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Certolizumab for Pregnancy Complications Due to APS
Phase 2
Recruiting
Led By D. Ware Branch, MD
Research Sponsored by Ware Branch
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Antiphospholipid syndrome (APS)
Age 18-40 (+364 days) years of age and able to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks gestation through 6-weeks postpartum
Awards & highlights
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).
Who is the study for?
This trial is for pregnant women aged 18-40 with antiphospholipid syndrome (APS) and lupus anticoagulant (LAC), who are less than 8 weeks into their pregnancy. They must have a hematocrit >26% and no history of diabetes, multifetal gestation, certain infections like HIV or tuberculosis, high blood pressure at screening, or be on high doses of prednisone.Check my eligibility
What is being tested?
The IMPACT study tests whether adding certolizumab to standard treatment (heparin agent and low-dose aspirin) improves pregnancy outcomes in APS patients with positive LAC tests. All participants receive certolizumab; results will be compared to historical data from similar patients.See study design
What are the potential side effects?
Certolizumab may cause side effects such as infection risks due to immune system suppression, potential allergic reactions, possible heart failure in susceptible individuals, demyelinating disorders like Guillain-Barre syndrome, and could reactivate latent infections like tuberculosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with antiphospholipid syndrome.
Select...
I am between 18 and 40 years old and can consent to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks gestation through 6-weeks postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks gestation through 6-weeks postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fetal death and/or preterm delivery (<34 weeks) due to PE or PI in women with APS and LAC
Secondary outcome measures
Additional adverse outcomes or pertinent concerns, possibly related to study intervention
Side effects data
From 2020 Phase 4 trial • 89 Patients • NCT0302099217%
Nasopharyngitis
16%
Uveitis
13%
Upper respiratory tract infection
9%
Iridocyclitis
7%
Influenza
7%
Rhinitis
7%
Arthralgia
6%
Alanine aminotransferase increased
6%
Oropharyngeal pain
2%
Prostate cancer
2%
Vestibular disorder
1%
Haemangioma
1%
Pregnancy
1%
Anal polyp
1%
Incarcerated hernia
1%
Cholelithiasis
1%
Sarcoidosis
1%
Pneumonia haemophilus
1%
Pneumonia
1%
Tenosynovitis
1%
Breast cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Certolizumab Pegol (SS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Certolizumab PegolExperimental Treatment1 Intervention
All participants are administered certolizumab [400 mg (given as two subcutaneous injections of 200mg) initially and 2 and 4 weeks later, followed by 200 mg every other week thereafter.
1st dose of certolizumab will be administered by 8 weeks and 6 days gestation and discontinued at 27 weeks 6 days.
The regimen of heparin and low dose aspirin is a standard of care treatment for this patient population and is not considered part of the research intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Certolizumab Pegol
2013
Completed Phase 4
~5530
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Antiphospholipid Syndrome (APS) is commonly treated with anticoagulants like heparin and warfarin, which prevent blood clot formation by inhibiting clotting factors. Low-dose aspirin is also used to reduce platelet aggregation.
Certolizumab, an anti-TNF-alpha drug, is being studied for its potential to improve pregnancy outcomes in APS patients. TNF-alpha inhibitors like Certolizumab work by blocking the tumor necrosis factor-alpha, a cytokine involved in systemic inflammation.
This is particularly relevant for APS patients as inflammation plays a key role in the pathogenesis of the syndrome, contributing to clot formation and pregnancy complications. By reducing inflammation, anti-TNF-alpha drugs may help mitigate these risks.
[Immunosuppressive treatment after kidney transplant: the frontier of chronic antibody-mediated rejection].Intravenous immunoglobulin therapy in rheumatic diseases.
[Immunosuppressive treatment after kidney transplant: the frontier of chronic antibody-mediated rejection].Intravenous immunoglobulin therapy in rheumatic diseases.
Find a Location
Who is running the clinical trial?
Ware BranchLead Sponsor
1 Previous Clinical Trials
1,208 Total Patients Enrolled
Hospital for Special Surgery, New YorkOTHER
245 Previous Clinical Trials
59,455 Total Patients Enrolled
6 Trials studying Antiphospholipid Syndrome
820 Patients Enrolled for Antiphospholipid Syndrome
University of TorontoOTHER
693 Previous Clinical Trials
1,020,031 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Certolizumab Pegol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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