A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

March 4, 2010 updated by: Amgen

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.

The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

813

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
  • Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening

Exclusion Criteria:

  • Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
  • Presence of serious infection
  • Class IV rheumatoid arthritis
  • Prior or current history of tuberculosis infection or exposure
  • Any other DMARDs other than methotrexate within 6 weeks of screening
  • Pregnant or nursing
  • Receipt of live vaccines within 3 months
  • Felty's syndrome

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
Experimental: 1
196 subjects
Drug: AMG 108
50mg via SC (subcutaneous) injection every 4 weeks
Drug: AMG 108
250mg via SC (subcutaneous) injection every 4 weeks
Drug: AMG 108
125mg via SC (subcutaneous) injection every 4 weeks
Experimental: 3
196 subjects
Drug: AMG 108
50mg via SC (subcutaneous) injection every 4 weeks
Drug: AMG 108
250mg via SC (subcutaneous) injection every 4 weeks
Drug: AMG 108
125mg via SC (subcutaneous) injection every 4 weeks
Experimental: 2
196 subjects
Drug: AMG 108
50mg via SC (subcutaneous) injection every 4 weeks
Drug: AMG 108
250mg via SC (subcutaneous) injection every 4 weeks
Drug: AMG 108
125mg via SC (subcutaneous) injection every 4 weeks
Placebo Comparator: 4
196 subjects
Drug: Placebo
Placebo via SC (subcutaneous) injection every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACR20 response
Time Frame: 24 Weeks
24 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in subject reported outcomes
Time Frame: 24 Weeks
24 Weeks
ACRn, AUC ACRn, ACR50, ACR70, and DAS28
Time Frame: 24 Weeks
24 Weeks
PK parameters
Time Frame: 24 Weeks
24 Weeks
Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status
Time Frame: 24 Weeks
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

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.

General Publications

Helpful Links

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

March 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 5, 2010

Last Update Submitted That Met QC Criteria

March 4, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050168

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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