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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02792699 | Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab | PHASE3 | COMPLETED | 311 | — | — | May 17, 2016 | Oct 8, 2018 | Oct 6, 2020 | 55 | United States, Bulgaria +4 |
Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUCinf was estimated using the linear trapezoidal rule.
Maximum observed concentration following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
| Arm | Type | Description |
|---|---|---|
| ABP 798 / ABP 798 | EXPERIMENTAL | Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart. |
| Rituximab (US) / ABP 798 | ACTIVE_COMPARATOR | Participants received rituximab (United States \[US\] formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart. |
| Rituximab (EU) / Rituximab (EU) | ACTIVE_COMPARATOR | Participants received rituximab (European Union \[EU\] formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart. |
| Name | Type | Description |
|---|---|---|
| ABP 798 | DRUG | Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration. |
| Rituximab (US) | DRUG | Supplied as a 10 mg/mL liquid concentrate for IV administration. |
| Rituximab (EU) | DRUG | Supplied as a 10 mg/mL liquid concentrate for IV administration. |
Inclusion Criteria: * Men or women ≥ 18 and ≤ 80 years old * Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before baseline * Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening: * eryt...