Treatment for Patients With Osteoarthritis (OA) - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00110942

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 II

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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)

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
Minor sub-study AMG 108: Active Comparator N = 15	Drug: Systemic AMG 108 300 mg SC AMG 108 Q4W for 3 doses
Minor sub-study placebo: Placebo Comparator N = 15	Other: Placebo SC placebo injection Q4W for 3 doses
Main sub-study AMG 108: Active Comparator N = 73	Drug: Systemic AMG 108 300 mg SC AMG 108 Q4W for 3 doses
Main sub-study placebo: Placebo Comparator 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:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040166
Study First Received:	May 16, 2005
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00110942 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Intra-articular
Osteoarthritis
OA
anakinra
Amgen

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009