Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)CESPICNCT05960864
Chinese Spondyloarthritis Inception Cohort (CESPIC)
An observational study of Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA) and Non-radiographic Axial Spondyloarthritis (Nr-axSpA), run by Southwest Hospital, China.
Trial summary
The Chinese Spondyloarthritis Inception cohort (CESPIC) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in China on patients with early SpA including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial SpA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA), Non-radiographic Axial Spondyloarthritis (Nr-axSpA), Axial Psoriatic Arthritis (axPsA)
- What is being tested?
- Celecoxib
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Aug 2030
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients included in CESPIC are required to have a definite clinical diagnosis of axial SpA / juvenile SpA (currently only adult patients with radiographic axial SpA = ankylosing spondylitis - AS are recruited) or a definite diagnosis of Crohn's disease or a definite diagnosis of acute anterior uveitis or a definite diagnosis of psoriatic arthritis with axial involvement or a definite diagnosis of reactive arthritis.
Who may be able to join
- Crohn's disease. Acute anterior uveitis. Psoriatic arthritis with axial involvement. Reactive arthritis.
Who cannot join
- Infections, Malignancies, Major cardiovascular events, Lower intestinal perforations Other adverse events
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chinese Spondyloarthritis Inception Cohort
The Chinese Spondyloarthritis Inception cohort (CESPIC) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in China on patients with early SpA including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial SpA. The objectives of CESPIC are to learn about the course of SpA during the very early stage of the disease, to appropriately assess the outcome including radiographic progression of patients after several years of follow-up, to identify outcome predictors, to assess quality of life, function, and costs (direct and indirect costs). CESPIC has been recently expanded to recruit patients with other forms of SpA / conditions associated with SpA: reactive arthritis, acute anterior uveitis, Crohn's disease as well as with psoriasis / axial psoriatic arthritis.
- Conditions
- Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA), Non-radiographic Axial Spondyloarthritis (Nr-axSpA), Axial Psoriatic Arthritis (axPsA), Acute Anterior Uveitis (AAU), Crohn Disease (CD), Ulcerative Colitis (UC)
- Being tested
- Celecoxib
- Medical subject headings
- Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis, Uveitis, Anterior, Crohn Disease, Colitis, Ulcerative, Arthritis, Reactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
If we find any behavior that affects the safety of patients in the experiment, we will stop
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing spondylitis | Ankylosing spondylitis according to the modified New York criteria or with the clinical diagnosis of AS/r-axSpA fulfilling the ASAS Classification Criteria AND the mNY criteria plus having the indiaction for starting a bDMARD therapy according to the treating rheumatologist Receives: Drug: Celecoxib | |
| Non-radiographic axial spondyloarthritis | Patients with clinical characteristics of axial SpA but not fulfilling the modified New York criteria for which radiographic sacroiliitis is essential or with the clinical diagnosis of nr-axSpA fulfilling the ASAS Classification Criteria not fulfilling the mNY criteria and the indiaction for starting a bDMARD therapy according to the treating rheumatologist Receives: Drug: Celecoxib | |
| Juvenile spondyloarthritis | Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis). Receives: Drug: Celecoxib | |
| Crohn's disease | Patients with Crohn's disease Receives: Drug: Celecoxib | |
| Acute anterior uveitis | Patients with acute anterior uveitis Receives: Drug: Celecoxib | |
| Axial psoriatic arthritis | Patients with the clinical diagnosis of psoriatic arthritis with axial involvement (sacroiliac joints and/or spine) (axPsA) Receives: Drug: Celecoxib | |
| Reactive arthritis | Patients with reactive arthritis Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
BASDAI
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) disease activity questionnaire contains six questions regarding subjective symptoms
Measured: baseline
ASDAS
The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite index to assess disease activity in Ankylosing Spondylitis (AS)1. It combines five disease activity variables with only partial overlap, resulting in one single score with better truth (validity), enhanced discriminative capacity and improved sensitivity to change as compared to single-item variables
Measured: baseline
CRP
A c-reactive protein test measures the level of c-reactive protein (CRP) in a sample of your blood. CRP is a protein that your liver makes. Normally, you have low levels of c-reactive protein in your blood. Your liver releases more CRP into your bloodstream if you have inflammation in your body. High levels of CRP may mean you have a serious health condition that causes inflammation.
Measured: baseline
BASMI
BASMI was created to help clinicians accurately assess axial status (through five measurements) of individuals suffering from Ankylosing Spondylitis. The measurements are then interpreted to derive a metrology index to define clinically significant changes in spinal mobility.
Measured: baseline
BASFI
The Bath Ankylosing Spondylitis Functional Index is to determine the degree of functional limitation in patients with the inflammatory autoimmune disease Ankylosing Spondylitis (AS).
Measured: baseline
Secondary outcomes (2)
ASAS20
The ASAS Response Criteria (ASAS 20) is defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function (BASFI), and Inflammation (last 2 questions of BASDAI).
Measured: baseline
ASAS40
The ASAS Response Criteria (ASAS 20) is defined as an improvement of at least 40% and an absolute improvement of at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function (BASFI), and Inflammation (last 2 questions of BASDAI).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study startSep 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)Studies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangxing Chen, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960864
- Sponsor's protocol ID
- CESPIC
- Acronym
- CESPIC
- Status last verified
- Apr 2024
- First submitted
- 6 Jul 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Chinese Spondyloarthritis Inception cohort (CESPIC) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in China on patients with early SpA including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial SpA. The objectives of CESPIC are to learn about the course of SpA during the very early stage of the disease, to appropriately assess the outcome including radiographic progression of patients after several years of follow-up, to identify outcome predictors, to assess quality of life, function, and costs (direct and indirect costs). CESPIC has been recently expanded to recruit patients with other forms of SpA / conditions associated with SpA: reactive arthritis, acute anterior uveitis, Crohn's disease as well as with psoriasis / axial psoriatic arthritis.
Publications
Rudwaleit M, Haibel H, Baraliakos X, Listing J, Marker-Hermann E, Zeidler H, Braun J, Sieper J. The early disease stage in axial spondylarthritis: results from the German Spondyloarthritis Inception Cohort. Arthritis Rheum. 2009 Mar;60(3):717-27. doi: 10.1002/art.24483.
PubMed 19248087Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010 Jul;69(7):1338-41. doi: 10.1136/ard.2009.120139. Epub 2010 May 24.
PubMed 20498207Poddubnyy D, Rudwaleit M, Haibel H, Listing J, Marker-Hermann E, Zeidler H, Braun J, Sieper J. Rates and predictors of radiographic sacroiliitis progression over 2 years in patients with axial spondyloarthritis. Ann Rheum Dis. 2011 Aug;70(8):1369-74. doi: 10.1136/ard.2010.145995. Epub 2011 May 27.
PubMed 21622969Poddubnyy DA, Marker-Hermann E, Kaluza-Schilling W, Zeidler H, Braun J, Listing J, Sieper J, Rudwaleit M. Relation of HLA-B27, tumor necrosis factor-alpha promoter gene polymorphisms, and T cell cytokine production in ankylosing spondylitis -- a comprehensive genotype-phenotype analysis from an observational cohort. J Rheumatol. 2011 Nov;38(11):2436-41. doi: 10.3899/jrheum.110130. Epub 2011 Sep 1.
PubMed 21885496