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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Administered SC
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
Chandler, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
Gilbert, Arizona, United States
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
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.
Time frame: 12 Months
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
Time frame: 12 Months
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Percentage of participants achieving TJC ≤1.
Time frame: Month 6 and Month 12
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
Percentage of participants achieving SJC ≤1.
Time frame: Month 6 and Month 12
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Percentage of participants achieving BSA ≤3%.
Time frame: Month 6 and Month 12
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
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.
Time frame: Month 6 and Month 12
Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
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."
Time frame: Month 6 and Month 12
Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."
Time frame: Month 6 and Month 12
Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
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.
Time frame: Month 6 and Month 12
Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
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).
Time frame: Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
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.
Time frame: Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
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.
Time frame: Month 6 and Month 12
Percentage of Participants Achieving a HAQ-DI score ≤0.5
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.
Time frame: Month 6
Percentage of Participants with ≥10% Weight Loss at Month 6
Percentage of participants with ≥10% weight loss at month 6.
Time frame: Month 6
Mean Percent Change of Weight from Baseline
Mean percent change of weight from baseline.
Time frame: Baseline, Month 6 and Baseline, Month 12
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
Sun City, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
Tucson, Arizona, United States
RECRUITINGAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson, Arizona, United States
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