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Treatment for Patients With Osteoarthritis (OA)

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ClinicalTrials.gov Identifier: NCT00110942
Recruitment Status : Completed
First Posted : May 17, 2005
Last Update Posted : June 23, 2008
Sponsor:
Information provided by:
Amgen

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Drug: Systemic AMG 108 Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)
Study Start Date : February 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in WOMAC pain score [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Change in WOMAC pain score [ Time Frame: Week 12 ]
  2. Change in WOMAC composite score and function and stiffness index scores [ Time Frame: Weeks 6 and 12 ]
  3. Achieving 50% or more improvement from Day 1 in the WOMAC [ Time Frame: Weeks 6 and 12 ]


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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110942


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
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
First Posted: May 17, 2005    Key Record Dates
Last Update Posted: June 23, 2008
Last Verified: June 2008

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

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