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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Inflammation Ankylosing Spondylitis
Intervention	Drug: celebrex Drug: Enbrel Drug: Enbrel plus Celebrex
Phase	Phase 4
Sponsor	Sun Yat-sen University
Responsible Party	Sun Yat-sen University
ClinicalTrials.gov Identifier	NCT01934933
First Received	August 17, 2013
Last Updated	August 29, 2013
Last verified	August 2013

Tracking Information[ + expand ][ + ]

First Received Date	August 17, 2013
Last Updated Date	August 29, 2013
Start Date	August 2013
Estimated Primary Completion Date	August 2015
Current Primary Outcome Measures	the SPARCC score of spine and SI joint [Time Frame: 24th weeks] [Designated as safety issue: No]the MRI SPARCC score of spine and SI joint on 24th week mSASSS score of spine [Time Frame: 52th week] [Designated as safety issue: No]the mSASSS score of spine on 52th week ASAS20 response rate [Time Frame: 24th week] [Designated as safety issue: No]ASAS20 response rate on 24th week
Current Secondary Outcome Measures	ASAS20 response [Time Frame: 24th week] [Designated as safety issue: No] ASAS40 response [Time Frame: 24th week] [Designated as safety issue: No] ASAS70 response [Time Frame: 24th week] [Designated as safety issue: No] ASAS5/6 response [Time Frame: 24th week] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Delaying Ossification and Improving Inflammation of Celebrex Plus/or Enbrel Treatment on Active Ankylosing Spondylitis
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
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Inflammation Ankylosing Spondylitis
Intervention	Drug: celebrex Drug: Enbrel Drug: Enbrel plus Celebrex
Study Arm (s)	Active Comparator: celebrex celebrex capsule, 0.2 gram bid Active Comparator: Enbrel etanercept injection, 25mg per injection,50mg/week Active Comparator: Enbrel plus Celebrex 50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	225
Estimated Completion Date	August 2015
Estimated Primary Completion Date	March 2015
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Jieruo Gu, Prof +8620-85252055 gujieruo@163.com
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT01934933
Other Study ID Numbers	[2013]2-93
Has Data Monitoring Committee	Yes
Information Provided By	Sun Yat-sen University
Study Sponsor	Sun Yat-sen University
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	August 2013

Locations[ + expand ][ + ]

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