Observational Study for Pediatric Rheumatoid Arthritis

Recruiting at 78 trial locations

Overseen By Mary Beth Son, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Age over 21

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information about children and teens with rheumatic diseases, which cause inflammation and pain in joints and muscles. The data collected will help answer important questions about the safety and effectiveness of treatments for these conditions. Individuals with a rheumatic disease that began before age 19 might be suitable candidates, especially if they are open to participating in future studies. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants an opportunity to contribute to the validation of a potentially effective treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study staff or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to gather comprehensive data on pediatric rheumatic diseases, which can lead to better understanding and management of these conditions. Unlike standard treatments that focus on managing symptoms, such as NSAIDs or DMARDs, this observational study seeks to identify patterns and outcomes across a wide patient population. By accumulating detailed information, researchers hope to uncover insights that could pave the way for more targeted and effective therapies in the future. This approach could revolutionize how we approach treatment for young patients with rheumatic diseases by tailoring care to their specific needs.

Who Is on the Research Team?

Timothy Beukelman, MD, MSCE

Principal Investigator

University of Alabama at Birmingham

Mara L Becker, MD, MSCE

Principal Investigator

Duke Clinical Research Insitute

Mary Beth Son, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).

Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.

Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Data collection on patients with pediatric-onset rheumatic diseases, including patient factors, therapies, and adverse events

10 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Indefinite as resources allow

What Are the Treatments Tested in This Trial?

Interventions

• Observational Study

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Childhood Arthritis and Rheumatology Research Alliance

Collaborator

Trials

5

Recruited

20,500+