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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01934933 |
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Date of registration:
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17/08/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
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Scientific 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 |
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Date of first enrolment:
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September 24, 2014 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01934933 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Jieruo Gu, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Rheumatology ,Third Affiliated Hospital of Sun Yat-sen University |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Enbrel
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Drug: celebrex
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Drug: Enbrel plus Celebrex
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Primary Outcome(s)
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ASAS20 response rate
[Time Frame: 52th week]
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the SPARCC score of spine and SI joint
[Time Frame: 52th weeks]
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Secondary Outcome(s)
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mSASSS score of spine
[Time Frame: 52th week]
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ASDAS
[Time Frame: 52th week]
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Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS)
[Time Frame: 52th week]
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ASAS70 response
[Time Frame: 52th week]
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ASAS40 response rate
[Time Frame: 52th week]
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Secondary ID(s)
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[2013]2-93
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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