Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Upland, California, 미국, 91786
- Inland Rheumatology Clinical Trials, Inc.
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Florida
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Venice, Florida, 미국, 34292
- Lovelace Scientific Resources, Incorporated
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Maryland
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Cumberland, Maryland, 미국, 21502
- Klein and Associates, M.D., P.A.
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Massachusetts
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Worcester, Massachusetts, 미국, 01605
- Clinical Pharmacology Study Group
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New Mexico
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Albuquerque, New Mexico, 미국, 87102
- Albuquerque Center for Rheumatology
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Texas
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Dallas, Texas, 미국, 75231
- Metroplex Clinical Research Center
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Houston, Texas, 미국, 77065
- Rheumatology Clinic of Houston, P.A.
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Lubbock, Texas, 미국, 79424
- Arthritis & Osteoporosis Associates LLP
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Nassau Bay, Texas, 미국, 77058
- Heartland Research Associates, LLC
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Bialystok, 폴란드, 15-099
- Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
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Bydgoszcz, 폴란드, 85-168
- Szpital Uniwersytecki nr 2 im.dr J. Biziela
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Elblag, 폴란드, 82-300
- Wojewodzki Szpital Zespolony w Elblagu
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Gdynia, 폴란드, 81-338
- Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
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Katowice, 폴란드, 40-954
- Medical Centre Pratia Katowice I
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Krakow, 폴란드, 30-002
- Medical Centre Pratia Krakow
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Krakow, 폴란드, 31-023
- Specialist Center ALL-MED, Krakow
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Torun, 폴란드, 87-100
- Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
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Warszawa, 폴란드, 01-868
- Medical Centre Pratia Warszawa
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Wroclaw, 폴란드, 51-128
- Wojewodzki Szpital Specjalistyczny We Wroclawiu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which is not adequately controlled by non-biologics DMARDs.
- No contraindications to anti-Tumor necrosis factor (TNF) agents.
- Either biologics naive or biologics-experienced but with no experience of self-administration medication using autoinjector or pen.
- Patients must be able and willing to self-inject BI 695501. Further inclusion criteria apply.
Exclusion criteria:
- Experience with self-administration of medication using an autoinjector or pen.
- American College of Rheumatology functional Class IV or wheelchair/ bed bound.
- Primary or secondary immunodeficiency.
- History of tuberculosis (TB). Further exclusion criteria apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: BI 695501
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections
기간: Up to Day 50.
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The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis. Percentage of injections calculated relative to the total number of first injections. |
Up to Day 50.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
기간: Up to Day 50.
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The percentage of any autoinjector handling event during the self-injection process included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c). Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful). |
Up to Day 50.
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Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
기간: Up to 17 weeks.
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Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period. Percentage of subjects calculated relative to the total number of subjects in the analysis set. |
Up to 17 weeks.
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Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
기간: Up to 17 weeks.
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A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication.
Data is reported for the autoinjector assessment period.
TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive.
The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included).
If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.
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Up to 17 weeks.
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Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
기간: up to Week 60
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The percentage of patients with local injection site reactions in the Autoinjector assessment period and Extension Phase.
In Extension phase, patients were given diaries to record events between each site visit during extension phase.
Patients were instructed to accurately record the following on the diary cards: the dates & times of BI 695501 dosing; problems encountered with dosing; the occurrence of any AEs; the use of concomitant therapies; and the PFS storage conditions.
Patients were instructed to contact the site if they experienced any AEs between designated site visits.
In Extension phase Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first PFS administration date (Day 57 visit) and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
Percentage of subjects calculated relative to the total number of subjects in the analysis set
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up to Week 60
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Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment
기간: up to Week 60
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The percentage of patients with drug-related adverse events as per investigator in the Autoinjector assessment period and Extension Phase.
In Extension phase, Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication and prior to the last date of trial medication during Extension phase treatment period + 10 weeks (70 days) inclusive.
The Extension phase treatment period started on the first PFS administration date (Day 57 visit) and ended on Day 351 visit date (included).
Thus If a TEAE occurred from the first PFS administration and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
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up to Week 60
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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관절염, 류마티스에 대한 임상 시험
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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
BI 695501 Autoinjector에 대한 임상 시험
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Boehringer Ingelheim완전한관절염, 류마티스미국, 스페인, 대한민국, 태국, 말레이시아, 폴란드, 러시아 연방, 세르비아, 불가리아, 칠레, 에스토니아, 독일, 헝가리, 우크라이나
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Boehringer Ingelheim완전한건선미국, 독일, 러시아 연방, 체코, 폴란드, 우크라이나, 에스토니아, 슬로바키아
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Boehringer Ingelheim완전한크론병세르비아, 영국, 미국, 체코, 독일, 그리스, 폴란드, 러시아 연방, 칠면조, 이스라엘, 벨라루스, 우크라이나, 크로아티아, 보스니아 헤르체고비나
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Boehringer Ingelheim완전한건선미국, 폴란드, 헝가리, 독일, 라트비아, 러시아 연방, 우크라이나
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Boehringer Ingelheim완전한관절염, 류마티스스페인, 미국, 대한민국, 말레이시아, 폴란드, 태국, 불가리아, 칠레, 에스토니아, 독일, 헝가리, 뉴질랜드, 러시아 연방, 세르비아, 우크라이나
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Merck Sharp & Dohme LLC완전한
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Boehringer Ingelheim완전한