Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis (SONATA-MS)
A Prospective Longitudinal Multicenter, Multi-Country, Observational Study Assessing Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Relapsing-Remitting Multiple Sclerosis (SONATA-MS)
The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-naive, switching from intravenous (i.v.) ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c. ocrelizumab.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究連絡先のバックアップ
- 名前：Reference Study ID Number: MN46738 https://forpatients.roche.com/ No attachments to email below.
- 電話番号：888-662-6728
- メール：global-roche-genentech-trials@gene.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The study population will consist of participants diagnosed with RRMS who are treated with ocrelizumab s.c. for the first time (initial treatment or treatment switch) as part of their multiple sclerosis (MS) therapy during routine clinical practice
説明
Inclusion Criteria:
- Diagnosis of RRMS according to the revised McDonald criteria (2017 or 2024 revisions).
- Initiation of ocrelizumab s.c in accordance with routine clinical practice and local prescribing information.
- The decision to initiate ocrelizumab s.c. has been made by the treating physician prior to and independently of study participation.
- Willingness to complete the patient-reported outcome questionnaire TASQ, where applicable.
Exclusion Criteria:
- Participation in any clinical study involving disease modifying therapies for multiple sclerosis during the study period or at the time of enrollment.
- Prior treatment with rituximab.
- Contraindications to ocrelizumab as per the local prescribing information.
- Severe psychiatric or cognitive impairment that, in the opinion of the treating physician, would preclude informed consent, reliable participation in the study, or completion of patient-reported outcomes.
- Any condition which, in the opinion of the treating physician, would interfere with participation in the study or the interpretation of study results.
- For participants participating in a Market Research and Patient Support Program (MAP), inclusion is permitted only when a cross-reference to the unique MAP patient identifier is available.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Cohort 1
Treatment-naive participants initiating ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c. |
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
他の名前：
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Cohort 2
Participants who were receiving ocrelizumab i.v. and then switched to ocrelizumab s.c., representing a change in route of administration as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c. |
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
他の名前：
|
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Cohort 3
Treatment experienced participants who were receiving prior DMTs and then switched to ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c. |
Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12
時間枠：At Month 12
|
At Month 12
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of Convenient / Very Convenient Responses on the TASQ Convenience Item Score at Month 12
時間枠：At Month 12
|
At Month 12
|
|
Change From Baseline in Serum Neurofilament Light Chain (NfL) at Months 6 and 12
時間枠：Baseline, Months 6 and 12
|
Baseline, Months 6 and 12
|
|
Annualized Relapse Rate (ARR) From Baseline to Month 12
時間枠：Baseline to Month 12
|
Baseline to Month 12
|
|
Proportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation
時間枠：Baseline to Month 12
|
Baseline to Month 12
|
|
Proportion of Participants Persistent on Treatment From Baseline Through Month 12
時間枠：Baseline to Month 12
|
Baseline to Month 12
|
|
Incidence, Severity and Outcomes of Adverse Events (AEs)
時間枠：Up to 2.6 years
|
Up to 2.6 years
|
|
Duration of AEs
時間枠：Up to 2.6 years
|
Up to 2.6 years
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Clinical Trials、Hoffmann-La Roche
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MN46738
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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