- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01958827
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 3단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject ≥ 15 years of age at the time of informed consent.
- Subject with Crohn's disease who received induction treatment of commercially available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira®.
- Subject with elevated C-reactive Protein (CRP) at Screening.
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug.
- Subject has a negative tuberculosis (TB) screening assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.
Exclusion Criteria:
- Subject with suspicion of colitis other than Crohn's disease.
- Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
- Subject with abscess or suspicion of abscess, or subject with infection(s).
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 |
---|---|
실험적: Adalimumab 80 mg
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
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피하 주사로 투여되는 Adalimumab 프리필드 시린지.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
기간: Week 8
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CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
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Week 8
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
기간: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
기간: Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
Week 8 was the primary outcome measure.
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Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
기간: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
기간: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
|
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease.
A score below 150 indicates remission and a score above 450 indicates severe disease.
Non-responder imputation (NRI) for missing CDAI observations was used.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
기간: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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C-reactive protein (CRP) was measured from blood samples as a marker for inflammation.
Higher levels are indicative of more inflammation.
Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age.
Last Observation Carried Forward (LOCF) was used for missing data.
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Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Number of Participants With Potentially Significant Hematology Parameters
기간: 52 weeks
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Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory.
The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.
Increase is signified by ↑. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value.
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52 weeks
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Number of Participants With Potentially Significant Clinical Chemistry Parameters
기간: 52 weeks
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Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory.
The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.
n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.
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52 weeks
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Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
기간: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Blood pressure was measured while the participant was sitting.
n=the number of participants with available data at each time point.
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
기간: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Blood pressure was measured while the participant was sitting.
n=the number of participants with available data at each time point.
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
기간: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Heart rate was measured while the participant was sitting.
n=the number of participants with available data at each time point.
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
기간: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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n=the number of participants with available data at each time point.
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Number of Participants With Adverse Events (AEs)
기간: 60 weeks
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An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below. |
60 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
기간: Baseline (Week 0) to Week 52
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Blood samples were drawn prior to drug administration.
Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method.
The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha.
n=the number of participants with available data at each time point.
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Baseline (Week 0) to Week 52
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Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52
기간: Baseline (Week 0) to Week 52
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Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses.
Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL.
A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.
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Baseline (Week 0) to Week 52
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Morio Ozawa, MS, AbbVie GK.
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
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