Comparing the Effectiveness of a Treat-to-target (T2T) Disease Management Strategy vs. Routine Care (RC) in Adult Patients With Moderate to Severe Rheumatoid Arthritis (RA) Treated With Subcutaneous Abatacept (Orencia - SC) (ABC)
2019년 1월 28일 업데이트: Bristol-Myers Squibb
The Abatacept Best Care (ABC) Trial
This is a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to participate in a 12-month extension of their follow-up provided that this is in agreement with the judgment of the treating physician.
연구 개요
연구 유형
관찰
등록 (실제)
281
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Quebec
-
Westmount, Quebec, 캐나다, H3Z 1R7
- Local Institution
-
-
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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Adult patients with active RA defined as a CDAI > 10 for whom the treating physician has made the decision to initiate treatment with SC abatacept according to the approved Canadian product monograph and regional reimbursement criteria will be potentially eligible for inclusion in the study.
The decision to treat the patient with SC abatacept must have been reached prior to and independently of considering the patient for study enrollment.
설명
Inclusion Criteria:
- 18 years of age or older.
- Active moderate to severe RA, defined as CDAI > 10.
- The treating physician has made the decision to initiate treatment with SC abatacept in accordance with the Canadian product monograph.
- Patient has provided a written informed consent and is able to complete the survey requirements.
- Patient fulfills the reimbursement criteria for treatment with SC abatacept under provincial or private health insurance reimbursement coverage.
Exclusion Criteria:
- Has received abatacept (SC or IV) prior to the enrolment visit.
- Has failed more than one prior biologic DMARD therapy
- Has a history of autoimmune disease or of any joint inflammatory disease other than RA with the exception of concomitant secondary Sjogren's syndrome.
- Is participating in an ongoing clinical trial and/or has received treatment with an investigational agent within 4 weeks before starting treatment with SC abatacept.
- Is participating in another industry-sponsored observational study.
- Patients participating to non-industry related registries or other data collection studies can be included
- Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of RA treatment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
|
비간섭
|
|
RC Patients
RA patients managed with routine care(RC)
|
비간섭
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of T2T patients achieving sustained CDAI LDA
기간: Approximately 1 year
|
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
|
Approximately 1 year
|
|
Number of RC patients achieving sustained CDAI LDA
기간: Approximately 1 year
|
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
|
Approximately 1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of patients achieving SDAI remission
기간: Up to 24 months
|
Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3
|
Up to 24 months
|
|
Mean time for patients to achieve SDAI remission
기간: Up to 24 months
|
Length of time from treatment initiation SDAI remission
|
Up to 24 months
|
|
Number of patients achieving CDAI remission
기간: Up to 24 months
|
Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8
|
Up to 24 months
|
|
Mean time for patients to achieve CDAI remission
기간: Up to 24 months
|
Length of time from treatment initiation CDAI remission
|
Up to 24 months
|
|
Number of patients achieving DAS28-CRP LDA
기간: Up to 24 months
|
Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2
|
Up to 24 months
|
|
Mean time for patients to achieve DAS28-CRP LDA
기간: Up to 24 months
|
Length of time from treatment initiation to a DAS28-CRP score of less than 3.2
|
Up to 24 months
|
|
Number of patients achieving DAS28-CRP remission
기간: Up to 24 months
|
Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6
|
Up to 24 months
|
|
Mean time for patients to achieve DAS28-CRP remission
기간: Up to 24 months
|
Length of time from treatment initiation to a DAS28-CRP score of less than 2.6
|
Up to 24 months
|
|
Number of patients achieving Boolean remission
기간: Up to 24 months
|
Boolean remission is defined as TJC28 ≤1 and SJC28 ≤1 and CRP ≤1 mg/dl and PtGA ≤1 (on a 0-10 scale)
|
Up to 24 months
|
|
Mean time for patients to achieve Boolean remission
기간: Up to 24 months
|
Length of time from treatment initiation to Boolean remission.
|
Up to 24 months
|
|
Number of patients achieving RAPID3 LDA
기간: Up to 24 months
|
Routine Assessment of Patient Index Data 3 (RAPID3) Low Disease Activity (LDA) is achieved when RAPID3 score is less than or equal to 6.
|
Up to 24 months
|
|
Mean time for patients to achieve RAPID3 LDA
기간: Up to 24 months
|
Length of time from treatment initiation to a RAPID3 score of less than or equal to 6
|
Up to 24 months
|
|
Number of patients achieving RAPID3 remission
기간: Up to 24 months
|
Routine Assessment of Patient Index Data 3 (RAPID3) remission is achieved when RAPID3 score is less than or equal to 3.
|
Up to 24 months
|
|
Mean time for patients to achieve RAPID3 remission
기간: Up to 24 months
|
Length of time from treatment initiation to a RAPID3 score of less than or equal to 3
|
Up to 24 months
|
|
Number of patients achieving MCID in HAQ-DI
기간: Up to 24 months
|
minimal clinically important difference (MCID; Δ ≥ 0.22, ≥0.25, and ≥0.5) in Health Assessment Questionnaire Disability Index (HAQ-DI)
|
Up to 24 months
|
|
Mean time for patients to achieve MCID in HAQ-DI
기간: Up to 24 months
|
Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI
|
Up to 24 months
|
|
Number of patients achieving clinically meaningful improvement
기간: Up to 24 months
|
Number of patients achieving clinically meaningful improvement as measured by a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
|
Up to 24 months
|
|
Mean time for patients to achieve clinically meaningful improvement
기간: Up to 24 months
|
Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
|
Up to 24 months
|
|
Number of patients achieving patient expectations for treatment of their RA
기간: Up to 24 months
|
Assessed using simple Visual Analogue Scales (VAS)
|
Up to 24 months
|
|
Change from baseline in DAS28-CRP score
기간: Baseline up to 24 months
|
Measured by investigator assessment
|
Baseline up to 24 months
|
|
Change from baseline in CDAI score
기간: Baseline up to 24 months
|
Measured by investigator assessment
|
Baseline up to 24 months
|
|
Change from baseline in SDAI score
기간: Baseline up to 24 months
|
Measured by investigator assessment
|
Baseline up to 24 months
|
|
Change from baseline in RAPID3 score
기간: Baseline up to 24 months
|
Measured by investigator assessment
|
Baseline up to 24 months
|
|
Change from baseline in Tender Joint Count of 28 joints (TJC28) score
기간: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
|
Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
기간: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
|
Change from baseline in HAQ-DI score
기간: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
|
Change from baseline in Work Productivity and Activity Impairment (WPAI) score
기간: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
|
Change from baseline in Patient Pain
기간: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
|
Change from baseline in Patient Fatigue
기간: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
|
Number of patients continuing treatment
기간: At 12 months
|
Measured by investigator assessment
|
At 12 months
|
|
Number of patients continuing treatment
기간: At 24 months
|
Measured by investigator assessment
|
At 24 months
|
|
Number of changes to Rheumatoid Arthritis (RA) treatment
기간: Up to 24 months
|
Measured by investigator assessment
|
Up to 24 months
|
|
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
기간: Up to 12 months
|
Measured by questionnaire
|
Up to 12 months
|
|
Incidence of treatment-emergent Adverse Events
기간: Up to 24 months
|
Measured by investigator assessment
|
Up to 24 months
|
|
Time to achieve sustained CDAI LDA
기간: Up to 12 Months
|
Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
|
Up to 12 Months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 (실제)
2011년 10월 31일
기본 완료 (실제)
2018년 10월 31일
연구 완료 (실제)
2018년 10월 31일
연구 등록 날짜
최초 제출
2017년 9월 5일
QC 기준을 충족하는 최초 제출
2017년 9월 5일
처음 게시됨 (실제)
2017년 9월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 1월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 1월 28일
마지막으로 확인됨
2019년 1월 1일
추가 정보
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. .
류마티스 관절염에 대한 임상 시험
-
Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
비간섭에 대한 임상 시험
-
University Hospital, Clermont-FerrandFondation Apicil알려지지 않은
-
Seeding IncMellitas Health Foods, LLC (DBA Layer Origin Nutrition)완전한
-
Andres Duque DuqueZimmer Biomet알려지지 않은
-
Biologics & Biosimilars Collective Intelligence...Merck Sharp & Dohme LLC; Pfizer; AbbVie; University of Pittsburgh; Boehringer Ingelheim; Kaiser... 그리고 다른 협력자들완전한류마티스 관절염 | 건선 | 건선성 관절염 | 염증성 장 질환 | 강직성 척추염