Phase 2
Completed N=281
Open-label Extension Study Of RN624
Osteoarthritis · OA Knee Pain · Arthritis
Source: ClinicalTrials.gov NCT00399490 ↗
Enrolled (actual)
281
Serious AEs
2.9%
Results posted
Feb 2021
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 168; 8 Participants
Summary
Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
168; 8 | — |
| SECONDARY Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
67.4; 67.4; -25.3; -16.6; -38.0; -39.1 | — |
| SECONDARY Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
71.9; 71.6; -25.0; -17.4; -40.8; -42.2 | — |
| SECONDARY Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
66.7; 67.6; -24.3; -15.9; -37.9; -40.2 | — |
| SECONDARY Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
69.8; 68.5; -22.0; -13.0; -36.5; -39.6 | — |
| SECONDARY Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
53.3; 50.5; 10.4; 8.4; 20.3; 25.9 | — |
| SECONDARY Number of Participants With Response to Participant Satisfaction Questionnaire |
191; 36; 14; 26; 189; 57 | — |
| SECONDARY Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
75.9; 45.4; 63.3; 50.4; 63.2; 83.9 | — |
| SECONDARY Percentage of Participants Who Discontinued the Study |
34.9 | — |
| SECONDARY Median Time in Study A4091009 |
198 | — |
Eligibility Criteria
Inclusion Criteria
- Enrolled in Study RN624-CL006
Exclusion Criteria
- The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension
- Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study
Data sourced from ClinicalTrials.gov (NCT00399490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.