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)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tirzepatide

    Drug

    Administered SC

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: TirzepatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Percentage of Participants Achieving Tender Joint Count (TJC) ≤1

Percentage of participants achieving TJC ≤1.

Time frame
Month 6 and Month 12
2

Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1

Percentage of participants achieving SJC ≤1.

Time frame
Month 6 and Month 12
3

Percentage of Participants Achieving Body Surface Area (BSA) ≤3%

Percentage of participants achieving BSA ≤3%.

Time frame
Month 6 and Month 12
4

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

Other outcomes

Sponsors and contacts

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