Observational Study of Golimumab Intravenous Infusion (GO-IV)
2016년 11월 16일 업데이트: Janssen Inc.
Golimumab Intravenous Infusion Registry (GO-IV)
The purpose of this study is to evaluate the incidence and management of infusion reactions with Golimumab intravenous infusion.
연구 개요
상세 설명
This is a prospective, observational, non-interventional (no treatment given during course of the study) multi-center (when more than one hospital or medical school team work on a medical research study), study that will enroll participants with rheumatoid arthritis (RA) in Canada.
Only data available from source documentation will be collected.
The participation in this study will not impact on the standard of care of the participant or any benefits to which they are otherwise entitled.
All aspects of treatment decisions and clinical management of participants will be in accordance with clinical practice and at the discretion of the health care provider.
Participants' safety will be monitored throughout the study.
연구 유형
관찰
등록 (실제)
78
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Victoria, 캐나다
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Newfoundland and Labrador
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Saint-John'S, Newfoundland and Labrador, 캐나다
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Ontario
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Ancaster, Ontario, 캐나다
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Barrie, Ontario, 캐나다
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Kitchener, Ontario, 캐나다
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Mississauga, Ontario, 캐나다
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Nepean, Ontario, 캐나다
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Oakville, Ontario, 캐나다
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St.Catharines, Ontario, 캐나다
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Toronto, Ontario, 캐나다
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Quebec
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Laval, Quebec, 캐나다
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Montreal, Quebec, 캐나다
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다
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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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Canadian participants with rheumatoid arthritis (RA), who have been prescribed intravenous golimumab prior to, and independently of, study enrollment.
설명
Inclusion Criteria:
- Participants must have a confirmed diagnosis of rheumatoid arthritis
- Participants must have provided a written consent for data collection by signing an informed consent form indicating that he/she understand the purpose and procedures for data collection and are willing to participate in the study
- Participants are golimumab-naive (never have used golimumab both SC and IV formulations)
- Participants are prescribed golimumab intravenous by an appropriate physician as per the Canadian Product Monograph
Exclusion criteria:
- Participant who has been treated with golimumab in the past
- Participant has been diagnosed with psoriatic arthritis or ankylosing spondylitis
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point
- Participant is currently enrolled in an interventional study
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 |
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Golimumab Intravenous
Participants with rheumatoid arthritis (RA) in Canada, will be observed for 24 months.
Only data available from source documentation will be collected.
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This is a non-interventional study.
Participants with rheumatoid arthritis in Canada will be observed for 24 months.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Infusion Reactions
기간: Up to end of study (2 years) or early withdrawal
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The count of infusion reactions will be reported.
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Up to end of study (2 years) or early withdrawal
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With use of Pre-infusion Medications
기간: Baseline up to end of study (2 years) or early withdrawal
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Participants with administration of Pre-infusion medications or combination of Pre-infusion medications will be reported.
The list of pre-treatments includes: acetaminophen, anti-histamines, steroids (Hydrocortisone, Prednisone), acetaminophen alone, anti-histamines alone, steroids alone, steroids + anti-histamines, steroids + acetaminophen, anti-histamines + acetaminophen, steroids + anti-histamines + acetaminophen.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With use of Concomitant Medications at Time of Infusion
기간: Baseline up to end of study (2 years) or early withdrawal
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Participants with type of concomitant medications used at time of infusion will be reported.
The groups of concomitant medication of interest are: any immunosuppressant (IS), methotrexate and corticosteroids.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With Infusion Reaction Treatments
기간: Baseline up to end of study (2 years) or early withdrawal
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For each infusion administration with infusion reactions, type of medications was used to treat the reaction will be reported.
The list of medications includes anti-histamines, steroids, and epinephrine.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With Subsequent Reactions After the First Infusion Reaction
기간: Baseline up to end of study (2 years) or early withdrawal
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For each participant who has experienced at least 1 infusion reaction after enrolment, occurrence of infusion reaction at subsequent infusions after the first infusion reaction will be assessed.
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Baseline up to end of study (2 years) or early withdrawal
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Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score
기간: Baseline up to end of study (2 years) or early withdrawal
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The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping).
Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale.
Each domain also has a specific weight assigned by a patient survey.
The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).
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Baseline up to end of study (2 years) or early withdrawal
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Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score
기간: Baseline up to end of study (2 years) or early withdrawal
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The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping).
Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale.
Each domain also has a specific weight assigned by a patient survey.
The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).
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Baseline up to end of study (2 years) or early withdrawal
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Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score
기간: Baseline up to end of study (2 years) or early withdrawal
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The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping).
Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale.
Each domain also has a specific weight assigned by a patient survey.
The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).
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Baseline up to end of study (2 years) or early withdrawal
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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
2015년 2월 1일
기본 완료 (실제)
2016년 10월 1일
연구 완료 (실제)
2016년 10월 1일
연구 등록 날짜
최초 제출
2015년 3월 11일
QC 기준을 충족하는 최초 제출
2015년 3월 11일
처음 게시됨 (추정)
2015년 3월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 11월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 11월 16일
마지막으로 확인됨
2016년 11월 1일
추가 정보
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