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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04268771 | A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products | PHASE3 | COMPLETED | 140 | — | — | Apr 8, 2020 | Apr 20, 2022 | Nov 18, 2023 | 26 | United States |
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 15 was reported
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 4 was reported
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 8 was reported
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 12 visits was reported
| Arm | Type | Description |
|---|---|---|
| Arm A: DRL_RI | EXPERIMENTAL | Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15 |
| Arm B: US-Rituximab or EU-Rituximab | ACTIVE_COMPARATOR | Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled. Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively. |
| Name | Type | Description |
|---|---|---|
| Experimental: Arm A: DRL_RI | BIOLOGICAL | Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion |
| Arm B: Rituxan®/Mabthera® | BIOLOGICAL | Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion |
Inclusion Criteria: 1. Male or female subjects aged 18 years or older who have provided valid written informed consent. 2. Subjects with a diagnosis of active RA who are eligible for the subsequent treatment course with US-rituximab or EU-rituximab according to the clinical judgment of the investig...