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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001618-13 | EudraCT Number |
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Lack of enrollment
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| Name | Class |
|---|---|
| Teva Pharmaceutical Industries, Ltd. | INDUSTRY |
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The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with Osteoarthritis (OA) who have been treated with fasinumab, compared with those treated with placebo or Non-steroidal anti-inflammatory drugs (NSAIDs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee or Hip Joint Arthroplasty | Other | Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasinumab | Drug | Study drug will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants by Degree of Synovial Lymphocytic Inflammation | Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band). | Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months |
| Number of Participants by Degree of Cartilage Loss | Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone). | Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months |
| Number of Participants by Degree of Bony Changes | Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis [Lamellar/Mixed], Subarticular Fracture/Collapse). | Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months |
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Key Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol Inclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Site | Phoenix | Arizona | 85020 | United States | ||
| Regeneron Research Site |
All IPD that underlie publicly available results will be considered for sharing.
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Non-steroidal Anti-inflammatory Drug (NSAID) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2018 | Aug 15, 2023 |
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|
| Naproxen | Drug | Naproxen will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study |
|
| Diclofenac | Drug | Diclofenac will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study |
|
|
| Celecoxib | Drug | Celecoxib will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study |
|
|
| Placebo | Drug | Matching Placebo will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study |
|
| Littleton |
| Colorado |
| 80127 |
| United States |
| Regeneron Research Site | Jacksonville | Florida | 32256 | United States |
| Regeneron Research Site | Chicago | Illinois | 60611 | United States |
| Regeneron Research Site | Brooklyn | New York | 11230 | United States |
| Regeneron Research Site | New York | New York | 10036 | United States |
| Regeneron Recruting SIte | Bialystok | 15-879 | Poland |
| Regeneron Research Site | Reading | Berkshire | RG2 0TG | United Kingdom |
| Regeneron Research Site | Glasgow | Lanarkshire | G20-0SP | United Kingdom |
| Regeneron Research Site | Romford | London City | RM1 3PJ | United Kingdom |
| Regeneron Research Site | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Regeneron Research Site | Hexham | Northumberland | NE46 1QJ | United Kingdom |
| Regeneron Research Site | Yaxley | Peterborough | PE7 3JL | United Kingdom |
| Regeneron Research Site | Kenilworth | Warwickshire | CV8 1JD | United Kingdom |
| Regeneron Research Site | Liverpool | L22 0LG | United Kingdom |
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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
|
Arthroplasty analysis set: All subjects who are enrolled in this study, have histological evaluation data and is based on the treatment received in their parent study (as treated).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants by Degree of Synovial Lymphocytic Inflammation | Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band). | 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). | Posted | Count of Participants | Participants | Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants by Degree of Cartilage Loss | Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone). | 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). | Posted | Count of Participants | Participants | Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants by Degree of Bony Changes | Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis [Lamellar/Mixed], Subarticular Fracture/Collapse). | 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). | Posted | Count of Participants | Participants | Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months |
|
Safety was not analyzed or collected specifically for this sub-study
Participants followed screening and pre-randomization requirements of their parent study and if they decided to undergo a joint replacement during the parent study, they could consent to this substudy. Safety data were collected during the parent studies.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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The study was anticipated to close in Feb 2021, but ended prematurely on 25 Aug 2020 (date of global last arthroplasty surgery for last subject enrolled) due to lack of enrollment.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2020 | Aug 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000626997 | fasinumab |
| D009288 | Naproxen |
| D004008 | Diclofenac |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Marked/Band |
|
|
|
|
|