To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01160822
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — BIOLOGICAL
    Intra-articular injection
  • Placebo to canakinumab — DRUG
    Intra-articular injection
  • Naproxen — DRUG
    Tablets for oral administration
  • Placebo to Naproxen — DRUG
    Tablets for oral administration

Study Details

The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.

Key Dates

Start date
Apr 30, 2010
Status verified
Sep 2012
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
169 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Canakinumab
    In this ascending dose part, participants received a single intra-articular injection of canakinumab. The beginning dose was 150 mg, escalating to the 300 mg dose and then to 600 mg.
  • Placebo Comparator: Part A: Placebo
    Participants received a single intra-articular injection of canakinumab-matching placebo.
  • Experimental: Part B: Canakinumab
    Participants received a single intra-articular injection of canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
  • Placebo Comparator: Part B: Placebo
    Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
  • Active Comparator: Part B: Naproxen
    Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.

Primary Outcome Measure

Part A: Number of Participants With Intolerance Events [ Time Frame: Baseline to Day 3 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LLCAnnistonAlabama36207-
Arizona Arthritis & Rheumatology Research, PLLCMesaArizona85202-
San Diego Arthritis & Osteoporosis Medical ClinicSan DiegoCalifornia92108-
Westlake Medical ResearchWestlake VillageCalifornia91361-
Rush-Presbyterian St. Lukes Medical CenterChicagoIllinois60612-
Cotton O'Neil Clinical Research InstituteTopekaKansas66606-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Volunteer Research GroupKnoxvilleTennessee37920-

Find similar trials in Anniston, AL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Pinnacle Research Group, LLC· Anniston, ALArizona Arthritis & Rheumatology Research, PLLC· Mesa, AZSan Diego Arthritis & Osteoporosis Medical Clinic· San Diego, CAWestlake Medical Research· Westlake Village, CARush-Presbyterian St. Lukes Medical Center· Chicago, ILCotton O'Neil Clinical Research Institute· Topeka, KS

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