What side effects are associated with this type of intervention?

The most common treatments for Lyme arthritis, particularly NSAIDs, are known to reduce inflammation and pain by inhibiting pro-inflammatory cell mediators. However, they can also delay healing by inhibiting other cytokines involved in the recovery process. Common side effects of NSAIDs include gastrointestinal issues (such as ulcers and bleeding), renal impairment, and cardiovascular risks. These side effects necessitate cautious use, especially in patients with pre-existing conditions.

What prior FDA approvals exist?

The FDA has not specifically approved any drugs solely for the treatment of Lyme arthritis. However, NSAIDs, which inhibit pro-inflammatory cell mediators, are commonly used to manage symptoms. These medications help reduce inflammation and pain associated with Lyme arthritis. While NSAIDs are not a cure, they can provide symptomatic relief and are part of the broader management strategy for Lyme disease.

What other types of research exist?

Promising novel alternatives to NSAIDs for Lyme Arthritis patients include biologic therapies such as tumor necrosis factor (TNF) inhibitors (e.g., etanercept, infliximab) and Janus kinase (JAK) inhibitors (e.g., upadacitinib, tofacitinib). These treatments have shown efficacy in other inflammatory conditions and may offer benefits in managing Lyme Arthritis by targeting specific inflammatory pathways.

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Nonsteroidal Anti-inflammatory Drug

NSAIDs for Lyme Arthritis

Phase 3

Recruiting

Led By Desiree NW Neville, MD

Research Sponsored by Desiree Neville, MD

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Must not have

Hypersensitivity to acetaminophen or any component of the formulation; severe liver impairment or severe active liver disease

Underlying diagnosis of rheumatoid or recurrent arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if taking anti-inflammatory drugs regularly can help prevent long-term joint problems in people with Lyme disease. It focuses on patients who don't get better with antibiotics. The drugs work by reducing inflammation, which might stop the prolonged symptoms.

Who is the study for?

This trial is for individuals with Lyme arthritis who are testing positive for Lyme disease. It's not suitable for those with rheumatoid or recurrent arthritis, on daily NSAIDs or acetaminophen, have severe liver issues, a history of allergic reactions to NSAIDs, or underlying kidney or liver impairment.

What is being tested?

The study tests if scheduled use of the anti-inflammatory drug Naproxen, pain reliever Acetaminophen, or a combination can prevent prolonged symptoms in Lyme arthritis. Patients will be randomly assigned to one of these treatments and monitored for symptom duration and treatment side effects.

What are the potential side effects?

Possible side effects include digestive issues like stomach pain from Naproxen and potential liver damage from excessive Acetaminophen use. Allergic reactions may occur in sensitive individuals.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to acetaminophen or have severe liver problems.

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I have been diagnosed with rheumatoid or recurrent arthritis.

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I take NSAIDs or acetaminophen daily.

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I am currently taking NSAIDs regularly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in degree of joint movement determined by serial visual analog scale for joint movement via text surveys

Change in degree of overall function determined by serial visual analog scale for overall function via text surveys

Change in the degree of joint pain determined by serial visual analog scale for pain via text surveys

+2 more

Secondary study objectives

Change in medication compliance as determined by question in serial text survey

Development of medication side effects as determined by question in serial text survey

Fever as determined by question in serial text survey

+1 more

Other study objectives

Need for further care as determined by medical record review as number of visits in the system for Lyme arthritis symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: NSAID first, then AcetaminophenExperimental Treatment2 Interventions

Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve

Group II: NSAIDExperimental Treatment1 Intervention

Naproxen at weight based standard dose given bid daily until symptoms resolve

Group III: Standard CareActive Control1 Intervention

Symptom observation only

Group IV: AcetaminophenActive Control1 Intervention

Acetaminophen at weight based standard dose given qid until symptoms resolve

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naproxen

2019

Completed Phase 4

~31530

Acetaminophen

2017

Completed Phase 4

~2030

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lyme arthritis include antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Antibiotics target the underlying Borrelia burgdorferi infection, aiming to eradicate the bacteria and resolve symptoms. NSAIDs, on the other hand, work by inhibiting pro-inflammatory cell mediators, which helps reduce inflammation and alleviate pain. This is particularly important for Lyme arthritis patients because excessive inflammation can lead to prolonged symptoms and joint damage. By managing inflammation early, NSAIDs may help prevent the development of antibiotic-refractory Lyme arthritis, improving patient outcomes.

Successful reintroduction of tumour necrosis factor-alpha inhibition after treatment of disseminated Lyme borreliosis.[Reactive arthritis: from pathogenesis to novel strategies].[Effect of CTLA4-Ig on radiographic outcome of patients with rheumatoid arthritis].