Chinese Spondyloarthritis Inception Cohort (CESPIC)

NCT ID: NCT05960864

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2030-08-31

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Celecoxib

Intervention Type: DRUG

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

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

Celecoxib

Intervention Type: DRUG

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

Juvenile spondyloarthritis

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

Celecoxib

Intervention Type: DRUG

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

Crohn's disease

Patients with Crohn's disease

Celecoxib

Intervention Type: DRUG

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

Acute anterior uveitis

Patients with acute anterior uveitis

Celecoxib

Intervention Type: DRUG

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

Axial psoriatic arthritis

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

Celecoxib

Intervention Type: DRUG

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

Reactive arthritis

Patients with reactive arthritis

Celecoxib

Intervention Type: DRUG

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

Interventions

Celecoxib

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

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Guangxing Chen

Professor, Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Guangxing Chen, Ph.D.

Role: CONTACT

chjoint@hotmail.com

18623108787

References

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.

Reference Type: RESULT

PMID: 19248087 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20498207 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21622969 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21885496 (View on PubMed)

Other Identifiers

CESPIC

Identifier Type: -

Identifier Source: org_study_id