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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01242917 | A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy | PHASE2 | COMPLETED | 159 | — | — | Sep 1, 2010 | Jul 1, 2011 | Mar 6, 2025 | 41 | Belgium, Czechia +6 |
| NCT01027728 | Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid Arthritis | PHASE1 | COMPLETED | 24 | — | — | Dec 1, 2009 | Jul 1, 2010 | Mar 6, 2025 | 5 | Belgium, Romania |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| CCX354-C 100mg twice daily | EXPERIMENTAL | - |
| CCX354-C 200mg once daily | EXPERIMENTAL | - |
| CCX354-C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CCX-354-C | DRUG | 200mg film-coated tablets once daily for 12 weeks + Methotrexate |
| Placebo | DRUG | Placebo film-coated tablets twice daily for 12 weeks + methotrexate |
| CCX354-C | DRUG | 100mg film-coated tablets twice daily for 12 weeks + methotrexate |
| CCX 354-C | DRUG | * Cohort 1: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days; * Cohort 2: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) twice daily for 14 days; and * Cohort 3: Eight subjects will be randomized to receive 200 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days. |
Inclusion Criteria: 1. Male or female subjects, aged 18-75 years inclusive, with functional class I to III rheumatoid arthritis (RA) based on American College of Rheumatology (ACR) criteria for at least 3 months prior to screening; wheel-chair bound subjects or those with irreversible disease will ...