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Also known as Adalimumab - GP2017
Adalimumab- GP2017 · 1 trial · 1 indication
Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity (GDA) or general health (GH), values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \< 2.6 corresponds to remission DAS28-CRP = 0.56 \* sqrt(tender28) + 0.28\* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* GDA or GH + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm
| Arm | Type | Description |
|---|---|---|
| GP2017 | EXPERIMENTAL | Group 1 will receive treatment with 40mg GP2017 (Adalimumab - GP2017) by subcutaneous injection every other week up to 24 weeks (Study Period 1) at which patients achieving at least a moderate clinical response continue treatment with 40mg GP2017 subcutaneous injection every other week up to 48 weeks (Study Period 2). |
| US Licensed Humira | ACTIVE_COMPARATOR | Group 2 will receive treatment with 40mg Humira® (Adalimumab - US licensed Humira®) by subcutaneous injection every other week up to 24 weeks (Study Period 1) at which patients achieving at least a moderate clinical response will be switched to treatment with 40mg GP2017 subcutaneous injection every other week up to 48 weeks (Study Period 2). |
| Name | Type | Description |
|---|---|---|
| Adalimumab - GP2017 | BIOLOGICAL | Adalimumab - GP2017 |
| Adalimumab - US licensed Humira | BIOLOGICAL | Adalimumab - US licensed Humira |
Inclusion Criteria: 1. Patients must have been diagnosed with RA ≥ 6 months prior to screening 2. Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening 3. Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal 4. Patients must have ...
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