이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Danish Population-based Assessment of Psoriasis and Psoriatic Arthritis (DANPAPP) (DANPAPP)

2020년 8월 14일 업데이트: Professor Mikkel Østergaard

Prevalence, Pattern and Disease Course og Arthritis and Enthesitis in Patients With Psoriasis, and Effect of Apremilast in Subclinical, US-defined Psoriatic Arthritis - a Population Based Study Applying Clinical, Ultrasonic, MRI and Patient-reported Outcomes

3-part study of patients with psoriasis, including 1) a population based questionnaire 2) cross-sectional clinical study with focus on musculoskeletal ultrasound and patient reported outcomes 3) 12 months follow-up study of patients with certain ultrasonic signs of psoriatic arthritis. Patients with pain: Interventional with 6 months treatment with apremilast, followed by 6 months observation. Patients without pain: 12 months observation.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

Part 1:

A population-based survey of Danish inhabitants, will by screening of approximately 10.000 Danes identify approximately 425 persons who report to have psoriasis(PsO) with or without psoriatic arthritis (PsA). These will receive an e-mail invitation to an internet based questionnaire regarding demographics, skin and joint complaints, diagnosed diseases, contact to health care providers, and different aspect of psychological and physical function and wellbeing (incl. function, health-related quality of life, depression, anxiety, social participation, and sleep disturbances). In the questionnaire the participant will be asked if he/she would be interested in participating in a clinical study.

Part 2:

Participants who accept the above mentioned invitation (estimated 273) will be seen in a Department of Rheumatology, for the following examination programme: Clinical examination with a focus on skin, joints and entheses,ultrasonic (US) examination of joints and entheses, patient-reported outcomes and blood sampling for both stratification and identification of biochemical signs of inflammation.

Patients with musculoskeletal pain and certain joint and/or entheseal inflammation documented by US, will be invited to participate in a 12 months' interventional study (part 3a, below), whereas patients without musculoskeletal pain but with US findings (as above) will be invited to participate in a 12 months non-interventional follow-up study (part 3b, below). Patients with pre-diagnosed PsA that by US have active inflammation (same definition and criteria as above), will also be invited to participate in the interventional study if they fit the criteria, especially those described under concomitant medication, otherwise they will be offered to participate in the non-interventional study.

Part 3a:

Patients with musculoskeletal pain in relation to joints and/or entheses (that is not explained by alternative diagnosis, as assessed by including rheumatologist) and "US-defined PsA", i.e. with certain joint and/or entheseal inflammation as documented by US, will be offered inclusion in a 12 months' interventional study, in which 6 month induction therapy with apremilast (in addition to their usual therapy) will be followed by cessation of apremilast and 6 months of observation. Patients will be followed with clinical examination, PRO's, blood sampling and US at months 3, 6, 9 and 12.

MRI will be performed at inclusion and at 6 months follow-up in selected patients (patients with dactylitis or with enthesitis in the ankle region (Achilles enthesitis or plantar fasciitis)).

Part 3b:

Patients without musculoskeletal pain but with certain joint or entheseal inflammation verified by US will be offered inclusion in a 12 months' non-interventional study. Patients will continue their current therapy and be followed with clinical examination, patient-reported outcomes, blood sampling and US at months 3, 6, 9 and 12.

연구 유형

중재적

등록 (예상)

115

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 덴마크
      • Glostrup, 덴마크, 2600
        • Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup
      • Sønderborg, 덴마크, 6400
        • Dansk Gigthospital

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

설명

Inclusion Criteria:

In general (all parts of the study):

  • Age >18 years
  • Being able and willing to comply with the requirements of this protocol
  • Having signed informed consent

Part 2:

• Psoriasis, diagnosed by a physician according to patient

Part 3a:

  • Musculoskeletal pain in relation to joints or entheses (that is not explained by alternative diagnosis, as assessed by including rheumatologist) and"US-defined PsA" (ie. with certain joint and/or entheseal inflammation as documented by US (see 'Definitions of patient populations' for definition))

  • MRI substudy:

    • Clinical dactylitis or enthesitis in the ankle region (Achilles enthesitis or plantar fasciitis)
    • No contraindications for MRI (see appendix 22.2.2) For allowed and disallowed previous and concomitant treatment, please see paragraph on "Previous and concomitant medication".

Part 3b:

• Not having musculoskeletal pain but still "US-defined PsA" (i.e. with certain joint and/or entheseal inflammation as documented by US (see 'Definitions of patient populations' for definition))

Exclusion Criteria:

In general (all parts of study):

• Incapability of complying with the examination program of this protocol for physical, mental or practical reasons.

Part 2:

• Incapability of understanding spoken or written danish.

Part 3a:

  • Pregnancy, pregnancy wish or breast-feeding.
  • Hypersensitivity to the active substance (apremilast) or any of the excipients.
  • Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose
  • malabsorption
  • Severe renal failure (glomerular filtration rate (GFR) <30ml/min)
  • Current treatment with potent CYP3A4 enzyme inhibitors (rifampicin, phenobarbital, carbamazepin, phenytoin, perikon ("grønne lykkepiller" , Neurokan, Modigen, Calmigen, Velzina))
  • Current or planned (during the study period) treatment that might cause psychiatric symptoms
  • Known active tuberculosis (TB) or history of incompletely treated TB.
  • Clinical history of serious liver disease.
  • Hepatitis B antigen positivity or Hepatitis C antibodies positivity at screening (tests ≤3 months before inclusion is accepted).
  • Bacterial infections requiring antibiotics (oral or intravenously) or serious viral or fungal infections within the last four weeks before screening. Treatment of such infections should be completed 4 weeks prior to screening.
  • Clinical history of serious immunological disease (including HIV or other congenital or acquired immune disease) or other serious uncontrolled disease.
  • Current depression, previous depression, previous suicidal thoughts/tendencies or psychiatric symptoms
  • Conditions, including abnormal laboratory measurements, which might put the patient at an unnecessary risk by participation in the study or make data difficult to interpret.
  • Known inflammatory rheumatic disease other than PsA.
  • MRI substudy: Contraindications for MRI (see appendix 22.2.2)
  • Certain previous and concomitant treatment

