Treatment for Patients With Osteoarthritis (OA)
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00110942
First received: May 16, 2005
Last updated: June 20, 2008
Last verified: June 2008
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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 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 May 16, 2013