Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT04833465
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER
    No Intervention

Study Details

The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.

Key Dates

Start date
Jul 16, 2021
Status verified
Apr 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: JIA
    Patients ages 5-21 with a diagnosis of JIA.
  • Arm: SLE
    Patients ages 5-21 with a diagnosis of SLE.
  • Arm: FM
    Patients ages 5-21 with a diagnosis of FM.

Primary Outcome Measure

Index Characterization [ Time Frame: 1 Year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National Health SystemWashington D.C.District of Columbia20010
Julia C Finkel, MD
[email protected]
(202)476-4867
Julia C Finkel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Children's National Health System· Washington D.C., DC

Related Studies