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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02514772 | GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® | PHASE3 | COMPLETED | 107 | — | — | Jul 1, 2015 | Oct 1, 2016 | Dec 28, 2017 | 65 | United States, Germany +2 |
2006 NIAID/FAAN\* criteria were used for identification of anaphylactic reactions within 24h of each study drug infusion. For patients with no history of infusion-related reactions during their previous treatments with rituximab, symptoms/signs in at least 2 out of 4 organ systems: * Skin/mucosal tissue * Respiratory organs * Drop of systolic blood pressure (\<90 mmHg or variance from baseline \>30%) or associated symptoms * Gastrointestinal organs were defined as an anaphylactic reaction. The same criteria were also applied to patients with history of infusion-related reactions during their previous treatments with rituximab. In addition, if these patients experienced only a rapid drop in systolic blood pressure (\<90 mmHg or variance from baseline \>30%), this was defined as an anaphylactic reaction disregarding involvement of other organ systems. \* NIAID - National Institute of Allergy and Infectious Diseases FAAN - Food Allergy and Anaphylaxis Network
The standardized MedDRA query (SMQ) - Hypersensitivity reactions (SMQ 20000214) was used for the identification of hypersensitivity reactions overall from first infusion in the adverse event database.
Number of patients tested positive for anti-drug-antibodies (ADA) post-randomization. Patients with negative ADA results at screening and at least one evaluable post-randomization ADA assessment are included in the analysis
Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.
| Arm | Type | Description |
|---|---|---|
| GP2013 - proposed biosimilar rituximab | EXPERIMENTAL | 10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14). |
| Originator rituximab - Rituxan ® or MabThera ® | ACTIVE_COMPARATOR | 10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14). |
| Name | Type | Description |
|---|---|---|
| GP2013 - A Proposed biosimilar rituximab | BIOLOGICAL | - |
| Originator rituximab - Rituxan ® or MabThera ® | BIOLOGICAL | - |
Inclusion Criteria: * Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria * Completed one full treatment course with either Rituxan® or MabThera® * Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated with methotrexate Exclusion Criteria: * RA fu...