A Study of Novel Immune Modulating Biomarkers in Patients With Spondyloarthritis With Axial Involvement

NCT01969188 | Completed

• 1 other identifier: 2014-227
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Spondyloarthritis refers to a set of inflammatory disorders that mainly afflict the spine, joints and ligaments. A subtype of spondyloarthritis is Ankylosing Spondylitis - now known as axial spondyloarthropathy - which is characterized by inflammation of the joints in the spinal column, and the part of the back where the spine meets the pelvis. Another subtype of spondyloarthritis is Psoriatic Arthritis where patients often develop raised patches of reddened skin. The disease can advance to one of more joints in the body resulting in pain, swelling and stiffness. These forms of inflammatory arthritis can become chronic and over time can lead to pain, disability and deformity. There is now evidence that patients with inflammatory arthritis that are diagnosed and treated earlier in the course of their symptoms may have better results. Yet although we know that early treatment is important, the investigators still don't know if there are factors that can predict how an individual patient's disease will progress over time in terms of losing mobility. The investigators also do not know the relationship between loosing mobility and the formation of bone around the spine and joints. The investigators are doing this study because the investigators want to learn more about patients with these forms of arthritis - Ankylosing Spondylitis and Psoriatic Arthritis. The investigators want to learn more about the factors that can predict how their disease might progress over time and what their response to treatment might be. The investigators would also like to determine the proportion of patients with these types of symptoms and describe the best treatment strategies for them.

Conditions

Spondyloarthritis

Keywords

spondyloarthritis; ankylosing spondylitis; psoriatic arthritis

Outcome Measures

Primary Outcomes (1)

• Correlation between the change in IL-23R(Interleukin-23 receptor) levels and disease activity at one year and two years.

  The primary outcome will be the correlation between IL-23R levels measured by flow cytometry with disease activity in patients with SpA as measured by the ASDAS, at one year and at two years.

  12 months and 24 months.

Secondary Outcomes (1)

• Difference in peripheral blood IL-23R levels in "responders", and correlation of other immune modulators and inflammatory cytokines

  12 months and 24 months

Study Arms (1)

SpA in RA

Patients with SpA with psoriatic arthritis (PsA), ankylosing spondylitis (AS), no biologic therapy for 3 months, over 18 yrs old.

Eligibility Criteria

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

Study Population

Patients with a confirmed diagnosis of spondloarthritis with axial involvement and no biologic treatment in most recent three months (see inclusion criteria).

You may qualify if:

• Patients with SpA should have a BASDAI of \> 3.5 with radiographic evidence and a BASDAI of \> 4 without radiographic evidence
• No biologic therapy for ≥ 4-6 weeks. Patients may have had a TNFi \> 6 weeks prior to study entry, but patients currently receiving, for example, adalimumab, etanercept, infliximab, golimumab, certolizumab pegol or who have taken any TNFis within the previous 4-6 weeks are ineligible. They must have been off of Remicade for 6 weeks, and off all other Biologics for 4 weeks.
• ≥18 yrs old
• Diagnosis of Spondyloarthritis (SpA) (per the Assessment of SpondyloArthritis(ASAS) criteria and having sacroiliitis as confirmed by radiographs or MRI at baseline), with psoriatic arthritis (PsA) (per the ASAS or Classification Criteria for Psoriatic Arthritis(CASPAR) criteria).
• Patients must have evidence of sacroiliitis either by radiograph or MRI, or must have evidence of spine inflammation confirmed by radiographs or spine MRI

You may not qualify if:

• Patients currently receiving biologic therapy (e.g. adalimumab, etanercept, infliximab, golimumab, certolizumab pegol)
• Diagnosis of a systemic rheumatic disease or crystalline arthritis (i.e. Rheumatoid Arthritis(RA), Systemic Lupus Erythematosus(SLE), systemic sclerosis, gout, pseudogout, Lyme arthritis, reactive arthritis, viral arthritis)
• Pregnant or nursing
• Unable to give informed consent
• Lack of fluency in English. Unfortunately, we do not have the financial resources to offer full translation services
• Unwilling or unable to be followed as part of routine care

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Links

• Hospital for Special Surgery
• Principal Investigator, Vivian Bykerk MD

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples

MeSH Terms

Conditions

Spondylarthritis; Spondylitis, Ankylosing; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: October 25, 2013
• Study Start: January 1, 2013
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-01

Locations

US (1)