능동적 성 건선 관절염을 가진 참가자에서 Ixekizumab의 개시 및 임상 실습에서 과체중 또는 비만에서 Ixekizumab의 시작 후 Tirzepatide의 효과를 조사하기위한 연구
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
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 장소
-
-
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
-
-
-
-
-
Guaynabo, 푸에르토 리코, 00968
- Reuviva Research Center
-
San Juan, 푸에르토 리코, 00918
- CMRC Headlands, LLC
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
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
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
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
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
수사관
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
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
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?
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
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .