Clinical trial NCT01934933: Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
Official title: A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: inflammation
etanercept
celecoxib
ankylsoing spondylitis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the SPARCC score of spine and SI joint
timeFrame: 52th weeks
measure: ASAS20 response rate
timeFrame: 52th week
Secondary outcomes:
measure: ASAS40 response rate
timeFrame: 52th week
measure: ASAS70 response
timeFrame: 52th week
measure: ASDAS
timeFrame: 52th week
measure: mSASSS score of spine
timeFrame: 52th week
measure: Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS)
timeFrame: 52th week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Rheumatology ,Third Affiliated Hospital of Sun Yat-sen University
name: Jieruo Gu, Prof
role: STUDY_DIRECTOR
References:
citation: Tu L, Zhao M, Wang X, Kong Q, Chen Z, Wei Q, Li Q, Yu Q, Ye Z, Cao S, Lin Z, Liao Z, Lv Q, Qi J, Jin O, Pan Y, Gu J. Etanercept/celecoxib on improving MRI inflammation of active ankylosing spondylitis: A multicenter, open-label, randomized clinical trial. Front Immunol. 2022 Aug 26;13:967658. doi: 10.3389/fimmu.2022.967658. eCollection 2022.