NCT00110942

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2005

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

June 23, 2008

Status Verified

June 1, 2008

Enrollment Period

4 months

First QC Date

May 16, 2005

Last Update Submit

June 20, 2008

Conditions

Osteoarthritis

Keywords

Intra-articularOsteoarthritisOAanakinraAmgen

Outcome Measures

Primary Outcomes (1)

  • Change in WOMAC pain score

    Week 6

Secondary Outcomes (3)

  • Change in WOMAC pain score

    Week 12

  • Change in WOMAC composite score and function and stiffness index scores

    Weeks 6 and 12

  • Achieving 50% or more improvement from Day 1 in the WOMAC

    Weeks 6 and 12

Study Arms (4)

Minor sub-study AMG 108

ACTIVE COMPARATOR

N = 15

Drug: Systemic AMG 108

Minor sub-study placebo

PLACEBO COMPARATOR

N = 15

Other: Placebo

Main sub-study AMG 108

ACTIVE COMPARATOR

N = 73

Drug: Systemic AMG 108

Main sub-study placebo

PLACEBO COMPARATOR

N = 73

Other: Placebo

Interventions

Systemic AMG 108DRUG

300 mg SC AMG 108 Q4W for 3 doses

Main sub-study AMG 108Minor sub-study AMG 108
PlaceboOTHER

SC placebo injection Q4W for 3 doses

Main sub-study placeboMinor sub-study placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21801403DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2005

First Posted

May 17, 2005

Study Start

February 1, 2005

Primary Completion

June 1, 2005

Study Completion

November 1, 2005

Last Updated

June 23, 2008

Record last verified: 2008-06