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Certolizumab for Pregnancy Complications Due to APS
Study Summary
This trial will evaluate if adding certolizumab to usual treatment will improve pregnancy outcomes in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 • 89 Patients • NCT03020992Trial Design
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Who is running the clinical trial?
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- My urine protein levels are high.I am a woman with a positive TB skin test or blood test.I am a woman taking more than 10 mg of prednisone daily for an autoimmune disorder.I have had tuberculosis or a positive TB skin test without treatment.I am a woman who is HIV, Hepatitis B, or Hepatitis C positive.I have tested positive for LAC twice over 12 weeks apart in the last 18 months.I have been diagnosed with antiphospholipid syndrome.I need more than 10 mg/day of prednisone for my lupus.I am between 18 and 40 years old and can consent to treatment.
- Group 1: Certolizumab Pegol
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 Certolizumab Pegol been certified by the FDA?
"Our internal evaluation assigns Certolizumab Pegol a safety rating of 2, as this phase 2 trial has only demonstrated preliminary evidence to support its security profile."
Have any further investigations been conducted regarding Certolizumab Pegol?
"Currently, a total of 17 studies are being conducted to assess the efficacy of Certolizumab Pegol. 4 trials have advanced to Phase 3. While Shanghai is hosting the majority of these investigations, there are 238 other sites across the globe running associated research projects."
Does this trial have any age restrictions, particularly for individuals beyond the age of seventy-five?
"In accordance with the outlined requirements, the minimum age for enrollment in this trial is 18 and any participants must not exceed 38 years of age."
Do I meet the criteria to become a participant in this trial?
"This research endeavour is looking to enrol 50 individuals, aged between 18 and 38 years old, who have experienced adverse birth outcomes."
To what maladies is Certolizumab Pegol typically administered?
"Certolizumab Pegol is frequently prescribed to individuals suffering from psoriatic arthritis but has been found helpful in the management of several other medical ailments, such as Crohn’s disease, rheumatoid arthritis and psoriasis."
Does this clinical investigation still have open slots for enrollment?
"Affirmative. According to the data on clinicaltrials.gov, this clinical trial has been open for recruitment since May 17th 2017 and was last updated April 28th 2022. The study aims to recruit 50 individuals across 3 different sites."
How many participants are taking part in this research endeavor?
"For this research project to be successful, 50 qualifying participants must enrol. The University of Utah in Salt Lake City and TRIO Advancing Reproductive Care in Toronto are two centres where individuals can sign up for the trial."
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