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NCT Number: NCT05960864

Chinese Spondyloarthritis Inception Cohort (CESPIC)

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.

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Key information

Conditions

Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA) Acute Anterior Uveitis (AAU) Ankylosis Arthritis Arthritis, Infectious Arthritis, Reactive Axial Psoriatic Arthritis (axPsA) Axial Spondyloarthritis Bone Diseases Chronic Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Disease Attributes Eye Diseases Gastroenteritis Gastrointestinal Diseases Infections Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Non-Radiographic Axial Spondyloarthritis Non-radiographic Axial Spondyloarthritis (Nr-axSpA) Panuveitis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders Reactive Arthritis (ReA) Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Ulcerative Colitis (UC) Uveal Diseases Uveitis Uveitis, Anterior

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

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

Primary outcomes

  1. BASDAI

    Time frame: baseline

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

  2. ASDAS

    Time frame: 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

  3. CRP

    Time frame: 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.

  4. BASMI

    Time frame: 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.

  5. BASFI

    Time frame: 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 outcomes

  1. ASAS20

    Time frame: 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).

  2. ASAS40

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Guangxing Chen, Ph.D.

CONTACT

[email protected]

18623108787

Sponsors and collaborators

Lead sponsor

Southwest Hospital, China

Other

Registry information

Official study title

Chinese Spondyloarthritis Inception Cohort

Acronym: CESPIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Jul 27, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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