Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Fibromyalgia Clinical Trial

Official title:

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833465
• Other study ID #: Pro00015629
• Status: Recruiting
• Start date: July 16, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Juvenile
• Fibromyalgia
• Juvenile Idiopathic Arthritis
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index Characterization	The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations.	1 Year
Secondary	Treatment Effect	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.	1 Year