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TNF- α receptor inhibitors have been used widely in practice and are well developed in China. Anbainuo is a bio-similar recombinant TNF-α receptor: IgG Fc fusion protein, approved in 2015. Up to now, Anbainuo is well applied in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Although the phase II and III clinical trials both indicated that Anbainuo can effectively control the disease activity with good tolerance and safety in RA and AS patients, there is no sufficient clinical evidence in the real world. Thus, the objective of this study is to evaluate, under the actual conditions of use, dosing patterns of Anbainuo. Investigators plan to recruit 1000 adult patients with RA or AS and to follow them for 48 weeks. It is hypothesized that this study would reflect real clinical conditions (efficacy and safety assessment) of using Anbainuo in RA and AS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rheumatoid arthritis patients | subjects with rheumatoid arthritis would be administered with recombinant TNF-α receptor: IgG Fc fusion protein (Anbainuo)50 mg peer week for 3 to 6 months until reaching clinical remission or low disease activity. Then the application of Anbainuo would be continued for 6 months. If the subjects did not reach clinical remission or low disease activity in 6 months, the treatment should be considered as invalid. |
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| ankylosing spondylitis patients | subjects with ankylosing spondylitis would be administered with recombinant TNF-α receptor: IgG Fc fusion protein (Anbainuo)50 mg peer week for 3 to 6 months until reaching clinical remission or low disease activity. Then the application of Anbainuo would be continued for 6 months. If the subjects did not reach clinical remission or low disease activity in 6 months, the treatment should be considered as invalid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant TNF-α receptor: IgG Fc fusion protein | Drug | 50mg weekly |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants achieving clinical remission defined as a DAS28 ≥1.2 | The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement. | Up to week 48 |
| Percent of participants achieving bath ankylosing spondylitis disease activity index (BASDAI) 50 response. | BASDAI subject assessment of discomfort, pain and fatigue was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very severe. BASDAI 50 response defined as at least a 50 percent (%) improvement (decrease) from baseline to observation (last observation carried forward) in the BASDAI. Baseline score minus score at observation divided by Baseline score * 100 = >=50%. | Up to week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From baseline in the modified total Sharp score to week 48 | he modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing. |
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Inclusion Criteria:
Exclusion Criteria:
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RA and AS patients from 30 centers (hospital) in China.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C582199 | Anbainuo protein, human |
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| baseline and week 48 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |