Treatment for Patients With Osteoarthritis (OA)

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00110942
First received: May 16, 2005
Last updated: June 20, 2008
Last verified: June 2008
  Purpose

The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain score) of AMG 108 (300 mg subcutaneously [SC] every 4 weeks) in subjects with OA.


Condition Intervention Phase
Osteoarthritis
Drug: Systemic AMG 108
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Systemic AMG 108 in Subjects With Osteoarthritis (OA)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change in WOMAC pain score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in WOMAC pain score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change in WOMAC composite score and function and stiffness index scores [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]
  • Achieving 50% or more improvement from Day 1 in the WOMAC [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: February 2005
Study Completion Date: November 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Minor sub-study AMG 108
N = 15
Drug: Systemic AMG 108
300 mg SC AMG 108 Q4W for 3 doses
Placebo Comparator: Minor sub-study placebo
N = 15
Other: Placebo
SC placebo injection Q4W for 3 doses
Active Comparator: Main sub-study AMG 108
N = 73
Drug: Systemic AMG 108
300 mg SC AMG 108 Q4W for 3 doses
Placebo Comparator: Main sub-study placebo
N = 73
Other: Placebo
SC placebo injection Q4W for 3 doses

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria
  • Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
  • If currently taking any over the counter nutritional supplements, must be on stable doses for greater than 2 months prior to screening
  • If utilizing physical therapy, biomechanical devices or orthotic support, must have been using treatment or device for greater than or equal to 2 months prior to screening
  • If currently or previously taking any non-prescribed supplement (e.g., glucosamine or chondroitin sulphate, shark cartilage, diacerein, soya extract, etc.) must be on stable doses for at least 2 months prior to screening
  • If currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), must be on stable doses for at least 2 months prior to screening
  • Able to discontinue NSAIDs at least 5 half-lives (approximately 3 days) prior to Day 1
  • Radiographic evidence of tibio-femoral compartment knee OA within 12 months of screening
  • Signed written informed consent

Exclusion Criteria:

  • Malignancy within the previous 5 years, except for basal cell or in situ cancer
  • Significant hematologic disease - Active infection or history of recurrent or chronic infections
  • Known diagnosis of HIV, hepatitis B, or hepatitis C infection
  • Uncontrolled diabetes or cardiovascular disease and hypertension
  • Inflammatory arthropathy including secondary OA
  • Isolated OA of the patellofemoral joint (bi or tri-compartmental involvement are not exclusions)
  • End-stage ("bone-on-bone") OA (Kellgren Lawrence score of 4)
  • OA of the hip ipsilateral to the index knee - Total white cell count less than 2.0 x 10^9/L and/or platelet count less than 100 x 10^9/L observed within 1 month preceding screening
  • Prior intra-articular (IA) injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent treatment with SC anakinra
  • Concurrent or recent (less than or equal to 1 month) use of experimental therapy
  • Prior IA corticosteroid injection within 1 month of study
  • Prior viscosupplement therapy within 3 months of study
  • Contraindication(s) to IA injections
  • Subjects who are pregnant or breast-feeding, or plan to become pregnant during the study
  • Subject is not using adequate contraception
  • Known allergy to E coli-derived products
  • Unable to understand informed consent
  • Concerns regarding subject's compliance with the protocol procedures
  • Subject will not be available for follow-up assessment
  • Active substance abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110942

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00110942     History of Changes
Other Study ID Numbers: 20040166
Study First Received: May 16, 2005
Last Updated: June 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Intra-articular
Osteoarthritis
OA
anakinra
Amgen

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014