Patient Centered Adaptive Treatment Strategies Using Bayesian Causal Inference

NCT02524340 | Completed

• 1 other identifier: PCATS for JIA
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

The best treatment plan for Juvenile Idiopathic Arthritis (JIA) is often complicated. Patients and clinicians often don't know what is the best treatment strategy for a given patient at a given time. The purpose of this study is to develop a method to analyze data in situations where the treatment and disease state change over time. The researchers will develop a web-based package that will use the methods developed in this study. The package will be easy to use and allow dissemination of the methods to the public.

Conditions

Juvenile Idiopathic Arthritis

Keywords

JIA; Arthritis; pcJIA; PCATS

Outcome Measures

Primary Outcomes (1)

• Clinical response measured by clinical Juvenile Arthritis Disease Activity Score (cJADAS)

  Clinical trials outcome measurement based on 3 measures that are collected during office visits. The three measures are: active joint count, physician global assessment, and parent global evaluation.

  1 years

Secondary Outcomes (1)

• Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) survey

  1 Years

Study Arms (1)

Juvenile Idiopathic Arthritis

Children diagnosed with Juvenile Idiopathic Arthritis

Eligibility Criteria

• Age: 1 Year - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children less or equal to 19 years of age that have been diagnosed with ployarticular course of juvenile idiopathic arthritis.

You may qualify if:

• Age ≤19 years at baseline
• Diagnosed with ployarticular course of juvenile idiopathic arthritis (pcJIA) follow the operational case definition of pcJIA presented in Table 2 of the journal article published by Ringold et al. (2014).
• Meet new patient definition, i.e. diagnosed with pcJIA no more than 6 month at the first clinical encounter captured in the database
• Taken DMARDs no more than 9 months after diagnosed with pcJIA

You may not qualify if:

• Systematic JIA patients according to the ILAR code
• Patients with comorbidities of inflammatory bowel disease (IBD), celiac disease, and trisomy 21.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bin Huang, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 14, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 23, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)