Chinese Spondyloarthritis Inception Cohort
| Registry | NCT05960864, acronym CESPIC |
|---|
| Status | Not yet recruiting |
|---|
| Study type | Observational |
|---|
| Enrollment | 1000 (Estimated) |
|---|
| Sponsor | Southwest Hospital, China (Other) |
|---|
| 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), Reactive Arthritis (ReA) |
|---|
| Interventions | Celecoxib (Drug) |
|---|
| Dates | start 2024-09-01 (estimated), primary completion 2025-08-01 (estimated), completion 2030-08-01 (estimated), first posted 2023-07-27, last updated 2024-04-17 |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA) All trials for Non-radiographic Axial Spondyloarthritis (Nr-axSpA) All trials of Celecoxib
-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. 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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Ankylosing spondylitis | | Drug: Celecoxib | 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 |
| Non-radiographic axial spondyloarthritis | | Drug: Celecoxib | 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 |
| Juvenile spondyloarthritis | | Drug: Celecoxib | Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis). |
| Crohn's disease | | Drug: Celecoxib | Patients with Crohn's disease |
| Acute anterior uveitis | | Drug: Celecoxib | Patients with acute anterior uveitis |
| Axial psoriatic arthritis | | Drug: Celecoxib | Patients with the clinical diagnosis of psoriatic arthritis with axial involvement (sacroiliac joints and/or spine) (axPsA) |
| Reactive arthritis | | Drug: Celecoxib | Patients with reactive arthritis |
- Celecoxib (Drug): If we find any behavior that affects the safety of patients in the experiment, we will stop
+Outcome measures
Primary outcomes
- BASDAI [baseline]: The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) disease activity questionnaire contains six questions regarding subjective symptoms
- ASDAS [baseline]: 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
- CRP [baseline]: 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.
- BASMI [baseline]: 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.
- BASFI [baseline]: The Bath Ankylosing Spondylitis Functional Index is to determine the degree of functional limitation in patients with the inflammatory autoimmune disease Ankylosing Spondylitis (AS).
Secondary outcomes
- ASAS20 [baseline]: 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).
- ASAS40 [baseline]: 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).
+Eligibility
Sex: All
Inclusion Criteria:
Crohn's disease. Acute anterior uveitis. Psoriatic arthritis with axial involvement. Reactive arthritis.
Exclusion Criteria:
Infections, Malignancies, Major cardiovascular events, Lower intestinal perforations Other adverse events
+Publications
- Results publication: 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. PMID 19248087
- Results publication: Poddubnyy 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. PMID 20498207
- Results publication: Poddubnyy 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. PMID 21622969
- Results publication: Poddubnyy 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. PMID 21885496