Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I

NCT01463488 | Completed Phase 1

• 4 other identifiers: TDU116852011-003232-31U1111-1121-3831TDU11685/ACT12505
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives:

• Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.
• Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Pain, Stiffness and Physical Function sub-scales from the WOMAC Index

  during 24 weeks

• Number of patients reporting Adverse Events of special interest: tolerability at the site of injection and in the knee + other events reported by the patient

  during 24 weeks

Secondary Outcomes (4)

• Pharmacokinetics (Cmax)

  during 24 weeks

• Pharmacokinetics (AUC)

  during 24 weeks

• Pharmacokinetics (t1/2)

  during 24 weeks

• synovial fluid levels

  during 24 weeks

Study Arms (4)

SAR113945 - Dose 1

EXPERIMENTAL

Drug: SAR113945

SAR113945 - Dose 2

EXPERIMENTAL

Drug: SAR113945

SAR113945 - Dose 3

EXPERIMENTAL

Drug: SAR113945

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

SAR113945 DRUG

Pharmaceutical form:Injection Route of administration: Intra-articular

SAR113945 - Dose 1; SAR113945 - Dose 2; SAR113945 - Dose 3

placebo DRUG

Pharmaceutical form:Injection Route of administration: Intra-articular

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosis of primary knee osteoarthritis, based upon the following:
• X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
• Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72.
• Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis.

You may not qualify if:

• Patients younger than 40 years
• Women of child bearing potential.
• Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level \>30 IU/L.
• 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, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
• Presence of local skin abnormality at the affected knee joint.
• Intra-articular injection within 3 months.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 276001

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2011
• First Posted: November 2, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

DE (1)