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

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: August 24, 2006
Last updated: December 9, 2016
Last verified: December 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • To determine whether long-term use of AMG 108 improves function in subjects with RA [ Time Frame: 144 Weeks ]

Enrollment: 690
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: AMG 108
125 mg via SC (subcutaneous) injection every 4 weeks
Experimental: 2
Drug: AMG 108
250 mg via SC (subcutaneous) injection every 4 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00369473

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT00369473     History of Changes
Other Study ID Numbers: 20060119
Study First Received: August 24, 2006
Last Updated: December 9, 2016

Keywords provided by Amgen:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 28, 2017