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
Summary
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 jointmSASSS score of spine ASAS20 response rate
Secondary outcome: ASAS20 responseASAS40 response ASAS70 response ASAS5/6 response
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
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