Trial · Interventional
Active, not recruitingPhase 4Registry dataA Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)
Overview
- Status
- Active, not recruiting
- Phase
- Phase 4
- Enrollment
- 200 participants (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
2 countries
United States, Puerto Rico
- Start
- 6 Mar 2025
- Primary completion
- Aug 2027 (estimated)
- Completion
- Aug 2027 (estimated)
- First posted
- 7 Mar 2025
- Last update posted
- 21 Sept 2026
- Conditions
- Psoriatic Arthritis · Overweight or Obesity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)
NCT068640266 Mar 2025 to est. Aug 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- TirzepatideDrug
Arms1
Experimental
Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
Primary outcomes2
Outcomes the sponsor listed as primary.
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Time frame · 12 Months
Registry description
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.
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
Time frame · 12 Months
Registry description
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
Secondary outcomes(13)
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Time frame · Month 6 and Month 12
Registry description
Percentage of participants achieving TJC ≤1.
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
Time frame · Month 6 and Month 12
Registry description
Percentage of participants achieving SJC ≤1.
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Time frame · Month 6 and Month 12
Registry description
Percentage of participants achieving BSA ≤3%.
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
Time frame · Month 6 and Month 12
Registry description
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.
Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
Time frame · Month 6 and Month 12
Registry description
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."
Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
Time frame · Month 6 and Month 12
Registry description
The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."
Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
Time frame · Month 6 and Month 12
Registry description
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.
Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
Time frame · Month 6 and Month 12
Registry description
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).
Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
Time frame · Month 6 and Month 12
Registry description
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.
Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
Time frame · Month 6 and Month 12
Registry description
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.
Percentage of Participants Achieving a HAQ-DI score ≤0.5
Time frame · Month 6
Registry description
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.
Percentage of Participants with ≥10% Weight Loss at Month 6
Time frame · Month 6
Registry description
Percentage of participants with ≥10% weight loss at month 6.
Mean Percent Change of Weight from Baseline
Time frame · Baseline, Month 6 and Baseline, Month 12
Registry description
Mean percent change of weight from baseline.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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