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RecruitingPhase 4

Multi-Center PAMPA Study

Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will: 1."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether guselkumab can lower the risk of psoriatic arthritis, a type of joint inflammation linked to psoriasis. It is for adults with psoriasis who are at high risk for this joint disease. Researchers will check for changes on ultrasound scans at 24 weeks and signs of joint and tendon inflammation at 2 years.

This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care. The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will: 1. Diminish MSKPDUS findings at 24 weeks, and 2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older. Men and women may join.
  • Have psoriasis diagnosed by a skin doctor.
  • Have had psoriasis for more than 2 years, covering more than 3% of your skin.
  • Have signs on a muscle and joint ultrasound, with a study score above 3.36.
  • Be willing and able to give informed consent, meaning you understand and agree to join.

Who can't join

  • Have joint pain from inflammation, inflamed areas where tendons attach to bone, or swollen fingers or toes on an exam.
  • Currently take medicines that reduce immune activity, such as methotrexate or apremilast, or have ever used a biologic medicine.
  • Have medium-to-high levels of blood markers linked to rheumatoid arthritis, called RF or ACPA.
  • Have active cancer.
  • Have a history of painful osteoarthritis in several joints, or another joint condition that could make it hard to spot psoriatic arthritis.
  • Have a condition that makes guselkumab unsafe under its prescribing rules, including a significant active infection or untreated inactive tuberculosis.
  • Have a known allergy to guselkumab.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (3)

MA

  • Brigham and Women's Hospital · Boston, MA 02115Jeffrey Sparks, MD · Study contactJoseph Merola, MD, MMSc · Principal investigatorMore trials in Boston

NY