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Delaying Ossification and Improving Inflammation of Celebrex Plus/or Enbrel Treatment on Active Ankylosing Spondylitis

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation; Ankylosing Spondylitis

Intervention: celebrex (Drug); Enbrel (Drug); Enbrel plus Celebrex (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sun Yat-sen University

Overall contact:
Jieruo Gu, Prof, Phone: +8620-85252055, Email: gujieruo@163.com


This is a prospective, open-label trial to evaluate efficacy for delaying ossification and improving inflammation of celebrex treatment on active ankylosing spondylitis (AS). Subjects will be randomly divided into three groups (Enbrel group, Celebrex group and Enbrel plus Celebrex group) and receive responsable treatment for 54 weeks. Clinical response assessment, laboratory assessment and radiology assessment will be recorded. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score and the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) of spine and sacroiliac(SI) joint, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate. Secondary Endpoints include ASAS20, ASAS40, ASAS70 and ASAS5/6 response rate on each visit and other clinical indexes.

Clinical Details

Official title: An Open Clinical Trial to Assess Efficacy for Delaying Ossification and Improving Inflammation of Celebrex Plus/or Enbrel Treatment on Active Ankylosing Spondylitis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

the SPARCC score of spine and SI joint

mSASSS score of spine

ASAS20 response rate

Secondary outcome:

ASAS20 response

ASAS40 response

ASAS70 response

ASAS5/6 response


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- 18 to 65 years

- Meet 1984 NewYork modified criteria for AS

- BASDAI≥4 or ASDAS score ≥ 2. 1

- CRP>6 mg/L or ESR>28 mm/h

- Syndesmophyte quantity ≥2 and <16 of spine

- Sexually active women of childbearing potential must agree and commit to use a

medically accepted form of contraception

- No active or latent tuberculosis infection.

Exclusion Criteria:

- Pregnant or breastfeeding women

- current or previous history of psoriasis or inflammatory bowel disease.

- infection with clinical significance within 24 weeks before screening

- receipt any bio-agents treatment within 12 weeks before screening

- corticosteroids intra-articular injections in last 3 months before the trial

- Significant concurrent medical events including: Gastrointestinal ulcer, myocardial

infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.

- Alcohol and drug abuse

Locations and Contacts

Jieruo Gu, Prof, Phone: +8620-85252055, Email: gujieruo@163.com

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China; Recruiting
Jieruo Gu, Prof, Phone: +8620-85252055, Email: gujieruo@163.com
Jieruo Gu, Prof, Principal Investigator
Additional Information

Starting date: August 2013
Last updated: May 19, 2014

Page last updated: August 20, 2015

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