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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01123070 | TL011 in Severe, Active Rheumatoid Arthritis Patients | PHASE1 | COMPLETED | 54 | — | — | Feb 5, 2010 | Apr 23, 2012 | Oct 4, 2021 | 18 | Czechia, Hungary +3 |
| Arm | Type | Description |
|---|---|---|
| TL011 | EXPERIMENTAL | TL011 infusions |
| MabThera | ACTIVE_COMPARATOR | MabThera infusions |
| Name | Type | Description |
|---|---|---|
| TL011, anti CD20, for the treatment of rheumatoid arthritis | BIOLOGICAL | TL011 administered by 2 infusions, 2 weeks apart |
| MabThera infusions | BIOLOGICAL | MabThera, administered by 2 infusions, 2 weeks apart |
Inclusion Criteria: * Adult subjects * Rheumatoid arthritis as defined by the 1987 ACR Classification * Severe active seropositive disease * Inadequate response or intolerance to other DMARDs * Treatment with MTX Exclusion Criteria: * Rheumatic autoimmune disease other than RA * Active infection ...