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 3a (apremilast intervention)
Apremilast in standard dosis (gradual increase 0-30 mg x 2 daily over the first 6 days, hereafter 30 mg x 2 daily) for 6 months, followed by 6 months observation.
의약품: Apremilast Oral Tablet
As in description
간섭 없음: 3b (non-intervention)
Observation

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of participants with PsO reporting musculoskeletal pain within the past 12 months
기간: 1 day (At completion of questionnaire (performed once))
Part 1 - e-based questionnaire. Number of patients reporting joint- or entheseal pain within the past 12 months
1 day (At completion of questionnaire (performed once))
The difference in number of joints with US defined synovitis, in PsO patients with, compared to patients without musculoskeletal pain.
기간: Day 0
Part 2 - cross sectional study
Day 0
The difference in number of entheses with US defined enthesitis, in PsO patients with, compared to patients without musculoskeletal pain.
기간: Day 0
Part 2 - cross sectional study
Day 0
Change in OMERACT-EULAR Global US score of synovitis, from baseline to 6 months, in patients treated with apremilast (intervention group).
기간: 6 months
Part 3 - follow up study
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
The correlations between presence of musculoskeletal pain and patient reported outcomes of function, health related quality of life, and impact on patient's lives (including EQ5D, HAQ and PsAID)
기간: 1 day (At completion of e-based questionnaire (performed once))
Part 1
1 day (At completion of e-based questionnaire (performed once))
The prevalence of US defined synovitis at the individual 48 joints sites in patients with compared to patients without musculoskeletal pain.
기간: Day 0
Part 2
Day 0
The prevalence of US defined enthesitis at the individual 12 entheseal sites in patients with compared to patients without musculoskeletal pain.
기간: Day 0
Part 2
Day 0
The correlation between clinical and US scores of synovitis and enthesitis with patient reported outcomes of pain, function and impact on patient's lives (including pain, HAQ and PsAID).
기간: Day 0
Part 2
Day 0
Sensitivity and specificity of screening questionnaires, with fulfillment of CASPAR criteria as gold standard, and "US defined PsA" as alternative.
기간: Day 0
Part 2
Day 0
Change in "US total count of inflamed joints and entheses" from baseline to 3, 6 and 12 months, and from 6 to 12 months, in intervention and non-intervention groups.
기간: 3, 6, 12 months
Part 3
3, 6, 12 months
Change in patient global pain on a visual analogue scale (VAS, range 0-100), from baseline to 6 months and from 6 to 12 months in intervention group.
기간: 0-6 months, 6-12 months
Part 3
0-6 months, 6-12 months
Change in OMERACT-EULAR Global US score of synovitis from baseline to 3 and 6 months, and from 6 to 12 months, in intervention and non-intervention groups.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months
Change in US enthesitis activity score from baseline to 3, 6 and 12 months, and from 6 to 12 months, in intervention and non-intervention groups.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months
Change in PRO's (including PsAID, HAQ) from baseline to 3, 6, 9 and 12 months.
기간: 0-3-6-9-12 months
Part 3
0-3-6-9-12 months
The correlation between changes in clinical and US scores of synovitis and enthesitis and changes in patient reported outcomes, overall and in intervention and non-intervention groups.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months

기타 결과 측정

결과 측정
측정값 설명
기간
Change in DAS28-CRP (Disease Activity Score, 28 joints, CRP) from baseline to month 3 and 6, and from month 6 to month 12.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months
Change in PASDAS (Psoriatic Arthritis Disease Activity Score) from baseline to month 3 and 6, and from month 6 to month 12.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months
Change in DAPSA (Disease Activity Index for Psoriatic Arthritis) from baseline to month 3 and 6, and from month 6 to month 12.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months
Change in mCPDAI (modified Composite Psoriatic Disease Activity Index) from baseline to month 3 and 6, and from month 6 to month 12.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months
Evaluation of EULAR response criteria from baseline to month 3 and 6, and from month 6 to month 12.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months
Evaluation of ACR (American College of Rheumatology) response criteria from baseline to month 3 and 6, and from month 6 to month 12.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months
Evaluation of PsARC (Psoriatic Arthritis Response Criteria) from baseline to month 3 and 6, and from month 6 to month 12.
기간: 0-3-6-12 months
Part 3
0-3-6-12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Professor Mikkel Østergaard

협력자

Celgene Corporation
The Danish Rheumatism Association
The Danish Psoriasis Association

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)

2018년 12월 14일

기본 완료 (예상)

2021년 4월 1일

연구 완료 (예상)

2021년 10월 1일

연구 등록 날짜

최초 제출

2018년 12월 12일

QC 기준을 충족하는 최초 제출

2020년 8월 14일

처음 게시됨 (실제)

2020년 8월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 8월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 8월 14일

마지막으로 확인됨

2020년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DANPAPP
  • 2016-004354-15 (EudraCT 번호)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

Apremilast Oral Tablet에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Greece

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다