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Biological DMARD

Certolizumab for Rheumatoid Arthritis

N/A

Waitlist Available

Led By Katherine P Liao, MD, MPH

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Active RA as defined by treating rheumatologist

Age>35

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial is studying how well inflammation and lipoprotein atherogenicity (a measure of how likely a fat molecule is to cause problems in arteries) work together to predict cardiovascular risk in people with rheumatoid arthritis.

Who is the study for?

This trial is for adults over 35 with active Rheumatoid Arthritis (RA), who have not been treated with biologic DMARDs, and meet the ACR/EULAR RA criteria. It's not open to those with certain heart conditions, a history of serious cancers or recent cancer treatment, high-dose steroid therapy, severe asthma, pregnancy, active infections like HIV/TB/Hepatitis B/C, or those on specific cholesterol medications.Check my eligibility

What is being tested?

The study aims to understand how inflammation and lipid (fat) levels in the blood contribute to cardiovascular risk in people with RA. Participants will receive Certolizumab (a medication that targets inflammation) and undergo Stress myocardial perfusion PET scans to assess heart health.See study design

What are the potential side effects?

Certolizumab may cause side effects such as infection risks due to immune system suppression, injection site reactions, headaches, nausea and possibly allergic reactions. The PET scan is generally safe but can include discomfort at the injection site or allergic reaction to tracers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have rheumatoid arthritis that is currently being treated by a specialist.

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You have not previously used any biologic medications for your condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

coronary flow reserve (CFR) measured by cardiac PET

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tumor necrosis factor inhibitorExperimental Treatment2 Interventions

Subjects who are about to start on a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. They will have measurements including routine lipids, advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

certolizumab

2016

N/A

~80

Stress myocardial perfusion PET

2016

N/A

~80

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,619 Previous Clinical Trials

11,471,605 Total Patients Enrolled

23 Trials studying Rheumatoid Arthritis

588,911 Patients Enrolled for Rheumatoid Arthritis

Katherine P Liao, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Certolizumab (Biological DMARD) Clinical Trial Eligibility Overview. Trial Name: NCT02714881 — N/A

Rheumatoid Arthritis Research Study Groups: Tumor necrosis factor inhibitor

Rheumatoid Arthritis Clinical Trial 2023: Certolizumab Highlights & Side Effects. Trial Name: NCT02714881 — N/A

Certolizumab (Biological DMARD) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02714881 — N/A

Frequently Asked Questions

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

To what conditions is this therapeutic option typically applied?

"Traditionally, this therapeutic intervention is used to combat severe psoriatic arthritis. It has also shown some efficacy in treating a variety of other conditions including Crohn disease and regular arthritis."

Answered by AI

Could I be considered for this medical research program?

"The inclusion criteria for this trial requires that applicants have a diagnosis of rheumatoid arthritis and are between the ages of 35 and 90. At present, 74 patients must be enrolled."

Answered by AI

What prior research has been conducted in regards to this particular therapeutic approach?

"Currently, 17 medical trials exploring this type of treatment are underway with 4 of them in the third phase. Shanghai is a major centre for these clinical trials, but there are also 238 other sites running studies related to it."

Answered by AI

What is the maximum enrollment capacity of this experiment?

"This clinical trial has concluded recruitment and was last altered on July 18th 2022. If you would like to explore other options for rheumatoid arthritis, there are 1143 studies with open enrolment and 17 that specifically focus on this particular treatment."

Answered by AI

Are there still vacancies available for individuals to take part in this experimental trial?

"As of this moment, the trial is not accepting new participants. The posting for this clinical study first appeared on April 1st 2016 and was most recently updated on July 18th 2022. If you are looking to join another medical research program, there currently 1143 trials recruiting patients with Rheumatoid arthritis and 17 studies related to your treatment that need volunteers."

Answered by AI

Can individuals below the age of 45 partake in this trial?

"This clinical trial only enrolls patients aged 35 to 90 years old. Conversely, 106 studies are open for minors and 976 trials accept senior citizens as participants."

Answered by AI

Recent research and studies

Journal of the American Heart AssociationJournal

Relationship Between Risk of Atherosclerotic Cardiovascular Disease, Inflammation, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis

Weber, Brittany, Dana Weisenfeld, Thany Seyok, Sicong Huang, Elena Massarotti, Leanne Barrett, Courtney Bibbo, et al.. 2022. “Relationship Between Risk of Atherosclerotic Cardiovascular Disease, Inflammation, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis”. Journal of the American Heart Association. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/jaha.121.025467.

clinicaltrials.govStudy

Lipids, Inflammation, and CV Risk in RA

Katherine P Liao 2016. "Lipids, Inflammation, and CV Risk in RA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02714881.