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Guselkumab for Psoriasis (PAMPA Trial)
PAMPA Trial Summary
This trial will test whether the intervention of Guselkumab will reduce the risk for developing psoriatic arthritis in high-risk psoriasis patients.
PAMPA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPAMPA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 1027 Patients • NCT03573323PAMPA Trial Design
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Who is running the clinical trial?
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- I have joint pain, swelling at tendon attachment sites, or sausage-like swelling in fingers or toes.I have been diagnosed with psoriasis by a dermatologist for at least 2 years.I do not have an active infection or untreated latent TB.I am 18 years old or older.I have had psoriasis for over 2 years, it covers more than 3% of my body, and my ultrasound score is over 3.36.I have moderate to high levels of rheumatoid arthritis markers.I have a joint condition like arthritis that could affect PsA assessments.I have had psoriasis for over 2 years, it covers more than 3% of my body, and my ultrasound score is over 3.36.I am either male or female.I am 18 years old or older.I have an active cancer.I am currently taking medication that suppresses my immune system.My gender does not affect my eligibility.
- Group 1: Placebo + Topicals (PBO)
- Group 2: Standard-of-Care Therapy (SOC)
- Group 3: Guselkumab + Topicals (GUS)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Guselkumab attained regulatory authorization from the FDA?
"As this treatment holds an approved Phase 4 status, our analysis gave guselkumab a score of 3 in terms of safety."
How many facilities are actively managing this trial?
"This clinical trial has enlisted 5 institutions for participation, such as NYU Langone Health in New york, Memorial University in Saint John's, and the URMC of Rochester. Five additional locations are also participating."
Is this research the first of its kind?
"Since its inception in 2018, Guselkumab has been subject to intense research. Janssen Research & Development, LLC sponsored the first study regarding this drug which had 1406 participants. Following a successful Phase 2 and 3 trial period, 19 ongoing studies involving 287 cities and 57 nations are examining the efficacy of Guselkumab today."
What is the objective of this experiment?
"This trial will measure its efficacy by evaluating the Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score over a two year period. Secondary outcomes being tracked include Percentage of Patients Transitioning to Psoriatic arthritis (PsA) by Modified CASPAR Criteria at Year 1 and Madrid Sonographic Enthesis Index (MASEI), as well as EuroQol-5D (EQ-5D). To meet criteria for PsA diagnosis, participants must have inflammatory articular disease plus three points from psoriasis history or family history, typical psoriatic nail"
Does this experiment currently have any space for new participants?
"Affirmative. Clinicaltrials.gov details that this medical trial is currently looking to recruit 350 participants from 5 different sites, and was first advertised on February 16th 2022 with an update posted September 29th 2022."
What further investigations have been undertaken regarding Guselkumab?
"Guselkumab was initially tested at the Harmony Medical Research Institute, Inc. in 2018 and has since seen 18344 completed trials. Currently there are 19 live clinical studies taking place primarily in New york City."
How many test subjects are being monitored for this scientific inquiry?
"350 individuals who fit the pre-defined requirements are needed to partake in this medical experiment. Patients can take part from NYU Langone Health, New york and Memorial University located in Saint John's, Newfoundland and Labrador."
Who else is applying?
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