Novel Quantitative MRI for Axial Spondyloarthritis

NCT03778515 | Terminated

• 1 other identifier: 18-1327
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal aims to develop novel MR imaging and image processing techniques that will provide reliable and fully quantitative evaluation of inflammation, chronic structural changes and vascularity in patients with Ankylosing Spondylitis (AS). The quantitative evaluation will be more objective and reproducible, more sensitive to subtle changes, and less time consuming, as compared to the current semi-quantitative evaluation. It will allow radiologists and rheumatologists to evaluate the inflammation and structural changes more reliably to improve early diagnosis and treatment response evaluation. The developed quantification tools can be disseminated to other research and clinical sites for retrospective and prospective data analysis, and used as outcome measures for future multi-center trials. The evaluation of vascularity will enhance Investigators understanding of disease pathophysiology and serve as a novel marker to improve investigators capability of evaluating and predicting treatment response in AS. The successful implementation will greatly assist clinicians to optimize individualized therapeutic strategies and ultimately improve patient care for AS.

Conditions

Spondylitis, Ankylosing

Keywords

Axial; Spondyloarthritis; MRI; Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

• Change in Volume of MRI bone marrow edema (in cm^3) from Baseline at 48-weeks

  Fully quantitative evaluation of volume of bone marrow edema (in cm\^3) will be developed and applied in the study. Volume of BME will be calculated in both SIJ and Spine in high-resolution MR images to evaluate the active inflammation in the patients.

  Change from Baseline at 48-weeks

• Change in MRI grading SPARCC from Baseline at 48-weeks

  Inflammation and structural damages, including bone marrow edema, fatty deposition, erosions, syndesmophytes and ankylosis, in the spine and SIJs will be graded in MR images by certified radiologists using validated scoring systems developed by the Spondyloarthritis Research Consortium of Canada (SPARCC).

  Change from Baseline at 48-weeks

Secondary Outcomes (2)

• Change in C-reactive protein (CRP) (in mg/dL) from Baseline at 48-weeks

  Change from Baseline at 48-weeks

• Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP at Baseline, 4-weeks, 48-weeks

  Change from Baseline at 48-weeks

Study Arms (2)

Cases - Ankylosing Spondylitis Cohort

20 patients with ankylosing spondylitis (AS). Fifteen of these patients will be recruited from the Ankylosing Spondylitis clinic at the University of California, San Francisco. Five patients will be recruited from the Rheumatology clinic at the Cleveland Clinic. Observational with MRI.

Diagnostic Test: MRI

Controls - w/o Ankylosing Spondylitis

5 patients without AS and with no history of any arthritis or lower back pain in this study. These 5 patients will make up the control group of the study, which means that they will provide a benchmark of comparison for the results investigators obtain from the active AS group. 2 of these 5 patients will be recruited from Cleveland Clinic, and 3 will be recruited from UCSF. Observational with MRI

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Observational Study of novel MR imaging and image processing techniques that will provide reliable and fully quantitative evaluation of inflammation, chronic structural changes and vascularity in patients with Ankylosing Spondylitis (AS).

Cases - Ankylosing Spondylitis Cohort; Controls - w/o Ankylosing Spondylitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

15 patients will be recruited from the Ankylosing Spondylitis clinic at UCSF, and five patients will be recruited from Rheumatology clinic at the Cleveland Clinic. 10 patients with disease duration \<= 10 years, and ten patients with disease duration \> 10 years but without complete ankylosis. 5 healthy controls will be recruited for evaluating the measurement, with 2 from CCF and 3 from UCSF. The volunteers will be studied at baseline and 1-year follow up.

You may qualify if:

• Active AS meeting the modified New York criteria
• BASDAI ≥ 4
• Elevated C-Reactive Protein
• ≥ 18 years old
• Initiation of TNFi treatment with CZP

You may not qualify if:

• Previous treatment with more than one biologics
• Biologic treatment within six-months (no more than 20% of group (n=4) for patients with previous biologic treatment)
• Non-response to previous anti TNF treatment
• Fibromyalgia or other reasons for back pain
• Pregnant patients
• Patients on \> 10mg of Prednisone per day

Sponsors & Collaborators

• The Cleveland Clinic: lead
• University of California, San Francisco: collaborator
• UCB PHARMA Inc. (US): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthritis

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Xiaojuan Li, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xiaojuan Li, PhD, Professor, Department of Biomedical Engineering

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 19, 2018
• Study Start: January 15, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

US (1)