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Guselkumab for Psoriatic Arthritis (STAR Trial)
STAR Trial Summary
This trial will study whether the drug guselkumab can reduce symptoms and inflammation in people with psoriatic arthritis that affects the spine.
STAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTAR 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 • NCT03573323STAR Trial Design
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Who is running the clinical trial?
Media Library
- I have active psoriasis with a plaque larger than 2 cm or nail changes.My back pain and stiffness are severe, scoring at least 4 out of 10.I have PsA with swelling and tenderness in at least 3 joints and high CRP levels despite previous treatments.I have been diagnosed with psoriatic arthritis for at least 6 months.My MRI shows Psoriatic Arthritis in my spine or sacroiliac joints.I have taken a JAK inhibitor medication before.I do not have conditions like RA, AS, lupus, or Lyme disease that could affect treatment results.I have received biological therapy before.You are allergic or very sensitive to guselkumab or any of its ingredients.I haven't taken any immune system suppressing drugs in the last 4 weeks.
- Group 1: Group 1: Guselkumab and Placebo
- Group 2: Group 2: Guselkumab
- Group 3: Group 3: Placebo followed by Guselkumab
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How many sites are hosting this investigatory endeavor?
"A variety of Kaiser Permanente hospitals, East Bay Rheumatology Medical Groups, and GCP Clinical Research facilities across 44 locations are currently participating in the recruitment process for this trial. Notable sites include Irvine, Florida; San Leandro, Nevada; and Tampa, Arizona."
Has Guselkumab secured regulatory approval from the FDA?
"Guselkumab has already been approved, so it was given the highest possible rating of 3 based on its Phase 4 status."
Is there precedent for this type of clinical inquiry?
"Janssen Research & Development, LLC initiated the first investigation into guselkumab in 2018. Following that initial trial involving 1,406 participants and subsequent Phase 2/3 approval, 19 active trials are ongoing spanning 287 cities across 57 different countries worldwide."
Is enrollment for this research study still open?
"According to clinicaltrials.gov, this research study is actively recruiting participants. The trial was first published on August 30th 2021 and its most recent update occurred December 1st 2022."
How many participants are currently involved in this clinical trial?
"In order to execute this investigation, 405 suitable participants are needed. Janssen Research & Development, LLC will be the primary sponsor and administer the trial from multiple sites including Kaiser Permanente in Irvine, Florida and East Bay Rheumatology Medical Group in San Leandro, Nevada."
What further research has been done concerning Guselkumab's effectiveness?
"Currently, 19 clinical trials related to Guselkumab are being conducted. Of those studies, seven have reached Phase 3 of the trial process. Milan and Kansas house most of these tests; however, there are over 2,700 additional sites where patients can access them."
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