Thinking of joining a study?

Register your interest

NCT04833465 | RECRUITING | Juvenile Idiopathic Arthritis


Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
Sponsor:

Children's National Research Institute

Information provided by (Responsible Party):

Julia Finkel

Brief Summary:

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.

Condition or disease

Juvenile Idiopathic Arthritis

Systemic Lupus Erythematosus

Fibromyalgia

Intervention/treatment

No Intervention

Study Type : OBSERVATIONAL
Estimated Enrollment : 90 participants
Official Title : Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
Actual Study Start Date : 2021-07-16
Estimated Primary Completion Date : 2024-09-01
Estimated Study Completion Date : 2024-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 5 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • In order to be eligible for inclusion in the study, an individual must meet all of the following criteria
    • * Male or female ≥ 5 years of age at screening.
    • * Documentation of a JIA, SLE or FM diagnosis as evidenced by history
    Exclusion Criteria
    • Any individual who meets any of the following criteria will be excluded from participation in this study
      • • Documented history of eye disease precluding pupillometry

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Location Details

NCT04833465


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, District of Columbia

Children's National Health System

Washington, District of Columbia, United States, 20010

Loading...