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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
Must not have
Current cancer
No contraindication to etanercept or tofacitinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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.
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.
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.
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I have active rheumatoid arthritis with 5 or more swollen joints.
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Leflunomide did not work for my condition.
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I am 18 years old or older.
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I have erosions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently diagnosed with cancer.
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I am not allergic or unable to take etanercept or tofacitinib.
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I am under 18 years old.
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I do not have active tuberculosis.
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I am currently fighting a serious infection.
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I have been diagnosed with multiple sclerosis.
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I am unable to give my consent.
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I have used advanced therapy like biologics or JAK inhibitors before.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Retention Rates
Secondary study objectives
Mean Change in Disease Activity

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
421,318 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
534 Patients Enrolled for Rheumatoid Arthritis
Academic Medical Organization of Southwestern OntarioOTHER
15 Previous Clinical Trials
1,289 Total Patients Enrolled
Janet E Pope, MD MPHPrincipal InvestigatorWestern University, Canada
1 Previous Clinical Trials
63 Total Patients Enrolled
~7 spots leftby Mar 2025
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