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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00883896 | Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis | PHASE2 | COMPLETED | 195 | — | — | Jun 18, 2009 | Feb 18, 2011 | Oct 21, 2022 | 52 | United States, Belgium +9 |
ACR20 response: greater than or equal to (\>=) 20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
| Arm | Type | Description |
|---|---|---|
| Arm 1 | PLACEBO_COMPARATOR | Part 1: Placebo |
| Arm 2 | EXPERIMENTAL | Part 1: 100 mg ILV-094 SC Q4W |
| Arm 3 | EXPERIMENTAL | Part 1: 100 mg ILV-094 SC Q2W |
| Arm 4 | PLACEBO_COMPARATOR | - |
| Arm 5 | EXPERIMENTAL | Part 2: 200 mg ILV-094 SC Q2W |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Part 1: Placebo SC administration every 2 weeks X 10 weeks. |
| ILV-094 | DRUG | Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks. |
Inclusion Criteria: * Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening * Active RA at the time of screening and baseline consisting of \>= 5 swollen and \>= 5 tender joints (28-joint count...