Chinese Spondyloarthritis Inception Cohort (CESPIC)

Ulcerative Colitis (UC) Clinical Trial

— CESPIC  

Official title:

Chinese Spondyloarthritis Inception Cohort

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960864
• Other study ID #: CESPIC
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: August 2030

Study information

• Verified date: April 2024
• Source: Southwest Hospital, China
• Contact: Guangxing Chen, Ph.D.
• Phone: 18623108787
• Email: chjoint[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: August 2030
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Reactive
• Axial Spondyloarthritis
• Crohn Disease
• Crohn Disease (CD)
• Iridocyclitis
• Non-Radiographic Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing
• Ulcerative Colitis (UC)
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• Celecoxib
If we find any behavior that affects the safety of patients in the experiment, we will stop

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

References & Publications (4)

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: — View Citation

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 comprehen — View Citation

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- — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BASDAI	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) disease activity questionnaire contains six questions regarding subjective symptoms	baseline
Primary	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	baseline
Primary	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.	baseline
Primary	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.	baseline
Primary	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).	baseline
Secondary	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).	baseline
Secondary	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).	baseline