OsteoarthritisPhase 2NCT01239017
A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
A Phase 2 study testing REGN475 in people with Osteoarthritis, run by Regeneron Pharmaceuticals.
Trial summary
This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo). Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- REGN475
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
- Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.
Who cannot join
- Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
- Patients with joint replacement in the affected knee.
- Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit.
- Women who are pregnant or breast-feeding.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Single Dose Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo).
Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive placebo SC.
- Conditions
- Osteoarthritis
- Being tested
- REGN475, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN475Biological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | SC REGN475 Dose 1 and IV Placebo Receives: Biological: REGN475 |
| Dose 2 | Experimental | SC REGN475 Dose 2 and IV Placebo Receives: Biological: REGN475 |
| Dose 3 | Experimental | SC REGN475 Dose 3 and IV Placebo Receives: Biological: REGN475 |
| Dose 4 | Experimental | SC Placebo and IV REGN475 Dose 4 Receives: Biological: REGN475 |
| Dose 5 | Placebo comparator | SC Placebo and IV Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
Measured: 16 weeks
Secondary outcomes (6)
Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
Measured: 8 weeks
Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
Measured: 8 weeks
Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Measured: 8 weeks
Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Measured: 8 weeks
Patient assessment of response to treatment over time using the Patient Global Impression of Change.
Measured: 16 weeks
Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Investigators
- Paul J Tiseo, PhD, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239017
- Sponsor's protocol ID
- R475-PN-1004
- Status last verified
- Mar 2015
- First submitted
- 9 Nov 2010
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Single Dose Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01239017
- Acronym / sponsor ID
- R475-PN-1004
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo).
Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive placebo SC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Biological: REGN475SC REGN475 Dose 1 and IV Placebo |
| Dose 2 | Experimental | Biological: REGN475SC REGN475 Dose 2 and IV Placebo |
| Dose 3 | Experimental | Biological: REGN475SC REGN475 Dose 3 and IV Placebo |
| Dose 4 | Experimental | Biological: REGN475SC Placebo and IV REGN475 Dose 4 |
| Dose 5 | Placebo comparator | Other: PlaceboSC Placebo and IV Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
- Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.
Key exclusion criteria (4 listed)
- Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
- Patients with joint replacement in the affected knee.
- Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit.
- Women who are pregnant or breast-feeding.
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 |
|---|---|---|
| REGN475 | Biological | Dose 1, Dose 2, Dose 3, Dose 4 |
| Placebo | Other | Dose 5 |
Primary outcome
The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
Time frame: 16 weeks
6 secondary outcomes
Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
Time frame: 8 weeks
Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
Time frame: 8 weeks
Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time frame: 8 weeks
Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time frame: 8 weeks
Patient assessment of response to treatment over time using the Patient Global Impression of Change.
Time frame: 16 weeks
Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Paul J Tiseo, PhD study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REGN475 in people with Osteoarthritis, run by Regeneron Pharmaceuticals.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo. (time frame: 16 weeks). 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 18 Mar 2015.