A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) and Oral Treatments (Teriflunomide, Dimethyl Fumarate and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 141
- 主要终点
- Proportion of patients who continue to receive their baseline treatment
研究概览
简要总结
This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany.
Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.
详细描述
The prerequisite for participation in this observational study is the independent decision of the treating physician and patient to start an approved injectable or oral DMT for RMS as routine medical treatment. This decision must have been made prior to enrollment in this study.
Cohort 1: The prospective observational period per patient in the core part will be up to approx. two years from the time of consent (2 years +2 months visit window). If a patient re-consents to the extension part, then the prospective extension observational period will be additional approx. two years, resulting in a total observational period (prospectively for the core and extension part & retrospectively for the potential gap between core and extension part) of approx. 4 years (+ 2 month visit window).
Cohort 2: The prospective observational period per patient will be up to approx. two years from the time of consent (2 years + 2 months visit window).
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1 Inclusion Criteria:
- •Signed informed consent must be obtained prior to participation in the study
- •Male or female patients aged ≥18 years at enrollment
- •Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
- •RMS with active disease as defined by Lublin et al. (2014)
- •Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
- •Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
- •Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment
- •Cohort 2 Inclusion Criteria:
- •Signed informed consent must be obtained prior to participation,
- •Male or female patients aged ≥18 years at enrollment,
- •Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),
- •RMS with active disease as defined by Lublin et al. (2014) ,
- •Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment,
- •Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive),
- •Planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment:
- •Ofatumumab: only naïve patients or patients previously treated with max. one DMT other than ofatumumab
- •IFN-β1, GA, teriflunomide, DMF or DRF: only naïve patients
排除标准
- •Patients being treated outside of the approved label
- •> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
- •Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7)
- •Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy
- •Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
- •EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
- •Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab
- •Cohort 2 Exclusion Criteria:
- •Patients being treated outside of the approved label,
- •>5 years since first symptom(s) (leading to MS diagnosis) at enrollment,
- •Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,
- •Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2
研究组 & 干预措施
Ofatumumab
Patients treated with ofatumumab
干预措施: ofatumumab (Other)
Standard of Care (SoC)
Patients treated with either interferon β1 (IFN-β1), glatiramer acetate (GA), teriflunomide, dimethyl fumarate (DMF) or diroximel fumarate (DRF)
干预措施: interferon β1 (Other)
Standard of Care (SoC)
Patients treated with either interferon β1 (IFN-β1), glatiramer acetate (GA), teriflunomide, dimethyl fumarate (DMF) or diroximel fumarate (DRF)
干预措施: dimethyl fumarate (DMF) (Other)
Standard of Care (SoC)
Patients treated with either interferon β1 (IFN-β1), glatiramer acetate (GA), teriflunomide, dimethyl fumarate (DMF) or diroximel fumarate (DRF)
干预措施: diroximel fumarate (DRF) (Other)
Standard of Care (SoC)
Patients treated with either interferon β1 (IFN-β1), glatiramer acetate (GA), teriflunomide, dimethyl fumarate (DMF) or diroximel fumarate (DRF)
干预措施: glatiramer acetate (Other)
Standard of Care (SoC)
Patients treated with either interferon β1 (IFN-β1), glatiramer acetate (GA), teriflunomide, dimethyl fumarate (DMF) or diroximel fumarate (DRF)
干预措施: teriflunomide (Other)
结局指标
主要结局
Proportion of patients who continue to receive their baseline treatment
时间窗: Month 24
Proportion of patients who continue to receive their baseline treatment \[ofatumumab or other approved disease modifying therapies (IFN-β1, GA, teriflunomide, DMF or DRF)\]
次要结局
- Time to onset of confirmed disability improvement (CDI)(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
- Annualized T2 lesion rate(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
