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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 below
Select...
I have been diagnosed with antiphospholipid syndrome.
Select...
I am between 18 and 40 years old and can consent to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks gestation through 6-weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks gestation through 6-weeks postpartum for reporting.

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 • NCT03020992
17%
Nasopharyngitis
16%
Uveitis
13%
Upper respiratory tract infection
9%
Iridocyclitis
7%
Influenza
7%
Rhinitis
7%
Arthralgia
6%
Alanine aminotransferase increased
6%
Oropharyngeal pain
2%
Vestibular disorder
2%
Prostate cancer
1%
Anal polyp
1%
Incarcerated hernia
1%
Cholelithiasis
1%
Sarcoidosis
1%
Pneumonia haemophilus
1%
Pneumonia
1%
Tenosynovitis
1%
Breast cancer
1%
Haemangioma
1%
Pregnancy
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

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
242 Previous Clinical Trials
61,847 Total Patients Enrolled
6 Trials studying Antiphospholipid Syndrome
820 Patients Enrolled for Antiphospholipid Syndrome
University of TorontoOTHER
687 Previous Clinical Trials
1,018,315 Total Patients Enrolled

Media Library

Certolizumab Pegol Clinical Trial Eligibility Overview. Trial Name: NCT03152058 — Phase 2
Antiphospholipid Syndrome Research Study Groups: Certolizumab Pegol
Antiphospholipid Syndrome Clinical Trial 2023: Certolizumab Pegol Highlights & Side Effects. Trial Name: NCT03152058 — Phase 2
Certolizumab Pegol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03152058 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~5 spots leftby Dec 2024