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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01960855 | A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy | PHASE2 | COMPLETED | 276 | — | — | Oct 1, 2013 | Jul 1, 2015 | Aug 24, 2021 | - | — |
| NCT01741493 | A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494 | PHASE1 | COMPLETED | 67 | — | — | Nov 1, 2012 | Dec 1, 2013 | Nov 20, 2017 | 5 | United States |
Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.
Blood pressure, pulse rate and body temperature
Hematology, Chemistry, and Urinalysis
ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration
Cmax, Tmax, AUC, elimination rate constant and half-life
| Arm | Type | Description |
|---|---|---|
| Placebo BID | PLACEBO_COMPARATOR | Placebo twice daily (BID) for 12 weeks. |
| ABT-494 3 mg BID | EXPERIMENTAL | ABT-494 3 mg twice daily (BID) for 12 weeks. |
| ABT-494 6 mg BID | EXPERIMENTAL | ABT-494 6 mg twice daily (BID) for 12 weeks. |
| ABT-494 12 mg BID | EXPERIMENTAL | ABT-494 12 mg twice daily (BID) for 12 weeks. |
| ABT-494 18 mg BID | EXPERIMENTAL | ABT-494 18 mg twice daily (BID) for 12 weeks. |
| Healthy Volunteers (ABT-494) | EXPERIMENTAL | Multiple dosing of ABT-494 in healthy volunteers |
| Rheumatoid Arthritis Patients | EXPERIMENTAL | Multiple dosing of ABT-494 in patients with rheumatoid arthritis |
| No treatment | PLACEBO_COMPARATOR | Placebo administration in healthy volunteers and patients with rheumatoid arthritis |
| Healthy Volunteers (tofa) | OTHER | Multiple dosing of tofacitinib in healthy volunteers |
| Name | Type | Description |
|---|---|---|
| ABT-494 | DRUG | ABT-494 capsule administered orally twice daily (BID). |
| Placebo | DRUG | Placebo for ABT-494 capsule administered orally twice daily (BID). |
| Tofacitinib | DRUG | Oral administration |
Inclusion Criteria: * Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months. * Subjects must have be...