Clinical trial NCT00110942: Treatment for Patients With Osteoarthritis (OA)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Intra-articular
Osteoarthritis
OA
anakinra
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-05-17
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in WOMAC pain score
timeFrame: Week 6
Secondary outcomes:
measure: Change in WOMAC pain score
timeFrame: Week 12
measure: Change in WOMAC composite score and function and stiffness index scores
timeFrame: Weeks 6 and 12
measure: Achieving 50% or more improvement from Day 1 in the WOMAC
timeFrame: Weeks 6 and 12
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Cohen SB, Proudman S, Kivitz AJ, Burch FX, Donohue JP, Burstein D, Sun YN, Banfield C, Vincent MS, Ni L, Zack DJ. A randomized, double-blind study of AMG 108 (a fully human monoclonal antibody to IL-1R1) in patients with osteoarthritis of the knee. Arthritis Res Ther. 2011 Jul 29;13(4):R125. doi: 10.1186/ar3430.