Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Juvenile Arthritis Quantitative Imaging (JAQI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02684695
Recruitment Status : Recruiting
First Posted : February 18, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Bray, University College London Hospitals

Brief Summary:
This observational study aims to develop and validate quantitative magnetic resonance imaging biomarkers as measures of disease activity in juvenile idiopathic arthritis (JIA). This includes patients with enthesitis-related arthritis (ERA).

Condition or disease Intervention/treatment
Arthritis, Juvenile Idiopathic Enthesitis-Related Arthritis, Juvenile Other: MRI scan (adolescent spine protocol) Other: MRI scan (whole body protocol)

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Development and Validation of Quantitative Imaging Biomarkers as a Measure of Disease Activity in Juvenile Idiopathic Arthritis
Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2026


Group/Cohort Intervention/treatment
Group A
Patients with enthesitis-related arthritis
Other: MRI scan (adolescent spine protocol)
MRI scan of the lumbar spine and sacroiliac joints

Group B
Patients with other forms of juvenile idiopathic arthritis (extended oligoarticular JIA and polyarticular JIA)
Other: MRI scan (whole body protocol)
MRI scan of multiple joints ('whole body')




Primary Outcome Measures :
  1. Percentage agreement between novel biomarker measurements (apparent diffusion coefficient and fat fraction) and existing scores of inflammation (SPARCC STIR score) [ Time Frame: 5 years ]
    NB: Agreement is a single statistical parameter which is derived by comparison of two measurements - it is this parameter (rather than the measurements) which is the outcome measure.


Secondary Outcome Measures :
  1. Scoring systems for whole body imaging, and novel approaches to measuring bone marrow disease [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants with JIA will have a definitive clinical diagnosis of JIA according to established clinical criteria.9 Patients will be divided according to subtype - patients with ERA will be recruited into groups A (DWI and FF) and / or Group B (WB MRI) along with the polyarthritis and extended oligoarthritis groups. Once the WB MRI protocol is defined, for ERA patients recruited to both arms of the study the intention is to combine the DWI and WB MRI scan together to limit participation to 6 months scans only for this group.

Additionally, patients who are being investigated for possible JIA/ERA will be asked to participate in this study. Those patients who are subsequently diagnosed with JIA/ERA will be included in the study as described above. Those patients who are diagnosed with mechanical back pain will be treated as controls, and will not be imaged again after this point.

Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • For cases, patients will have clinical diagnosis of JIA: enthesitis-related arthropathy, extended oligoarthritis or polyarthritis (defined according to ILAR criteria)
  • For controls, patients will have a diagnosis of mechanical back pain (though to arise from muscles, bones, ligaments or discs), with normal inflammatory markers
  • Age 12-24

Exclusion Criteria:

  • Contra-indication to MRI scan (e.g. metal foreign object)
  • Unable to give consent
  • Unable to speak English
  • Unable to tolerate an MRI scan (e.g. due to claustrophobia, contrast allergy)
  • Renal or hepatic failure (eGFR < 30ml/min for renal failure, where applicable)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684695


Contacts
Layout table for location contacts
Contact: Timothy JP Bray, MBBChir 0203 447 9324 t.bray@ucl.ac.uk

Locations
Layout table for location information
United Kingdom
University College London Centre for Medical Imaging Recruiting
London, United Kingdom, NW12PG
Contact: Timothy JP Bray, MBBChir    0203 447 9324    t.bray@ucl.ac.uk   
Principal Investigator: Margaret A Hall-Craggs, MBBS         
Sponsors and Collaborators
University College London Hospitals

Layout table for additonal information
Responsible Party: Timothy Bray, Radiology SpR and PhD student, University College London Hospitals
ClinicalTrials.gov Identifier: NCT02684695    
Other Study ID Numbers: JAQI
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Timothy Bray, University College London Hospitals:
Magnetic resonance imaging
Imaging biomarker
Diffusion-weighted imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases