OsteoarthritisPhase 1NCT01113333
Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis
A Phase 1 study testing SAR113945 in people with Osteoarthritis, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis. Secondary Objective: Assess systemic exposure of SAR113945 following intra-articular delivery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- 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
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Feb 2011
- 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
- Male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having:
- X-ray or Magnetic Resonance Imaging (MRI) evidence for Kellgren Lawrence Grades II./III joint space narrowing and osteophyte formation,
- Western Ontario MacMaster (WOMAC) score ≦ 72,
- American College of Rheumatology (ACR) Clinical and Radiographic criteria for osteoarthritis.
Who cannot join
- Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Principal Investigator, could potentially put the patient at increased risk.
- Secondary osteoarthritis.
- Moderate/severe renal impairment.
- Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) > 3 Upper Limit of Normal range.
- Intra-articular injection within 3 months.
- Presence of local skin abnormality at the affected knee joint.
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- Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol or metamizole as analgesic.
- Any Investigational Product within 3 months.
- Any patient unlikely to comply with the requirements of the study.
- 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 Double Blind, Placebo Controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the IKK Inhibitor, SAR113945, Following Intra-articular Administration in Patients With Knee Osteoarthritis
Primary Objective:
- Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.
Secondary Objective:
- Assess systemic exposure of SAR113945 following intra-articular delivery.
Read the detailed description
The total study duration per subject ranges from 4 to 20 weeks broken down as follows:
- screening within 4 weeks before dosing,
- follow-up of 4 weeks (28 days) after the single dose of study medication,
- prolonged by a maximum of 12 weeks if plasma PK level > Limit Of Quantification (LOQ) at Day 28.
- Conditions
- Osteoarthritis
- Being tested
- placebo, SAR113945
- Medical subject headings
- Osteoarthritis
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 |
|---|---|---|
| SAR113945 | Experimental | SAR113945, single dose according to dose escalation design Receives: Drug: SAR113945 |
| Placebo | Placebo comparator | 0.9% saline solution, single dose Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))
Measured: 4 weeks up to a maximum of 12 weeks
Examination of skin/soft tissue of injected knee
Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.
Measured: 4 weeks up to a maximum of 12 weeks
Examination of knee joint of injected knee
Any reaction is classified as effusion/worsening of effusion, warm and pain.
Measured: 4 weeks up to a maximum of 12 weeks
Secondary outcomes (2)
Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2)
Measured: 4 weeks up to a maximum of 16 weeks
Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113333
- Sponsor's protocol ID
- TDU10820
- Other IDs
- 2009-017502-36, U1111-1116-5630, 2009
- Status last verified
- Mar 2011
- First submitted
- 23 Apr 2010
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the IKK Inhibitor, SAR113945, Following Intra-articular Administration in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01113333
- Acronym / sponsor ID
- TDU10820
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Apr 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.
Primary Objective:
- Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.
Secondary Objective:
- Assess systemic exposure of SAR113945 following intra-articular delivery.
Detailed description
The total study duration per subject ranges from 4 to 20 weeks broken down as follows:
- screening within 4 weeks before dosing,
- follow-up of 4 weeks (28 days) after the single dose of study medication,
- prolonged by a maximum of 12 weeks if plasma PK level > Limit Of Quantification (LOQ) at Day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR113945 | Experimental | Drug: SAR113945SAR113945, single dose according to dose escalation design |
| Placebo | Placebo comparator | Drug: placebo0.9% saline solution, single dose |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having:
Key exclusion criteria (10 listed)
- Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Principal Investigator, could potentially put the patient at increased risk.
- Secondary osteoarthritis.
- Moderate/severe renal impairment.
- Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) > 3 Upper Limit of Normal range.
- Intra-articular injection within 3 months.
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 | SAR113945 |
Primary outcome
Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))
Time frame: 4 weeks up to a maximum of 12 weeks
Examination of skin/soft tissue of injected knee
Time frame: 4 weeks up to a maximum of 12 weeks
Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.
Examination of knee joint of injected knee
Time frame: 4 weeks up to a maximum of 12 weeks
Any reaction is classified as effusion/worsening of effusion, warm and pain.
2 secondary outcomes
Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2)
Time frame: 4 weeks up to a maximum of 16 weeks
Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover)
Time frame: 4 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 23 Mar 2011.
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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 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 Osteoarthritis, run by Sanofi at 1 site in Germany.
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 4 inclusion and 10 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 23 Mar 2011. 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 Germany. 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?
Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis)) (time frame: 4 weeks up to a maximum of 12 weeks). 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 23 Mar 2011.