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Also known as GP2015 Etanercept, Etanercept
GP2015 · 2 trials · 2 indications
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, 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 + 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
The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
| Arm | Type | Description |
|---|---|---|
| 50mg GP2015 | EXPERIMENTAL | Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). |
| 50mg EU-authorized Enbrel | ACTIVE_COMPARATOR | Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). |
| GP2015 Etanercept | EXPERIMENTAL | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
| Enbrel ® Etanercept | ACTIVE_COMPARATOR | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
| Name | Type | Description |
|---|---|---|
| GP2015 | DRUG | Enbrel comparator |
| GP2015 Etanercept | DRUG | Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel. |
| Enbrel | DRUG | Enbrel is used as reference product to GP2015. |
Inclusion Criteria: * Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria \>/= 6 months at the time of baseline visit * Patient must have active disease defined as DAS28-CRP\>/=3.2 * Patients must have CRP level above ULN \>5mg/l) or erythrocyte sed...
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GP2015 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It is currently in Phase 3 clinical development and has completed one trial comparing its efficacy and safety to Enbrel in patients with this condition.
GP2015 is a small molecule, but its specific molecular target has not been disclosed. The drug is being evaluated for its efficacy and safety in rheumatoid arthritis, with a completed Phase 3 trial comparing it to Enbrel.
GP2015 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in rheumatoid arthritis.
GP2015 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, active-controlled study involving 376 participants with rheumatoid arthritis. The drug is not yet approved and remains investigational.
GP2015 has one completed clinical trial, identified as NCT02638259. This Phase 3 study, titled 'Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis,' enrolled 376 participants across multiple countries including the United States, Bulgaria, Czechia, and Germany.
GP2015 is not the same as Enbrel. It is a separate investigational drug being compared to Enbrel in a clinical trial for rheumatoid arthritis. The trial is designed to assess the comparative efficacy and safety of GP2015 against Enbrel, which is an approved treatment.