Clinical Trial Details

NCT ID: NCT01969188
Date Last Changed: June 12, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study for the treatment of Spondyloarthritis

Research Study Title

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

Purpose

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.

To Learn more

Recruitment Details

Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Hospital for Special Surgery, New York
Duration
59 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Site Locations (1)

Country State City Zip Facility and Contact
United States New York New York 10021 Hospital for Special Surgery
Vivian P Bykerk, MD
212-774-7520
bykerkv@hss.edu

Susan M Goodman, MD
Sub-Investigator

Vivian P Bykerk, MD
Principal Investigator

Lisa A Mandl, MD
Sub-Investigator

Mary K Crow, MD
Sub-Investigator

Sergio Schwartzman, MD
Sub-Investigator

Contact

Caroline Reidy, MPH
6467146307
E-mail:

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