Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change (EPOC)
2015년 6월 18일 업데이트: 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).
연구 개요
연구 유형
중재적
등록 (실제)
61
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Novara, 이탈리아, 28100
- Novartis Investigative Site
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AN
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Ancona, AN, 이탈리아, 60126
- Novartis Investigative Site
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BI
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Ponderano, BI, 이탈리아, 13900
- Novartis Investigative Site
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CL
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Caltanissetta, CL, 이탈리아, 93100
- Novartis Investigative Site
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CN
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Cuneo, CN, 이탈리아, 12100
- Novartis Investigative Site
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CO
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Como, CO, 이탈리아, 22100
- Novartis Investigative Site
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CT
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Catania, CT, 이탈리아, 95122
- Novartis Investigative Site
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FG
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Foggia, FG, 이탈리아, 71100
- Novartis Investigative Site
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FI
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Castelfiorentino, FI, 이탈리아, 50051
- Novartis Investigative Site
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MI
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Milano, MI, 이탈리아, 20133
- Novartis Investigative Site
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Milano, MI, 이탈리아, 20122
- Novartis Investigative Site
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San Donato Milanese, MI, 이탈리아, 20097
- Novartis Investigative Site
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MO
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Modena, MO, 이탈리아, 41100
- Novartis Investigative Site
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PA
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Palermo, PA, 이탈리아, 90146
- Novartis Investigative Site
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Palermo, PA, 이탈리아, 90129
- Novartis Investigative Site
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PI
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Pisa, PI, 이탈리아, 56126
- Novartis Investigative Site
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VR
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Legnago, VR, 이탈리아, 37045
- Novartis Investigative Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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/일 경구 캡슐
다른 이름들:
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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Patient-reported Treatment Satisfaction
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Patient-reported Activities of Daily Living (ADL)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Renato Turrini, MD, Novartis Farma S.p.A.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 5월 1일
기본 완료 (실제)
2014년 6월 1일
연구 완료 (실제)
2014년 6월 1일
연구 등록 날짜
최초 제출
2011년 3월 15일
QC 기준을 충족하는 최초 제출
2011년 3월 15일
처음 게시됨 (추정)
2011년 3월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 6월 18일
마지막으로 확인됨
2015년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CFTY720DIT02
- 2010-024017-31 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .