DEUCRAVACITINIB for Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening"}
• {"criterion_text":"- Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening"}
• {"criterion_text":"- Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening"}
• {"criterion_text":"- Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1"}
• {"criterion_text":"- Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening"}
• {"criterion_text":"- ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading"}

Exclusion criteria

• {"criterion_text":"- Nonplaque psoriasis at screening or day 1"}
• {"criterion_text":"- Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease,multiple sclerosis, or vasculitis"}
• {"criterion_text":"- History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)"}
• {"criterion_text":"- Active fibromyalgia"}
• {"criterion_text":"- Received an approved or investigational biologic therapy for the treatment of PsA or PsO"}
• {"criterion_text":"- Participant has received a JAK inhibitor for the treatment of PsA and/or PsO."}

Primary endpoints

• {"endpoint_text":"- Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response at Week 16","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in DAS28-CRP score at Week 16","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from baseline in HAQ-DI score at Week 16","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants meeting PASI 75 response at Week 16, in participants with at least 3% BSA involvement AND at least sPGA 2 at baseline","definition_or_measurement_approach":"PASI 75 response assessed at Week 16 among participants who had ≥3% BSA involvement and sPGA ≥2 at baseline."}
• {"endpoint_text":"- Change from baseline in the SF-36 PCS score at Week 16","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at baseline by LEI at Week 16","definition_or_measurement_approach":"Enthesitis resolution defined as LEI score of 0 at Week 16 among participants with enthesitis at baseline."}
• {"endpoint_text":"- Proportion of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: a) Tender joint count ≤ 1 b) Swollen joint count ≤ 1 c) PASI ≤ 1 or BSA ≤ 3% d) Patient assessment of PsA pain ≤ 15 e) Patient Global Assessment of PsA disease activity ≤ 20 f) HAQ-DI ≤ 0.5 g) Tender enthesial points ≤ 1","definition_or_measurement_approach":"MDA is achieved when 5 of the 7 listed component criteria are met at Week 16 (components a–g as specified)."}
• {"endpoint_text":"- Change from baseline in FACIT-Fatigue score at Week 16","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline","definition_or_measurement_approach":"Dactylitis resolution defined as tender dactylitis count = 0 at Week 16 among participants with baseline tender dactylitis count ≥1."}
• {"endpoint_text":"- Change from baseline in PsA-modified SvdH score at Week 16","definition_or_measurement_approach":""}

Methods

• Study invitation website / homepage recruitment materials (country-specific K2 recruitment material documents; e.g., 'K2_Recruitment material_Psoriatic Arthritis_Homepage')
• Printed recruitment materials and patient brochures (country-specific K2 recruitment material_Patient Brochure documents)
• Posters and banners for patients (country-specific K2 recruitment material_Patient Poster and banner documents; examples include PL, ES, FI, BG versions)
• Social media posts (Facebook) (documents titled 'K2_ Recruitment material_postare-Facebook-regular' and carousel variants)
• Study invitation and site-specific recruitment arrangements documents (K1_ Recruitment arrangements documents per country)

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Iqvia Inc.

Responsibilities

Operational support including SUSAR reporting and multiple study operational roles (various sponsorDuties codes)

Name

Medidata Solutions Inc.

Responsibilities

Data management platform

Name

Bioclinica Inc.

Responsibilities

Medical image analysis/ review - X-ray, MRI, ultrasound, etc.

Name

Myriad RBM Inc.

Responsibilities

Specialty Biomarker Laboratory; Exploratory Serum Biomarkers analysis

Third parties

• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Storage of serum, plasma, and whole-blood samples","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratories Inc.","duties_or_roles":"Data entry of Local Laboratory Values","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Q2 Solutions","duties_or_roles":"Sample mgmt, Kit building, Storage and distribution to other vendor for analysis","organisation_type":"Health care"}
• {"country":"India","full_name":"Accenture Solutions Private Limited (Chennai site)","duties_or_roles":"Pharmacovigilance: Medical review & Cases Data Entry.","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited (Bengaluru site)","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"Specialty Biomarker Laboratory; Exploratory Serum Biomarkers analysis","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data management platform","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Multiple operational roles including SUSAR reporting and other clinical operations functions (codes present in sponsor duties)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Health care"}