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Long-Term Assessment of Safety and Physical Function With AMG 108 in RA

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00369473
First received: August 24, 2006
Last updated: April 9, 2009
Last verified: April 2009
History of Changes
  Purpose

The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: AMG 108
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168 [ Time Frame: 144 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine whether long-term use of AMG 108 improves function in subjects with RA [ Time Frame: 144 Weeks ] [ Designated as safety issue: No ]

Enrollment: 690
Study Start Date: September 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
350
 Drug: AMG 108
125 mg via SC (subcutaneous) injection every 4 weeks
Experimental: 2
350
 Drug: AMG 108
250 mg via SC (subcutaneous) injection every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll.

Exclusion Criteria:

  • Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369473

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

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

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00369473     History of Changes
Other Study ID Numbers: 20060119
Study First Received: August 24, 2006
Last Updated: April 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013