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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

Summary

This trial is testing whether or not giving NSAIDs to patients with Lyme arthritis at the time of diagnosis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Need for further care as determined by medical record review as number of visits in the system for Lyme arthritis symptoms

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

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].

Find a Location

Who is running the clinical trial?

Desiree Neville, MDLead Sponsor
Desiree NW Neville, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Acetaminophen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04038346 — Phase 3
Lyme Arthritis Research Study Groups: Standard Care, NSAID, Acetaminophen, NSAID first, then Acetaminophen
Lyme Arthritis Clinical Trial 2023: Acetaminophen Highlights & Side Effects. Trial Name: NCT04038346 — Phase 3
Acetaminophen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04038346 — Phase 3
Lyme Arthritis Patient Testimony for trial: Trial Name: NCT04038346 — Phase 3
~145 spots leftby Dec 2028