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

능동적 성 건선 관절염을 가진 참가자에서 Ixekizumab의 개시 및 임상 실습에서 과체중 또는 비만에서 Ixekizumab의 시작 후 Tirzepatide의 효과를 조사하기위한 연구

2026년 9월 18일 업데이트: Eli Lilly and Company

4 상, 전향 적, 개방형, 단일 암 연구는 능동적 성 건선 관절염을 가진 성인 참가자 및 임상 실습에서 과체중 또는 비만에서 Ixekizumab의 시작 후 티르 제이 타드의 효과를 평가하기위한 4 단계.

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with active PsA and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

200

단계

  • 4단계

연락처 및 위치

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

연구 장소

  • 미국
    • Arizona
      • Avondale, Arizona, 미국, 85392
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
      • Chandler, Arizona, 미국, 85225
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
      • Flagstaff, Arizona, 미국, 86001
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
      • Gilbert, Arizona, 미국, 85297
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
      • Glendale, Arizona, 미국, 85306
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
      • Mesa, Arizona, 미국, 85210
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
      • Phoenix, Arizona, 미국, 85032
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
      • Sun City, Arizona, 미국, 85351
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
      • Tucson, Arizona, 미국, 85748
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
      • Tucson, Arizona, 미국, 85704
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
    • California
      • Apple Valley, California, 미국, 92307
        • Medvin Clinical Research - Apple Valley
      • Covina, California, 미국, 91722
        • Medvin Clinical Research - Covina
      • Huntington Beach, California, 미국, 92648
        • Newport Huntington Medical Group
      • La Mesa, California, 미국, 91942
        • Purushotham & Akther Kotha MD, Inc
      • Riverside, California, 미국, 92508
        • Medvin Clinical Research - Riverside
      • San Diego, California, 미국, 92128
        • Rheumatology Center of San Diego
      • Santa Monica, California, 미국, 90404
        • Providence Saint John's Medical Foundation
      • Temecula, California, 미국, 92592
        • Medvin Clinical Research - Temecula
      • Tujunga, California, 미국, 91042
        • Medvin Clinical Research - Tujunga
      • Whittier, California, 미국, 90602
        • Medvin Clinical Research - Whittier
    • Florida
      • Kissimmee, Florida, 미국, 34741
        • Vida Clinical Research
      • Margate, Florida, 미국, 33063
        • Life Clinical Trials
      • Miami Beach, Florida, 미국, 33140
        • CZ Rheumatology
      • Palm Beach Gardens, Florida, 미국, 33410
        • Vitalia Medical Research
      • Tampa, Florida, 미국, 33614
        • International Center for Research
    • Georgia
      • Marietta, Georgia, 미국, 30060
        • Atlanta Research Center for Rheumatology
      • Waycross, Georgia, 미국, 31501
        • Satilla Rheumatology & Internal Medicine
    • Illinois
      • Chicago, Illinois, 미국, 60640
        • Great Lakes Clinical Trials - Ravenswood
      • Schaumburg, Illinois, 미국, 60195
        • Greater Chicago Specialty Physicians
      • Skokie, Illinois, 미국, 60076
        • Arnold Arthritis & Rheumatology
      • Willowbrook, Illinois, 미국, 60527
        • Willow Rheumatology and Wellness PLLC
    • Indiana
      • New Albany, Indiana, 미국, 47150
        • Lake Cumberland Rheumatology
    • Louisiana
      • Lake Charles, Louisiana, 미국, 70605
        • Accurate Clinical Research, Inc
    • Maryland
      • Cumberland, Maryland, 미국, 21502
        • Klein & Associates, M.D., P.A.
      • Hagerstown, Maryland, 미국, 21740
        • Klein & Associates, M.D., P.A.
    • Michigan
      • Saint Clair Shores, Michigan, 미국, 48081
        • Clinical Research Institute of Michigan, LLC
    • Montana
      • Kalispell, Montana, 미국, 59901
        • Logan Health Rheumatology
    • New York
      • Rochester, New York, 미국, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Salisbury, North Carolina, 미국, 28144
        • Onsite Clinical Solutions, LLC - Brenner Ave
    • Ohio
      • Middleburg Heights, Ohio, 미국, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74137
        • Essential Medical Research
    • Tennessee
      • Jackson, Tennessee, 미국, 38305
        • West Tennessee Research Institute
      • Murfreesboro, Tennessee, 미국, 37128
        • AARA Clinical Research - Murfreesboro Medical Clinic
    • Texas
      • Colleyville, Texas, 미국, 76034
        • Precision Comprehensive Clinical Research Solutions - Colleyville
      • Fort Worth, Texas, 미국, 76109
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
      • Houston, Texas, 미국, 77089
        • Research Physicians Network, LLC
      • Houston, Texas, 미국, 77089
        • Accurate Clinical Research, Inc
      • Irving, Texas, 미국, 75039
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
      • Katy, Texas, 미국, 77494
        • Biopharma Informatic, LLC
      • The Woodlands, Texas, 미국, 77382
        • Advanced Rheumatology of Houston - Woodlands
      • Tomball, Texas, 미국, 77375
        • DM Clinical Research - TRA
    • Washington
      • Seattle, Washington, 미국, 98104
        • Seattle Rheumatology Associates PLLC
      • Spokane Valley, Washington, 미국, 99216
        • Arthritis Northwest, PLLC
  • 푸에르토 리코
      • Guaynabo, 푸에르토 리코, 00968
        • Reuviva Research Center
      • San Juan, 푸에르토 리코, 00918
        • CMRC Headlands, LLC

