Analysis of DNA Methylation in Spondyloarthritis

NCT03092583 | Completed

• 1 other identifier: P/2015/252
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to quantify global DNA methylation in patients with Ankylosing Spondylitis or Axial Spondyloarthritis as compared with control subjects.

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis; DNA Methylation

Outcome Measures

Primary Outcomes (1)

• Overall level of DNA methylation

  The level of methylation will be evaluated using the global quantification technique for DNA

  D0 (day of inclusion)

Secondary Outcomes (3)

• Expression of DNMT1 and MBD2

  D0 (day of inclusion)

• Methylation of the promoter region of TNF

  D0 (day of inclusion)

• Serum TNF-α

  D0 (day of inclusion)

Study Arms (2)

Patient group

EXPERIMENTAL

Subjects must meet the modified New York criteria for AS, or the ASAS criteria for Ax-SpA, and must be naïve of biologic therapy (anti-TNF-α agents) at the time of inclusion, or have received but subsequently discontinued anti-TNF-α therapy at least 3 months before inclusion. A blood sample will be drawn (35 mL) to these patients.

Other: Blood sample

Control group

OTHER

Subjects must be free from any inflammatory or auto-immune disease. A blood sample will be drawn (35 mL) to these controls subjects.

Other: Blood sample

Interventions

Blood sample OTHER

35 mL, 7 tubes

Control group; Patient group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects included in the Control group must be free from any inflammatory or auto-immune disease. Subjects being followed for spinal disc disease (herniated disc) or abarticular mechanical disease (tendonitis) will be eligible, as well as healthy subjects.
• Adult patients (≥18 years).
• Provide written informed consent indicating that the subject has understood the aims of the study, as well as the procedures involved, and that he/she accepts to participate and adhere to the demands and restrictions imposed by the study participation.
• All subjects must have social security coverage.
• Maximum age is 80 years.

You may not qualify if:

• Subjects being treated by systemic corticosteroids with a prednisone equivalent dose \>10 mg/day.
• Subjects with limited legal capacity.
• Subjects judged by the investigator to be unlikely to comply with study procedures
• Subjects with no social security coverage.
• Pregnant women.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

University Hospital

Besançon, 25000, France

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 28, 2017
• Study Start: February 15, 2017
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)