- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01320293
Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis
Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.
In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27516
- UNC Dermatology Clinical Trials Unit
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Must understand and voluntarily sign an informed consent form.
- Must be male or female and age 18-55 years at time of consent.
- Must be able to adhere to the study visit schedule and other protocol requirements
- Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.
- Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).
- Negative PPD at Screening or 3 months earlier.
- Have not used any biologic treatment for psoriasis in the past 12 months.
Exclusion Criteria:
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Pregnant, trying to become pregnant or breastfeeding
- Prior diagnosis of coronary artery disease (CAD) or heart disease.
- Systemic fungal infection
- History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
- History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
- Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
- Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
- History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C
- Positive Hepatitis B Surface antigen at screening
- Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening)
- History of any demyelinating disorder such as multiple sclerosis.
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: Adalimumab 40mg
Adalimumab 40 MG/0.8
ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months
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40mg subcutaneously, every other week for 6 months
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage Change in Endothelial Function Compared to Baseline.
기간: 6 months
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Percentage change in endothelial function between baseline visit and end of treatment, 6 months.
Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in IL-6 Profile Compared to Baseline
기간: 6 months
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IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.
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6 months
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Changes in Adiponectin Profile Compared to Baseline
기간: 24 weeks
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Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.
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24 weeks
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
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 연구와 관련된 용어
기타 연구 ID 번호
- ABBO-0001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .