Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02638259 | Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis | PHASE3 | COMPLETED | 376 | — | — | Feb 21, 2015 | Jun 12, 2017 | Sep 19, 2018 | 92 | United States, Bulgaria +14 |
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
| 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). |
| Name | Type | Description |
|---|---|---|
| GP2015 | DRUG | Enbrel comparator |
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...