Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change (EPOC)
2015年6月18日 更新者：Novartis Pharmaceuticals
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)
The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
調査の概要
研究の種類
介入
入学 (実際)
61
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Novara、イタリア、28100
- Novartis Investigative Site
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AN
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Ancona、AN、イタリア、60126
- Novartis Investigative Site
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BI
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Ponderano、BI、イタリア、13900
- Novartis Investigative Site
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CL
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Caltanissetta、CL、イタリア、93100
- Novartis Investigative Site
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CN
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Cuneo、CN、イタリア、12100
- Novartis Investigative Site
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CO
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Como、CO、イタリア、22100
- Novartis Investigative Site
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CT
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Catania、CT、イタリア、95122
- Novartis Investigative Site
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FG
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Foggia、FG、イタリア、71100
- Novartis Investigative Site
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FI
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Castelfiorentino、FI、イタリア、50051
- Novartis Investigative Site
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MI
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Milano、MI、イタリア、20133
- Novartis Investigative Site
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Milano、MI、イタリア、20122
- Novartis Investigative Site
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San Donato Milanese、MI、イタリア、20097
- Novartis Investigative Site
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MO
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Modena、MO、イタリア、41100
- Novartis Investigative Site
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PA
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Palermo、PA、イタリア、90146
- Novartis Investigative Site
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Palermo、PA、イタリア、90129
- Novartis Investigative Site
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PI
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Pisa、PI、イタリア、56126
- Novartis Investigative Site
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VR
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Legnago、VR、イタリア、37045
- Novartis Investigative Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
- Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
- An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
- Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
- Naïve to treatment with fingolimod.
Exclusion Criteria:
- A manifestation of MS other than those defined in the inclusion criteria.
- A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
- Diagnosis of macular edema during Screening Phase.
Other protocol-defined inclusion/exclusion criteria may apply
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Fingolimod
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
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0.5mg/日経口カプセル
他の名前：
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アクティブコンパレータ：Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
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Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Patient-reported Treatment Satisfaction
時間枠：baseline, 6 months
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The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication.
It consists of 3 subscales: effectiveness, convenience and global satisfaction.
The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction.
The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range.
The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction.
This provided a transformed score between 0 and 1 that was then multiplied by 100.
A positive change from baseline indicates improvement.
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baseline, 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Patient-reported Activities of Daily Living (ADL)
時間枠：baseline, 6 months
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The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living.
The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation.
A negative change from baseline indicates improvement.
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baseline, 6 months
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Change From Baseline in Patient-reported Fatigue
時間枠：6 months
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The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue.
The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)).
A negative change from baseline indicates improvement.
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6 months
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Change From Baseline in Patient-Reported Effectiveness and Convenience
時間枠：6 months
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The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication.
It consists of 3 subscales: effectiveness, convenience and global satisfaction.
The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction.
The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range.
The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction.
This provided a transformed score between 0 and 1 that was then multiplied by 100.
A positive change from baseline indicates improvement.
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6 months
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Change From Baseline in Patient-reported Depression
時間枠：6 months
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The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness.
The BDI-FS score was calculated summing the 7 items of the questionnaire.
Each item ranged from 0 (not present) to 3 (severe).
The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression).
A negative change from baseline indicates improvement.
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6 months
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Change From Baseline in Patient-reported Health Related Quality of Life (QOL)
時間枠：6 months
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The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS.
It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
If half or more questions within a domain were answered, then a score was calculated for that domain.
Otherwise, the patient score for that domain was set to missing.
If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing.
An algorithm was used to create a score from 0 to 100 for each domain score and component score.
A positive change from baseline indicates improvement.
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6 months
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Physician-reported Clinical Global Impression of Improvement (CGI-I)
時間枠：6 months
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The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time.
The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse.
A lower score and a negative change from baseline indicate improvement.
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6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Renato Turrini, MD、Novartis Farma S.p.A.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年5月1日
一次修了 (実際)
2014年6月1日
研究の完了 (実際)
2014年6月1日
試験登録日
最初に提出
2011年3月15日
QC基準を満たした最初の提出物
2011年3月15日
最初の投稿 (見積もり)
2011年3月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年6月22日
QC基準を満たした最後の更新が送信されました
2015年6月18日
最終確認日
2015年6月1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
- CFTY720DIT02
- 2010-024017-31 (EudraCT番号)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。