Osteoarthritis, KneePhase 2NCT03949673
Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip
A Phase 2 study testing Fasinumab, Naproxen and Diclofenac in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Regeneron Pharmaceuticals at 15 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Fasinumab, Naproxen and Diclofenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 8 Apr 2019to 25 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously randomized to R475-PN-1523 (NCT02683239), R475-OA-1611 (NCT03161093), or R475-OA-1688 (NCT03304379) and received at least 1 dose of study drug
- Notified the site that they are planning a knee or hip arthroplasty during the parent study between randomization and 24 weeks after the last dose of subcutaneous (SC) study drug
- Patient's surgeon/pathologist is willing to coordinate with the site regarding preparation, storage, and shipping of joint tissue samples collected during arthroplasty surgery
Who cannot join
- None
- Note: Other protocol Inclusion criteria apply
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United Kingdom8 sites
Regeneron Research Site
Glasgow, Lanarkshire, G20-0SP
Regeneron Research Site
Hexham, Northumberland, NE46 1QJ
Regeneron Research Site
Kenilworth, Warwickshire, CV8 1JD
Regeneron Research Site
Liverpool, L22 0LG
Regeneron Research Site
Northwood, Middlesex, HA6 2RN
Regeneron Research Site
Reading, Berkshire, RG2 0TG
Regeneron Research Site
Romford, London City, RM1 3PJ
Regeneron Research Site
Yaxley, Peterborough, PE7 3JL
United States6 sites
Regeneron Research Site
Brooklyn, New York, 11230
Regeneron Research Site
Chicago, Illinois, 60611
Regeneron Research Site
Jacksonville, Florida, 32256
Regeneron Research Site
Littleton, Colorado, 80127
Regeneron Research Site
New York, New York, 10036
Regeneron Research Site
Phoenix, Arizona, 85020
About this study
Official title: Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
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).
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Fasinumab, Naproxen, Diclofenac, Celecoxib, Placebo
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FasinumabDrug
Also called REGN475
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
NaproxenDrug
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
DiclofenacDrug
Also called ZORVOLEX
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
CelecoxibDrug
Also called CELEBREX
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Fasinumab; Drug: Naproxen; Drug: Diclofenac; Drug: Celecoxib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start8 Apr 2019
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceutical Industries, Ltd.
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949673
- Sponsor's protocol ID
- R475-OA-1816
- Other IDs
- 2018-001618-13, 2018
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2019
- Last updated
- 17 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
- ClinicalTrials.gov ID
- NCT03949673
- Acronym / sponsor ID
- R475-OA-1816
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceutical Industries, Ltd.
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Posted 17 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee or Hip Joint Arthroplasty | Other | Drug: Fasinumab, Drug: Naproxen, Drug: Diclofenac, Drug: Celecoxib, Drug: PlaceboPatients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously randomized to R475-PN-1523 (NCT02683239), R475-OA-1611 (NCT03161093), or R475-OA-1688 (NCT03304379) and received at least 1 dose of study drug
- Notified the site that they are planning a knee or hip arthroplasty during the parent study between randomization and 24 weeks after the last dose of subcutaneous (SC) study drug
- Patient's surgeon/pathologist is willing to coordinate with the site regarding preparation, storage, and shipping of joint tissue samples collected during arthroplasty surgery
Key exclusion criteria (2 listed)
- None
- Note: Other protocol Inclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FasinumabAlso: REGN475Study 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 | Drug | Knee or Hip Joint Arthroplasty |
| NaproxenNaproxen 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 | Drug | Knee or Hip Joint Arthroplasty |
| DiclofenacAlso: ZORVOLEXDiclofenac 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 | Drug | Knee or Hip Joint Arthroplasty |
| CelecoxibAlso: CELEBREXCelecoxib 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 | Drug | Knee or Hip Joint Arthroplasty |
| PlaceboMatching 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 | Drug | Knee or Hip Joint Arthroplasty |
Primary outcome
Number of Participants by Degree of Synovial Lymphocytic Inflammation
Time frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band).
Number of Participants by Degree of Cartilage Loss
Time frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone).
Number of Participants by Degree of Bony Changes
Time frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis [Lamellar/Mixed], Subarticular Fracture/Collapse).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All IPD that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fasinumab, Naproxen and Diclofenac in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Regeneron Pharmaceuticals at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants by Degree of Synovial Lymphocytic Inflammation (time frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.