Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01113333
First received: April 23, 2010
Last updated: March 22, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: placebo Drug: SAR113945 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Examination of skin/soft tissue of injected knee [ Time Frame: 4 weeks up to a maximum of 12 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Any reaction is classified as effusion/worsening of effusion, warm and pain.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2010 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SAR113945
SAR113945, single dose according to dose escalation design
|
Drug: SAR113945
Pharmaceutical form:injection Route of administration: intra-articular |
|
Placebo Comparator: Placebo
0.9% saline solution, single dose
|
Drug: placebo
Pharmaceutical form:injection Route of administration: intra-articular |
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
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.
Exclusion criteria:
- 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.
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Trial Transparency Team, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT01113333 History of Changes |
| Other Study ID Numbers: | TDU10820, 2009-017502-36, U1111-1116-5630 |
| Study First Received: | April 23, 2010 |
| Last Updated: | March 22, 2011 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013