Chinese Spondyloarthritis Inception Cohort (CESPIC)

Study Overview
=================
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.

Official Title
-----------------
Chinese Spondyloarthritis Inception Cohort

Conditions
-----------------
Crohn Disease (CD), Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA), Non-radiographic Axial Spondyloarthritis (Nr-axSpA), Axial Psoriatic Arthritis (axPsA), Acute Anterior Uveitis (AAU), Ulcerative Colitis (UC), Reactive Arthritis (ReA)

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ankylosing spondylitis<br>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<br>* If we find any behavior that affects the safety of patients in the experiment, we will stop<br>|
| Non-radiographic axial spondyloarthritis<br>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<br>* If we find any behavior that affects the safety of patients in the experiment, we will stop<br>|
| Juvenile spondyloarthritis<br>Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis). | Drug: Celecoxib<br>* If we find any behavior that affects the safety of patients in the experiment, we will stop<br>|
| Crohn's disease<br>Patients with Crohn's disease | Drug: Celecoxib<br>* If we find any behavior that affects the safety of patients in the experiment, we will stop<br>|
| Acute anterior uveitis<br>Patients with acute anterior uveitis | Drug: Celecoxib<br>* If we find any behavior that affects the safety of patients in the experiment, we will stop<br>|
| Axial psoriatic arthritis<br>Patients with the clinical diagnosis of psoriatic arthritis with axial involvement (sacroiliac joints and/or spine) (axPsA) | Drug: Celecoxib<br>* If we find any behavior that affects the safety of patients in the experiment, we will stop<br>|
| Reactive arthritis<br>Patients with reactive arthritis | Drug: Celecoxib<br>* If we find any behavior that affects the safety of patients in the experiment, we will stop<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |