Chinese Spondyloarthritis Inception Cohort (CESPIC)

NCT05960864 | Not Yet Recruiting FDA Drug

• 1 other identifier: CESPIC
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

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)

Outcome Measures

Primary Outcomes (5)

• BASDAI

  The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) disease activity questionnaire contains six questions regarding subjective symptoms

  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

  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.

  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.

  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).

  baseline

Secondary Outcomes (2)

• ASAS20

  baseline

• ASAS40

  baseline

Study Arms (7)

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

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

Drug: Celecoxib

Juvenile spondyloarthritis

Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis).

Drug: Celecoxib

Crohn's disease

Patients with Crohn's disease

Drug: Celecoxib

Acute anterior uveitis

Patients with acute anterior uveitis

Drug: Celecoxib

Axial psoriatic arthritis

Patients with the clinical diagnosis of psoriatic arthritis with axial involvement (sacroiliac joints and/or spine) (axPsA)

Drug: Celecoxib

Reactive arthritis

Patients with reactive arthritis

Drug: Celecoxib

Interventions

Celecoxib DRUG

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

Acute anterior uveitis; Ankylosing spondylitis; Axial psoriatic arthritis; Crohn's disease; Juvenile spondyloarthritis; Non-radiographic axial spondyloarthritis; Reactive arthritis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Crohn's disease. Acute anterior uveitis. Psoriatic arthritis with axial involvement. Reactive arthritis.

You may not qualify if:

• Infections, Malignancies, Major cardiovascular events, Lower intestinal perforations Other adverse events

Sponsors & Collaborators

• Southwest Hospital, China: lead

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis; Uveitis, Anterior; Crohn Disease; Colitis, Ulcerative; Arthritis, Reactive

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Arthritis, Infectious; Infections; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Guangxing Chen, Ph.D.

CONTACT

18623108787; chjoint@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR