Multi-Center PAMPA Study

Launched by NYU LANGONE HEALTH · Aug 6, 2021

Keywords

ClinConnect Summary

The Multi-Center PAMPA Study is a clinical trial aimed at understanding how a medication called guselkumab can help patients with psoriasis who are at high risk of developing psoriatic arthritis (PsA). The trial will take place in several locations across North America and will compare the effects of guselkumab to a placebo (a substance with no active medication) in people who have had psoriasis for at least two years. Researchers hope to see if guselkumab can reduce signs of inflammation in the muscles and joints and prevent the development of PsA over two years.

To participate in this study, individuals must be 18 years or older and have been diagnosed with psoriasis for more than two years, with a certain level of skin involvement. Participants should not have any current joint pain or be using certain medications that may interfere with the study. If eligible, participants can expect to receive either the guselkumab treatment or a placebo, and they will be closely monitored over the course of the trial. This study is an important step toward finding better treatments for those at high risk of PsA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years old or older;
• • 2. Both male \& female;
• • 3. Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
• • 4. Willing and able to provide informed consent;
• • 5. Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration \>2 years and Psoriasis Body Surface Area (BSA) \>3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of \>3.36
• Exclusion Criteria:
• • 1. Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
• • 2. Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
• • 3. RA seropositivity (mid-high RF/ACPA titers);
• • 4. Current active malignancy;
• • 5. History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
• • 6. Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
• • 7. Known hypersensitivity to the study agent.