Trial Outcomes & Findings for Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip (NCT NCT03949673)
NCT ID: NCT03949673
Last Updated: 2023-10-17
Results Overview
Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Results posted on
2023-10-17
Participant Flow
This study only included participants that received at least 1 dose of study drug in one of the 3 parent studies: R475-PN-1523 (NCT02683239), R475-OA-1611 (NCT03161093), or R475-OA-1688 (NCT03304379).
Participant milestones
| Measure |
Placebo
Placebo was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Non-steroidal Anti-inflammatory Drug (NSAID)
Non-steroidal anti-inflammatory drugs (NSAID) were administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Fasinumab
Fasinumab was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
13
|
|
Overall Study
COMPLETED
|
2
|
5
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
Placebo was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Non-steroidal Anti-inflammatory Drug (NSAID)
n=5 Participants
Non-steroidal anti-inflammatory drugs (NSAID) were administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Fasinumab
n=13 Participants
Fasinumab was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 7.8 • n=93 Participants
|
60.2 Years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
67.3 Years
STANDARD_DEVIATION 8.2 • n=27 Participants
|
64.9 Years
STANDARD_DEVIATION 8.4 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 monthsPopulation: Arthroplasty analysis set: All participants who are enrolled in this study, have histological evaluation data and is based on the treatment received in their parent study (as treated).
Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band).
Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Non-steroidal Anti-inflammatory Drug (NSAID)
n=5 Participants
Non-steroidal anti-inflammatory drugs (NSAID) were administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Fasinumab
n=13 Participants
Fasinumab was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
|---|---|---|---|
|
Number of Participants by Degree of Synovial Lymphocytic Inflammation
None present
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants by Degree of Synovial Lymphocytic Inflammation
Slight/Mild
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants by Degree of Synovial Lymphocytic Inflammation
Moderate
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants by Degree of Synovial Lymphocytic Inflammation
Marked/Band
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 monthsPopulation: Arthroplasty analysis set: All participants who are enrolled in this study, have histological evaluation data and is based on the treatment received in their parent study (as treated).
Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone).
Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Non-steroidal Anti-inflammatory Drug (NSAID)
n=5 Participants
Non-steroidal anti-inflammatory drugs (NSAID) were administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Fasinumab
n=13 Participants
Fasinumab was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
|---|---|---|---|
|
Number of Participants by Degree of Cartilage Loss
Deep fissuring
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Degree of Cartilage Loss
Loss to Tide Mark
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Degree of Cartilage Loss
Superficial Fibrillation
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by Degree of Cartilage Loss
Loss to Exposed Bone
|
1 Participants
|
3 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 monthsPopulation: Arthroplasty analysis set: All participants who are enrolled in this study, have histological evaluation data and is based on the treatment received in their parent study (as treated).
Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis \[Lamellar/Mixed\], Subarticular Fracture/Collapse).
Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Non-steroidal Anti-inflammatory Drug (NSAID)
n=5 Participants
Non-steroidal anti-inflammatory drugs (NSAID) were administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
Fasinumab
n=13 Participants
Fasinumab was administered in the parent studies; joint tissue samples for this study were collected for participants who voluntarily elected to have knee or hip joint arthroplasty during the parent studies
|
|---|---|---|---|
|
Number of Participants by Degree of Bony Changes
Normal
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by Degree of Bony Changes
Sclerosis (Lamellar/Mixed)
|
1 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants by Degree of Bony Changes
Subarticular Fracture/Collapse
|
0 Participants
|
2 Participants
|
5 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-steroidal Anti-inflammatory Drug (NSAID)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fasinumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER