SpondyloarthritisNCT01969188
A Study of Novel Immune Modulating Biomarkers in Patients With Spondyloarthritis With Axial Involvement
An observational study of Spondyloarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spondyloarthritis
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 18 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a confirmed diagnosis of spondloarthritis with axial involvement and no biologic treatment in most recent three months (see inclusion criteria).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
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.
Read the detailed description
The condition to be studied is Spondyloarthritis (SpA). The investigators will gather a cohort of patients with variants of SpA (n = 70), including Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) who have axial disease and fully characterize disease activity. Care guidelines suggest that these patients are seen at least twice within the first year with annual visits thereafter. Radiographs are desirable to assess disease progression, but are not always required. Treatment options for both PsA and AS patients include non-steroidal anti-inflammatory drugs (NSAIDs), steroid injections, disease modifying anti rheumatic drugs (DMARDs) and biologics (i.e. tumor necrosis factor inhibitors aka TNF inhibitors or TNFi's). The cohort of patients eligible for enrollment in this study would be those patients who for the preceding 6 weeks have not received biologic treatment such as infliximab,and who for the preceding 4 weeks have not received biologic treatments such as adalimumab, etanercept,golimumab, certolizumab pegol and other biologic therapies.
Subjects will be evaluated 4 times over two years: at enrollment, 24 weeks, 52 weeks and 104 weeks (with a 12 week window around each visit). Usual care for patients with SpA would include regular assessments of pain, function and mobility, assessments of spine and joint motion, joint swelling and tenderness with treatment changes at each follow up visit to reduce pain, improve function, address adverse events to medications and enhance spinal mobility. Interventions might include physical therapy, analgesics, NSAIDs, DMARDs or biologic therapies. The investigator would not assign specific interventions to the subjects of the study. All of this would be recorded.
Specific clinical information will be gathered at each visit using validated indexes and data collection instruments, including disease activity [using the Bath AS Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS)], function (using the Bath AS Functional Index (BASFI), measure joint/ligament involvement, measuring tender and swollen joint counts, dactylitis, enthesitis (as quantified using the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index and spine involvement (measured as range of movement in the spine and hips using the Bath AS Metrology Index (BASMI).
- Conditions
- Spondyloarthritis
- Keywords
- spondyloarthritis, ankylosing spondylitis, psoriatic arthritis
- Medical subject headings
- Spondylarthritis, Spondylitis, Ankylosing, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SpA in RA | Patients with SpA with psoriatic arthritis (PsA), ankylosing spondylitis (AS), no biologic therapy for 3 months, over 18 yrs old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
(a) A secondary outcome will be the difference in peripheral blood IL-23R levels in patients whose ASDAS improves by at least 1.1 over 1 year and will be measured at the end of the first year and again at the end of the two-year study period. These patients will be referred to as "responders" to usual care. (We will also look at changes in level of IL-23R over 2 years in responders vs. non responders). A change of at least 1.1 is the minimally clinically important difference.
- We will evaluate the correlation of other immune modulators and inflammatory cytokines such as, TNF, IL-1, IL-6, IL-17, IL-22, and IL-21 and disease activity in patients who are followed serially with standard disease activity measures (ASDAS, BASDAI), function (BASFI), and enthesitis (MASES)(1, 2).
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startJan 2013
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969188
- Sponsor's protocol ID
- 2014-227
- Status last verified
- Jan 2025
- First submitted
- 14 Jun 2013
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Novel Immune Modulating Biomarkers in Patients With Spondyloarthritis With Axial Involvement
- ClinicalTrials.gov ID
- NCT01969188
- Acronym / sponsor ID
- 2014-227
- Conditions
- Spondyloarthritis
- Keywords
- spondyloarthritis, ankylosing spondylitis, psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jan 2013
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The condition to be studied is Spondyloarthritis (SpA). The investigators will gather a cohort of patients with variants of SpA (n = 70), including Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) who have axial disease and fully characterize disease activity. Care guidelines suggest that these patients are seen at least twice within the first year with annual visits thereafter. Radiographs are desirable to assess disease progression, but are not always required. Treatment options for both PsA and AS patients include non-steroidal anti-inflammatory drugs (NSAIDs), steroid injections, disease modifying anti rheumatic drugs (DMARDs) and biologics (i.e. tumor necrosis factor inhibitors aka TNF inhibitors or TNFi's). The cohort of patients eligible for enrollment in this study would be those patients who for the preceding 6 weeks have not received biologic treatment such as infliximab,and who for the preceding 4 weeks have not received biologic treatments such as adalimumab, etanercept,golimumab, certolizumab pegol and other biologic therapies.
Subjects will be evaluated 4 times over two years: at enrollment, 24 weeks, 52 weeks and 104 weeks (with a 12 week window around each visit). Usual care for patients with SpA would include regular assessments of pain, function and mobility, assessments of spine and joint motion, joint swelling and tenderness with treatment changes at each follow up visit to reduce pain, improve function, address adverse events to medications and enhance spinal mobility. Interventions might include physical therapy, analgesics, NSAIDs, DMARDs or biologic therapies. The investigator would not assign specific interventions to the subjects of the study. All of this would be recorded.
Specific clinical information will be gathered at each visit using validated indexes and data collection instruments, including disease activity [using the Bath AS Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS)], function (using the Bath AS Functional Index (BASFI), measure joint/ligament involvement, measuring tender and swollen joint counts, dactylitis, enthesitis (as quantified using the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index and spine involvement (measured as range of movement in the spine and hips using the Bath AS Metrology Index (BASMI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpA in RA | – | –Patients with SpA with psoriatic arthritis (PsA), ankylosing spondylitis (AS), no biologic therapy for 3 months, over 18 yrs old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of spondloarthritis with axial involvement and no biologic treatment in most recent three months (see inclusion criteria).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between the change in IL-23R(Interleukin-23 receptor) levels and disease activity at one year and two years.
Time frame: 12 months and 24 months.
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.
1 secondary outcome
Difference in peripheral blood IL-23R levels in "responders", and correlation of other immune modulators and inflammatory cytokines
Time frame: 12 months and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Hospital for Special SurgeryLink provided by the sponsor.
- Principal Investigator, Vivian Bykerk MDLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the change in IL-23R(Interleukin-23 receptor) levels and disease activity at one year and two years. (time frame: 12 months and 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.