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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00369473
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AMG 108 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : September 2006
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. To determine whether long-term use of AMG 108 improves function in subjects with RA [ Time Frame: 144 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369473


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

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00369473     History of Changes
Other Study ID Numbers: 20060119
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

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