Chinese Spondyloarthritis Inception Cohort (CESPIC)

Sponsor

Southwest Hospital, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05960864

Collaborator

(none)

1,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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)	Drug: Celecoxib

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Chinese Spondyloarthritis Inception Cohort

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
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 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	Drug: Celecoxib 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).	Drug: Celecoxib 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	Drug: Celecoxib 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	Drug: Celecoxib 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)	Drug: Celecoxib If we find any behavior that affects the safety of patients in the experiment, we will stop
Reactive arthritis Patients with reactive arthritis	Drug: Celecoxib If we find any behavior that affects the safety of patients in the experiment, we will stop

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).