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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04577781 | A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate | PHASE2 | COMPLETED | 28 | — | — | Oct 12, 2020 | Apr 7, 2021 | Jul 18, 2022 | 9 | Bulgaria, Georgia +2 |
The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as TJC28, SJC28, patient's global assessment of disease activity, and serum CRP level. * TJC28 ranges from 0-28 * SJC28 ranges from 0-28 * High sensitivity C-reactive protein (hsCRP) (in mg/L) * Patient's disease activity VAS (in mm) (ranges from 0 = best to 100 = worst) The DAS28 (CRP) score was calculated using the below formula: DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln\[1+CRP(in mg/L)\] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity.
| Arm | Type | Description |
|---|---|---|
| GLPG3970 | EXPERIMENTAL | Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
| Name | Type | Description |
|---|---|---|
| GLPG3970 | DRUG | GLPG3970 powder and solvent for oral solution to be reconstituted prior to use. |
| Placebo | DRUG | Placebo powder and solvent for oral solution to be reconstituted prior to use. |
Key Inclusion Criteria: 1. A body mass index (BMI) between 18-32 kg/m\^2, inclusive. 2. Diagnosis of RA ≥6 months prior to screening AND meeting the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria of RA AND ACR functional class I-III. 3. Have ≥6 swol...