144 Participants Needed
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's logo

Advanced Therapeutics for Rheumatoid Arthritis

Recruiting in London (>99 mi)
JE
Overseen ByJanet E Pope, MD MPH
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants must have failed treatments with methotrexate, hydroxychloroquine, sulfasalazine, and Leflunomide, which suggests that you may need to have tried these medications before joining the trial.

What safety data is available for Etanercept in treating rheumatoid arthritis?

Etanercept, also known as Enbrel, has been shown to be safe in treating rheumatoid arthritis, with rapid, dose-dependent improvements observed over 3 months in a phase II study. Common minor side effects include injection site reactions and upper respiratory tract infections, which typically do not require discontinuation of the medication. Some patients have reported an urticaria-like rash. Overall, Etanercept has demonstrated significant improvements in rheumatoid arthritis symptoms in placebo-controlled trials.12345

Is the drug Etanercept, Tofacitinib a promising treatment for rheumatoid arthritis?

Yes, Etanercept is a promising drug for treating rheumatoid arthritis. It has been shown to improve symptoms quickly and effectively when added to existing treatments. It works by targeting a specific protein involved in the inflammation process, helping to reduce the disease's activity.13678

What data supports the idea that Advanced Therapeutics for Rheumatoid Arthritis is an effective treatment?

The available research shows that Advanced Therapeutics for Rheumatoid Arthritis, specifically etanercept, is effective in treating the condition. One study found that etanercept led to rapid improvement in symptoms over three months. Another study showed that adding etanercept to methotrexate, a common treatment, provided additional benefits for patients who still had active disease. Additionally, research on children with juvenile rheumatoid arthritis indicated that etanercept was effective for those who did not respond well to methotrexate. These studies suggest that etanercept can be a beneficial option for managing rheumatoid arthritis.13679

Who Is on the Research Team?

JE

Janet E Pope, MD MPH

Principal Investigator

Western University, Canada

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Methotrexate, hydroxychloroquine, and sulfasalazine have not worked for me.
Leflunomide did not work for my condition.
I have active rheumatoid arthritis with 5 or more swollen joints.
See 5 more

Exclusion Criteria

I am currently diagnosed with cancer.
I am not allergic or unable to take etanercept or tofacitinib.
I have had lymphoma at some point.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either etanercept or tofacitinib for the treatment of Rheumatoid Arthritis

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Etanercept
  • Tofacitinib
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: etanerceptActive Control1 Intervention
Group II: tofacitinibActive Control1 Intervention

Etanercept is already approved in United States, European Union, Canada for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Enbrel for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Enbrel for:
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Enbrel for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
686
Recruited
427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
668
Recruited
424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials
17
Recruited
1,600+

Published Research Related to This Trial

In a randomized, double-blind, placebo-controlled trial involving 234 patients with active rheumatoid arthritis, etanercept demonstrated significant improvements in disease activity over 6 months, with 59% of patients achieving a 20% improvement compared to only 11% in the placebo group.
Etanercept was well tolerated and showed a dose-dependent effect, with no dose-limiting toxic effects, confirming its safety and efficacy as a treatment for rheumatoid arthritis.
Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial.Moreland, LW., Schiff, MH., Baumgartner, SW., et al.[2022]
In a 24-week study involving 89 patients with rheumatoid arthritis who were not responding adequately to methotrexate alone, the addition of etanercept significantly improved clinical outcomes, with 71% of patients achieving a 20% improvement in disease activity compared to only 27% in the placebo group.
The combination therapy was safe and well tolerated, with only mild injection-site reactions reported, indicating that etanercept can be a beneficial addition to methotrexate for patients with persistent disease activity.
A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate.Weinblatt, ME., Kremer, JM., Bankhurst, AD., et al.[2022]
In a three-month trial involving 180 patients with refractory rheumatoid arthritis, the novel TNF antagonist TNFR:Fc significantly reduced disease activity, with 75% of patients receiving the highest dose (16 mg/mยฒ) showing a 20% or greater improvement in symptoms compared to only 14% in the placebo group.
TNFR:Fc was found to be safe and well-tolerated, with only mild injection-site reactions and upper respiratory symptoms reported, and no serious side effects or antibodies against the treatment detected.
Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein.Moreland, LW., Baumgartner, SW., Schiff, MH., et al.[2022]

Citations

Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. [2022]
A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. [2022]
Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. [2022]
Construction and purification of the murine p75-murine IgG1 fusion protein. [2016]
Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. [2022]
Etanercept and urticaria in patients with juvenile idiopathic arthritis. [2017]
Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study. [2022]
Soluble tumor necrosis factor receptor (p75) fusion protein (ENBREL) as a therapy for rheumatoid arthritis. [2019]
Tumor necrosis factor inhibitors: new options for treating rheumatoid arthritis. [2015]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity