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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| celebrex | Active Comparator | celebrex capsule, 0.2 gram bid, 52 weeks |
|
| Enbrel | Active Comparator | etanercept injection, 25mg per injection, 50mg/week, 52 weeks |
|
| Enbrel plus Celebrex | Active Comparator | 50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celebrex | Drug |
|
| |
| Enbrel |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jieruo Gu, Prof | Department of Rheumatology ,Third Affiliated Hospital of Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36091030 | Derived | 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. |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Drug |
|
|
| Enbrel plus Celebrex | Drug |
|
|
| 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 |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |