NCT01511549

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 1, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

January 6, 2012

Last Update Submit

September 28, 2012

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)

    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.

    up to 24 weeks

Secondary Outcomes (6)

  • Pharmacokinetic parameter (AUC)

    21 time points up to 24 weeks

  • Pharmacokinetic parameter (Cmax)

    21 time points up to 24 weeks

  • Pharmacokinetic parameter (tmax)

    21 time points up to 24 weeks

  • Pharmacokinetic parameter (t1/2)

    21 time points up to 24 weeks

  • Pharmacodynamic parameter (WOMAC index)

    up to 24 weeks

  • +1 more secondary outcomes

Study Arms (4)

Dose 1

EXPERIMENTAL

SAR113945 low dose

Drug: SAR113945

Dose 2

EXPERIMENTAL

SAR113945 medium dose

Drug: SAR113945

Dose 3

EXPERIMENTAL

SAR113945 high dose

Drug: SAR113945

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

placeboDRUG

Pharmaceutical form:injection Route of administration: intra-articular

Placebo
SAR113945DRUG

Pharmaceutical form:injection Route of administration: intra-articular

Dose 1Dose 2Dose 3

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site Number 392001

Osaka, 532-0003, Japan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic 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

January 6, 2012

First Posted

January 18, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 1, 2012

Record last verified: 2012-09

Locations

JP(1)