Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

Study Overview
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Brief Summary
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This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS). Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib 200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.

Detailed Description
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A multi-center, open label, randomized clinical trial evaluating the effectiveness and safety of etanercept and celecoxib alone/combined treatment will be conducted on active ankylosing spondylitis (AS) patients. Disease activity is defined as fulfilling three aspects below: BASDAI ≥ 4 or ASDAS≥ 2.1；CRP>6 mg/L or ESR 28 mm/1st hour；more than 2 and less than 16 syndesmophyts between cervical spine and lumber spine detected by X-ray. All patients were randomly assigned in a 1:1:1 ratio to one of the three treatment groups：celecoxib 200mg bid，etanercept 50mg qw and combined therapy for 52 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS) 20 response rate at 52 weeks. Key secondary Endpoints include the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS), BASDAI, ASDAS, ASAS40, ASAS70 and ASAS5/6 response rate at 52 weeks.

Official Title
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A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: celebrex
* Drug: Enbrel
* Drug: Enbrel plus Celebrex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: celebrex<br>celebrex capsule, 0.2 gram bid, 52 weeks | Drug: celebrex<br> <br> * Other names: celecoxib;|
| Active Comparator: Enbrel<br>etanercept injection, 25mg per injection, 50mg/week, 52 weeks | Drug: Enbrel<br> <br> * Other names: etanercept;|
| Active Comparator: Enbrel plus Celebrex<br>50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 weeks | Drug: Enbrel plus Celebrex<br> <br> * Other names: celecoxib plus etanercept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the SPARCC score of spine and SI joint | the MRI SPARCC score of spine and SI joint on 52th week | 52th weeks | 
| ASAS20 response rate | ASAS20 response rate on 52th week | 52th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASAS40 response rate | ASAS40 response rate on 52th week | 52th week | 
| ASAS70 response | ASAS70 response rate on 52th week | 52th week | 
| ASDAS | ASDAS major improvement ASDAS clinically important improvement on 52th week | 52th week | 
| mSASSS score of spine | the mSASSS score of spine on 52th week | 52th week | 
| Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS) | the MRI SPARCC SSS score of spine on 52th week | 52th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, etanercept, celecoxib, ankylsoing spondylitis