Knee OsteoarthritisPhase 1NCT01511549
Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis
A Phase 1 study testing SAR113945 in people with Knee Osteoarthritis, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses Secondary Objective: To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- SAR113945
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese male or female patients, aged 40 years or older, with knee osteoarthritis
- Diagnosis of primary knee osteoarthritis, based upon the following:
- X-ray or magnetic response imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
- Patients will be Kellegen and Lawrence classification II or III, and total Western Ontario McMaster (WOMAC) score below or equal to 72
- Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis
Who cannot join
- Women of child bearing potential
- Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos syndrome, Gaucher's disease, Stickler's syndrome, joint infection, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy
- Presence of local skin abnormality at the affected knee joint
- Any patient who received intra-articular injection within 3 months prior to administration
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis
Primary Objective:
To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses
Secondary Objective:
To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses
Read the detailed description
Following the single dose of study medication, the study period for each patient will be 168 days.
- Conditions
- Knee Osteoarthritis
- Being tested
- placebo, SAR113945
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Pharmaceutical form:injection
Route of administration: intra-articular
SAR113945Drug
Pharmaceutical form:injection
Route of administration: intra-articular
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | SAR113945 low dose Receives: Drug: SAR113945 |
| Dose 2 | Experimental | SAR113945 medium dose Receives: Drug: SAR113945 |
| Dose 3 | Experimental | SAR113945 high dose Receives: Drug: SAR113945 |
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
Measured: up to 24 weeks
Examination of skin/soft tissue of injected knee, and knee joint
Examination of skin/soft tissue of injected knee: Any reaction is classified as erythema, edema, pain, hematoma and graded none, mild, moderate or severe.
Examination of knee joint of injected knee: Any reaction is classified as effusion/worsening of effusion, warmth and pain.
Measured: up to 24 weeks
Secondary outcomes (6)
Pharmacokinetic parameter (AUC)
Measured: 21 time points up to 24 weeks
Pharmacokinetic parameter (Cmax)
Measured: 21 time points up to 24 weeks
Pharmacokinetic parameter (tmax)
Measured: 21 time points up to 24 weeks
Pharmacokinetic parameter (t1/2)
Measured: 21 time points up to 24 weeks
Pharmacodynamic parameter (WOMAC index)
Measured: up to 24 weeks
Pharmacodynamic parameter (biomarkers relating to osteoarthritis)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511549
- Sponsor's protocol ID
- TDU11333
- Other IDs
- U1111-1121-4499
- Status last verified
- Sep 2012
- First submitted
- 6 Jan 2012
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01511549
- Acronym / sponsor ID
- TDU11333
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Jan 2012 (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.
Primary Objective:
To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses
Secondary Objective:
To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses
Detailed description
Following the single dose of study medication, the study period for each patient will be 168 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: SAR113945SAR113945 low dose |
| Dose 2 | Experimental | Drug: SAR113945SAR113945 medium dose |
| Dose 3 | Experimental | Drug: SAR113945SAR113945 high dose |
| Placebo | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Japanese male or female patients, aged 40 years or older, with knee osteoarthritis
- Diagnosis of primary knee osteoarthritis, based upon the following:
Key exclusion criteria (5 listed)
- Women of child bearing potential
- Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos syndrome, Gaucher's disease, Stickler's syndrome, joint infection, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy
- Presence of local skin abnormality at the affected knee joint
- Any patient who received intra-articular injection within 3 months prior to administration
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| placeboPharmaceutical form:injection Route of administration: intra-articular | Drug | Placebo |
| SAR113945Pharmaceutical form:injection Route of administration: intra-articular | Drug | Dose 1, Dose 2, Dose 3 |
Primary outcome
Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
Time frame: up to 24 weeks
Examination of skin/soft tissue of injected knee, and knee joint
Time frame: up to 24 weeks
Examination of skin/soft tissue of injected knee: Any reaction is classified as erythema, edema, pain, hematoma and graded none, mild, moderate or severe. Examination of knee joint of injected knee: Any reaction is classified as effusion/worsening of effusion, warmth and pain.
6 secondary outcomes
Pharmacokinetic parameter (AUC)
Time frame: 21 time points up to 24 weeks
Pharmacokinetic parameter (Cmax)
Time frame: 21 time points up to 24 weeks
Pharmacokinetic parameter (tmax)
Time frame: 21 time points up to 24 weeks
Pharmacokinetic parameter (t1/2)
Time frame: 21 time points up to 24 weeks
Pharmacodynamic parameter (WOMAC index)
Time frame: up to 24 weeks
Pharmacodynamic parameter (biomarkers relating to osteoarthritis)
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
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
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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 Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR113945 in people with Knee Osteoarthritis, run by Sanofi at 1 site in Japan.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests) (time frame: up to 24 weeks). The study lists 2 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 1 Oct 2012.