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Tumour Necrosis Factor Inhibitor

Advanced Therapeutics for Rheumatoid Arthritis

Phase 4

Recruiting

Led By Janet E Pope, MD MPH

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

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

Must have

Failure of methotrexate and hydroxychloroquine and sulfasalazine

Active RA with 5 or more swollen joints

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will look at how well two advanced therapies, TNF and JAK, work to treat adults with Rheumatoid Arthritis over a two year period.

Who is the study for?

This trial is for adults with active Rheumatoid Arthritis who have at least 5 swollen joints, are seropositive, show joint erosion, and haven't responded to standard treatments like methotrexate. They must be able to consent and attend follow-up visits. It's not for those with serious infections, tuberculosis, multiple sclerosis, current or past cancer (including lymphoma), or previous advanced therapy use.Check my eligibility

What is being tested?

The study compares the retention rates of two RA treatments over two years: Etanercept (a TNF inhibitor) and Tofacitinib (a JAK inhibitor). It also assesses how well clinical trials can integrate into regular care using electronic medical records.See study design

What are the potential side effects?

Possible side effects include increased risk of infections due to immune system suppression by both drugs. Etanercept may cause injection site reactions while Tofacitinib might lead to headaches, diarrhea, and respiratory tract infections.

Eligibility Criteria

Inclusion Criteria

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

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Methotrexate, hydroxychloroquine, and sulfasalazine have not worked for me.

Select...

I have active rheumatoid arthritis with 5 or more swollen joints.

Select...

Leflunomide did not work for my condition.

Select...

I am 18 years old or older.

Select...

I have erosions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

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

Treatment Details

Study Objectives

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

Primary outcome measures

Retention Rates

Secondary outcome measures

Mean Change in Disease Activity

Trial Design

2Treatment groups

Active Control

Group I: etanerceptActive Control1 Intervention

etanercept 50 mg subcutaneously injected per week

Group II: tofacitinibActive Control1 Intervention

tofacitinib 5 mg orally daily

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,588 Total Patients Enrolled

3 Trials studying Rheumatoid Arthritis

534 Patients Enrolled for Rheumatoid Arthritis

Academic Medical Organization of Southwestern OntarioOTHER

13 Previous Clinical Trials

2,405 Total Patients Enrolled

Janet E Pope, MD MPHPrincipal InvestigatorWestern University, Canada

1 Previous Clinical Trials

63 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are joining this clinical trial?

"Affirmative. According to the information accessible on clinicaltrials.gov, this medical trial is actively searching for patients and was first posted back in March 1st 2020 and has been updated most recently on May 10th 2022. It seeks 144 participants from a single site."

Answered by AI

What other trials have been conducted to assess the efficacy of etanercept?

"Currently, 63 clinical trials regarding etanercept are in progress. 15 of those experiments have advanced to the third phase and 1312 different locations house these studies. Despite that vastness, Xi'an Shaanxi is where most research takes place for this particular treatment."

Answered by AI

In what circumstances is etanercept most frequently administered?

"Etanercept is medically approved to treat rheumatoid arthritis, psoriatic arthritis, and substandard response to traditional treatments."

Answered by AI

Are new participants sought for this investigation?

"Currently, this clinical trial is inviting participants to participate. It was initially announced on March 1st 2020 and its details were last revised May 10th 2022 according to the data hosted by clinicaltrials.gov."

Answered by AI

Is etanercept an acceptable form of medical intervention with minimal risk?

"By Power's assessment, etanercept is a safe and approved treatment with a safety score of 3. This conclusion was reached because this drug has successfully passed through Phase 4 clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Advanced Therapeutics in Rheumatoid Arthritis (RA)

2020. "Advanced Therapeutics in Rheumatoid Arthritis (RA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03976245.

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