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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02336698 | Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3002 | PHASE3 | COMPLETED | 18 | — | — | Jul 13, 2015 | Sep 15, 2016 | Oct 2, 2017 | 32 | United States, Poland +2 |
| NCT02289716 | Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003 | PHASE3 | COMPLETED | 41 | — | — | Jul 10, 2015 | Oct 10, 2016 | Apr 29, 2025 | 28 | United States, Belgium +6 |
| NCT02336685 | Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001 | PHASE3 | COMPLETED | 79 | — | — | Jul 7, 2015 | Sep 16, 2016 | Oct 2, 2017 | 53 | United States, Canada +4 |
| NCT02301234 | Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007 | PHASE3 | COMPLETED | 111 | — | — | Mar 25, 2015 | Sep 19, 2016 | Sep 14, 2017 | 64 | United States, Australia +9 |
The WOMAC 3.1 is a multi-dimensional, osteoarthritis (OA) specific self-administered questionnaire using 24 questions with a 48-hour recall that are grouped into 3 subscales (pain, stiffness, and physical function) associated with hip or knee OA. Pain, stiffness, and physical function is rated on a scale of 0-10 (0 = less severe up to 10 = more severe).
See WOMAC 3.1 described above.
The PGA is part of a comprehensive assessment of the impact of treatment for osteoarthritis that also includes pain and physical function. The PGA included in the present study indicates the perception of osteoarthritis in the study joint at the current time. Ratings are provided on an 11-point numerical rating scale from 0 ("Very Good") to 10 ("Very Bad").
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks). |
| Fulranumab 1 mg | EXPERIMENTAL | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks). |
| Fulranumab 3 mg | EXPERIMENTAL | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen. |
| Fulranumab 1 mg | DRUG | Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen. |
| Fulranumab 3 mg | DRUG | Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen. |
| Opioid | DRUG | Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion. |
| Celecoxib 100 mg | DRUG | Double-blind capsules taken twice daily for up to 16 weeks. |
| Celecoxib 100 mg Matching Placebo | DRUG | Double-blind capsules taken twice daily for up to 16 weeks. |
Inclusion Criteria: * Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class ≥2) of the study joint * Scheduled joint replacement or planning to undergo a joint replacement s...