- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00110942
Treatment for Patients With Osteoarthritis (OA)
June 20, 2008 updated by: Amgen
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Minor sub-study AMG 108
N = 15
|
300 mg SC AMG 108 Q4W for 3 doses
|
Placebo Comparator: Minor sub-study placebo
N = 15
|
SC placebo injection Q4W for 3 doses
|
Active Comparator: Main sub-study AMG 108
N = 73
|
300 mg SC AMG 108 Q4W for 3 doses
|
Placebo Comparator: Main sub-study placebo
N = 73
|
SC placebo injection Q4W for 3 doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in WOMAC pain score
Time Frame: Week 6
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in WOMAC pain score
Time Frame: Week 12
|
Week 12
|
Change in WOMAC composite score and function and stiffness index scores
Time Frame: Weeks 6 and 12
|
Weeks 6 and 12
|
Achieving 50% or more improvement from Day 1 in the WOMAC
Time Frame: Weeks 6 and 12
|
Weeks 6 and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
May 16, 2005
First Submitted That Met QC Criteria
May 16, 2005
First Posted (Estimate)
May 17, 2005
Study Record Updates
Last Update Posted (Estimate)
June 23, 2008
Last Update Submitted That Met QC Criteria
June 20, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20040166
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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