Ankylosing Spondylitis
Conditions
Keywords
inflammation, etanercept, celecoxib, ankylsoing spondylitis
Brief summary
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
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.
Interventions
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the SPARCC score of spine and SI joint | 52th weeks | the MRI SPARCC score of spine and SI joint on 52th week |
| ASAS20 response rate | 52th week | ASAS20 response rate on 52th week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASDAS | 52th week | ASDAS major improvement ASDAS clinically important improvement on 52th week |
| ASAS40 response rate | 52th week | ASAS40 response rate on 52th week |
| Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS) | 52th week | the MRI SPARCC SSS score of spine on 52th week |
| mSASSS score of spine | 52th week | the mSASSS score of spine on 52th week |
| ASAS70 response | 52th week | ASAS70 response rate on 52th week |
Countries
China
Outcome results
None listed