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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369473

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

Additional Information:
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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014