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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00664716 | Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants | PHASE2 | COMPLETED | 391 | — | — | Jul 1, 2007 | Oct 1, 2008 | Jan 21, 2016 | 8 | Argentina, Brazil +6 |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | subcutaneous administration of placebo given for 12 weeks |
| One Dose | EXPERIMENTAL | BG9924 - dosage level administered as per Biogen Idec protocol |
| Second Dose | EXPERIMENTAL | BG9924 - dosage level administered as per Biogen Idec protocol |
| Third Dose | EXPERIMENTAL | BG9924 - dosage level administered as per Biogen Idec protocol |
| Fourth Dose | EXPERIMENTAL | BG9924 - dosage level administered as per Biogen Idec protocol |
| Fifth Dose | EXPERIMENTAL | BG9924 - dosage level administered as per Biogen Idec protocol |
| Name | Type | Description |
|---|---|---|
| Baminercept alfa 1 | BIOLOGICAL | experimental - one dose level |
| Placebo | BIOLOGICAL | Placebo comparator |
| Baminercept alfa 2 | BIOLOGICAL | experimental - second dose level |
| Baminercept alfa 3 | BIOLOGICAL | experimental - third dose level |
| Baminercept alfa 4 | BIOLOGICAL | experimental - fourth dose level |
| Baminercept alfa 5 | BIOLOGICAL | experimental - fifth dose level |
Key Inclusion Criteria: * Diagnosis of RA (functional class I - III) * Stable dose of MTX * Inadequate response to at least one conventional DMARD therapy Key Exclusion Criteria: * Serious local infection or systemic infection * History (Hx) of recurrent infections requiring oral or parenteral an...