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:

  • Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA.
  • Body Mass Index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m2 to <30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).
  • Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide.
  • Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening).

Exclusion Criteria:

  • Have currently received ixekizumab for more than 4 months or less than 2 months.
  • Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide).
  • Are currently enrolled in any other clinical study.
  • Have a known hypersensitivity to any component of tirzepatide.
  • Have a personal or family history of medullary thyroid cancer.
  • Have multiple endocrine neoplasia type 2.
  • Have type 1 diabetes mellitus.
  • Have a history of chronic or acute pancreatitis at any time before screening.
  • Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.
  • Have a history of ketoacidosis or hyperosmolar state/coma.
  • Have a history of severe hypoglycemia unawareness within the 6 months before screening.
  • Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.

공부 계획

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

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: Tirzepatide

Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
의약품: Tirzepatide

Administered SC

다른 이름들:
  • LY3298176

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
기간: 12 Months

The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
12 Months
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
기간: 12 Months

Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
12 Months

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
기간: Month 6 and Month 12

Percentage of participants achieving TJC ≤1.
Month 6 and Month 12
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
기간: Month 6 and Month 12

Percentage of participants achieving SJC ≤1.
Month 6 and Month 12
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
기간: Month 6 and Month 12

Percentage of participants achieving BSA ≤3%.
Month 6 and Month 12
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
기간: Month 6 and Month 12

The PaGADA NRS is an 11-point scale from 0 to 10 that is anchored by 2 verbal descriptors, "very well" and "very poor." Higher scores represent a higher level of disease activity.
Month 6 and Month 12
Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
기간: Month 6 and Month 12

The Patient's Assessment of Arthritis Pain is a single-item, patient-reported outcome instrument, used to access the current severity of participants' joint pain in relation to their PsA on a horizontal VAS of 0 to 100 mm. The Patient's Assessment of Arthritis Pain is anchored by 2 verbal descriptors, "no pain" and "as severe as can imagine."
Month 6 and Month 12
Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
기간: Month 6 and Month 12

The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."
Month 6 and Month 12
Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
기간: Month 6 and Month 12

The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Month 6 and Month 12
Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
기간: Month 6 and Month 12

FACIT-F is a patient-reported, 13-item questionnaire that specifically assess the self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses 0 ("not at all") to 4 ("very much") Likert scale to assess fatigue and its impact in the past 7 days. Total score ranges from 0 to 52, based on a rating of 5-point Likert scale. Scores for negatively worded items are reversed, such that higher scores are better (that is, less fatigue).
Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
기간: Month 6 and Month 12

The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
기간: Month 6 and Month 12

The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Month 6 and Month 12
Percentage of Participants Achieving a HAQ-DI score ≤0.5
기간: Month 6

The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Month 6
Percentage of Participants with ≥10% Weight Loss at Month 6
기간: Month 6

Percentage of participants with ≥10% weight loss at month 6.
Month 6
Mean Percent Change of Weight from Baseline
기간: Baseline, Month 6 and Baseline, Month 12

Mean percent change of weight from baseline.
Baseline, Month 6 and Baseline, Month 12

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eli Lilly and Company

수사관

  • 연구 책임자: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

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)

2025년 3월 6일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2027년 8월 1일

연구 등록 날짜

최초 제출

2025년 3월 3일

QC 기준을 충족하는 최초 제출

2025년 3월 4일

처음 게시됨 (실제)

2025년 3월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 18일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 27350
  • I1F-MC-RHDE (기타 식별자: Eli Lilly and Company)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD 공유 기간

Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD 공유 액세스 기준

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .

구독하다