Praxis fur Neurologie und Psychiatrie am Prinzregentenplatz, Gesundheit Nord, Klinikum Bremen-Ost, Katholisches Klinikum Lünen/Werne GmbH; Neurologische Klinik, Universitaetsklinikum Marburg; Klinik fuer Neurologie were added.
10. The plain English summary was updated to reflect these changes.
11. The intention to publish date was changed from 28/12/2026 to 30/06/2027.
20/12/2023: The following changes were made to the trial record:
1. The public title was changed from "Impact of ocrelizumab on patient-reported fatigue and quality of life in patients with relapsing multiple sclerosis treated for the first time with ocrelizumab" to "Impact of ocrelizumab on patient-reported fatigue and quality of life in participants with relapsing multiple sclerosis treated for the first time with ocrelizumab".
2. The overall study end date was changed from 28/12/2025 to 31/03/2026.
3. The interventions were changed.
4. Dose response was added as a pharmaceutical study type.
5. The primary outcome measure was changed.
6. The secondary outcome measures were changed.
7. The recruitment end date was changed from 28/12/2023 to 31/03/2024.
8. Scientific and PI contacts added.
04/12/2023: The study contact was updated.
21/09/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 15/10/2021 to 28/12/2021.
2. The recruitment end date was changed from 15/10/2023 to 28/12/2023.
3. The overall trial end date was changed from 15/10/2025 to 28/12/2025.
4. The intention to publish date was changed from 15/10/2026 to 28/12/2026.
5. The secondary outcome measures were updated.
6. MVZ Dres. Schöll/Steidl & Kollegen GbR, Neurologie am Mexikoplatz, Neurologie Prenzlauer Berg, Nervenärztliche Gemeinschaftspraxis - Medicum Gesundheitszentrum Flugfeld, Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov, Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften, Praxis Nervenstark; Essen-Kupferdreh, Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie, Neurologische Praxis Hagen, MultipEL Studies - Institut für klinische Studien, Neurologische Gemeinschaftspraxis, Universitätsklinikum Jena, Klinik für Neurologie, Katholisches Klinikum Lünen/Werne GmbH; Neurologische Klinik, Universitaetsklinikum Marburg; Klinik fuer Neurologie, Praxis Dr. med. Bergmann, Facharztpraxis für Neurologie und Psychiatrie Dres Mattes/Stockert, Praxis Dr. Stienker-Fisse, Neurologische Praxis Dr. Wagner, Klinikum Sindelfingen-Böblingen; Klinik für Neurologie, EMSA - Zentrum für Neurologie/Psychiatrie/Neuroradiologie, Praxis Dr. med. Max Deist und Michael Ernst Sinsheim, Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie, Neuropraxis München Süd, Praxis für Neurologie Albrecht, Nervenarztpraxis Gerresheim, Oberhavel Kliniken, Ambulantes MS Zentrum Hennigsdorf, Universitätsklinikum Würzburg Neurologie, Klinikum Bayreuth GmbH, Klinik Hohe Warte, ZNS Südpfalz Zentrum für Nervensystem und Seele Rülzheim, Neuroplus, Medizinisches Versorgungszentrum, Inselspital Bern Medizin Neurologie; Neurologische Poliklinik, Luzerner Kantonsspital Luzern Medizin Neurologie were added as trial participating centres.
22/10/2021: Trial's existence confirmed by the Ethics Board of the State Medical Council of Baden-Württemberg.