- Proportion of patients with no evidence of disease activity (NEDA3) upon discretion of the investigator.(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
- Proportion of patients with no clinical disease activity and no discontinuation of current treatment due to AEs(Up to 24 months)
- Number of patients with treatment interruptions(Up to 24 months)
- Persistence of drug-related adverse events (AEs)(Up to 24 months)
- Impact of first-line treatment on health economy(Baseline, month 6, month 12, month 18 and month 24)
- T1 Gd-enhancing lesions per brain(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
- Fatigue Symptoms and Impact Questionnaire-RMS(Baseline, month 3, month 6, month 12, month 18, month 24)
- Generalized Anxiety Disorder Scale 7 [GAD-7](Baseline, month 3, month 6, month 12, month 18, month 24)
- Expanded disability status scale (EDSS)(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
- Patient Health Questionnaire 8 [PHQ-8](Baseline, month 3, month 6, month 12, month 18, month 24)
- Proportion of patients with CDI(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
- MS Treatment Concerns Questionnaire [MSTCQ](Baseline, month 3, month 6, month 12, month 18, month 24)
- Annualized relapse rate(Up to 24 months)
- Time to first relapse(Up to 24 months)
- Proportion of relapse free patients(Up to 24 months)
- Number of patients and reasons for discontinuation of treatment(Up to 24 months)
- Duration of treatment interruptions per patient(Up to 24 months)
- Proportion of drug-related adverse events (AEs)(Up to 24 months)
- Specific safety assessment of injection related AEs(Up to 24 months)
- Presence of spinal cord lesions(Baseline, month 3,month 6, month 9, month 12, month 15, month 18, month 21, month24)
- Reasons for and number of treatment interruptions per patient(Up to 24 months)
- Proportion of participants discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons(Up to 24 months)
- Age of male and female participants(Baseline)
- Proportion of patients who continue to receive their subsequent treatment(Up to 24 months)
- Proportion of patients who continue to receive their baseline treatment(Month 12)
- Time to event analysis for retention time on baseline treatment(From Baseline to event, up to 24 months)
- Number of previous MS relapses of male and female participants(Baseline)
- Multiple Sclerosis Impact Scale 29 v2(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24)
- Quality of Life in Neurological Disorders [NeuroQoL](Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24)
- Time to onset of confirmed disability worsening (CDW)(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
- Proportion of patients with confirmed disability worsening (CDW)(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
- Serum NfL levels(Baseline, month 6, month 12, month 18 and month 24)
- Proportion of patients with low or elevated sNfL levels(Baseline, month 6, month 12, month 18 and month 24)
- Association of selected effectiveness and PRO outcomes with sNfL levels(Baseline, month 6, month 12, month 18 and month 24)
- Reasons for treatment decisions(Up to 24 months)
- Proportion of sites that share the standardized MRI report form with their radiological colleagues(Baseline, month 6, month 12, month 18 and month 24)
- Proportion of standardized MRI report forms and conventional radiologists' reports(Baseline, month 6, month 12, month 18 and month 24)
- Serum NfL levels of male and female patients(Baseline, month 6, month 12, month 18 and month 24)
- Effect of standardized MRI report form on completeness of lesion documentation(Baseline, month 6, month 12,1 month 8 and month 24)
- Physician's view on added value of standardized MRI report form over conventional radiologists' reports(Baseline, month 6, month 12, month 18 and month 24)
- Proportion of patients and physicians that intend to view and use PRO and sNfL results to support patient-physician dialogue(Month 6,month 12, month 18 and month 24)
- Proportion of patients that access their PRO and sNfL result visualizations at least once every 6 months(Month 6,month 12, month 18 and month 24)
- Perceived value of PRO and sNfL result visualizations from the perspective of both patient and treating physician on patient-physician dialogue and shared decision making(Month 6,month 12, month 18 and month 24)
- Proportion of male and female patients who continue to receive their baseline treatment(Month 12, Month 24)
- Annualized relapse rate of male and female patients(Up to 24 months)
- Reasons for treatment decisions of male and female patients(Up to 24 months)
- Quality of Life in Neurological Disorders [NeuroQoL] of male and female patients(Baseline, month 3, month 6, month 9, month 12, month15, month 18, month 21 and month 24)