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Certolizumab Pegol for Juvenile Idiopathic Arthritis (PASCAL Trial)
PASCAL Trial Summary
This trial looks at the effects of a drug called certolizumab pegol in children and adolescents with a type of arthritis called juvenile idiopathic arthritis.
PASCAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPASCAL 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 2012 Phase 4 trial • 736 Patients • NCT01255761PASCAL Trial Design
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Who is running the clinical trial?
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- I had a severe allergic reaction to a previous JIA treatment.I have been treated with more than 2 biologic agents.I have an inflammatory condition like lupus or IBD.I may have signs of an infection or have had serious infections recently.I have been treated for Juvenile Idiopathic Arthritis for at least 6 months.I have been diagnosed with systemic juvenile idiopathic arthritis.I have a non-inflammatory joint condition like fibromyalgia that affects how I might respond to the study medication.I have been on a stable dose of MTX for at least 4 months, or I stopped MTX due to side effects or it not working.I have active arthritis in 5 or more joints.I have tried at least one rheumatoid arthritis medication without success.I have been on a stable dose of corticosteroids for at least a week.I haven't taken any experimental treatments for my condition in the last 3 months or 5 half-lives, whichever is longer.I have been part of this study or treated with CZP before.I currently have, or often get, serious infections.I am between 2 and 17 years old.I weigh at least 22 pounds.I have had uveitis in the last 6 months or have it now.I have not responded to more than one TNFα blocker treatment.
- Group 1: Certolizumab Pegol
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What sort of benefits are researchers hoping to find from this clinical trial?
"The purpose of this study is to examine the levels of Anti-Certolizumab Pegol (anti-CZP) Antibody at Week 48. Additionally, responses such as the American College of Rheumatology Pediatric 30 % (PedACR30) Response at Week 16 will be monitored. This is defined as The assessment of the PedACR30 at Week 16 compared to Baseline based on a 30 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %.The 6 core set measures are:Number of joints with active"
What autoimmune disease does Certolizumab Pegol (CZP) help to manage?
"Cetolizumab Pegol, or CZP, is the most popular treatment for severe psoriatic arthritis. However, it's also useful in managing other inflammatory conditions like Crohn's disease and psoriatic arthritis."
What are some of the dangers associated with Certolizumab Pegol (CZP)?
"There is some evidence from previous trials to suggest that Certolizumab Pegol (CZP) is effective, and it has been through multiple rounds of testing to ensure safety. As such, our team rates its safety at a 3."
Who meets the medical eligibility requirements for this trial?
"This trial is looking for 193 patients with juvenile arthritis between the ages of 2 and 17. To be eligible, applicants must have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), been using methotrexate for a minimum of 3 months, and have active polyarticular-course disease."
Are there clinical sites in multiple states for this research?
"Patients are currently being accepted at this study's 23 locations, which include Durham, North carolina; New Hyde Park, New york; and Portland, Oregon."
Is this study open to new participants?
"As of right now, this clinical trial is not enrolling patients. The first posting was on March 8th, 2012 and the most recent update was September 9th, 2022. There are 385 other trials currently looking for participants that have arthritis and 17 for Certolizumab Pegol (CZP)."
Does this research involve any participants above the age of seventy?
"In order for children to participate in this study, they must be between the ages of 2 and 17."
How large is the sample size for this investigation?
"Presently, this clinical trial is not seeking participants. This particular study was initially posted on March 8th, 2012 and updated September 9th, 2022. There are 385 other trials actively recruiting patients with arthritis and 17 for Certolizumab Pegol (CZP)."
Are there any other notable studies that have used Certolizumab Pegol?
"There are a total of 17 clinical trials underway for Certolizumab Pegol (CZP), 4 of which are Phase 3 studies. The majority of these research projects are based in Shanghai, but there are 237 different locations running CZP trials."
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