The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe 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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