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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):

August 24, 2006
August 29, 2006
December 13, 2016
September 2006
June 2008   (Final data collection date for primary outcome measure)
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168 [ Time Frame: 144 Weeks ]
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
Complete list of historical versions of study NCT00369473 on ClinicalTrials.gov Archive Site
To determine whether long-term use of AMG 108 improves function in subjects with RA [ Time Frame: 144 Weeks ]
To determine whether long-term use of AMG 108 improves function in subjects with RA
Not Provided
Not Provided
 
Long-Term Assessment of Safety and Physical Function With AMG 108 in RA
A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis
The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: AMG 108
    125 mg via SC (subcutaneous) injection every 4 weeks
  • Drug: AMG 108
    250 mg via SC (subcutaneous) injection every 4 weeks
  • Experimental: 1
    350
    Intervention: Drug: AMG 108
  • Experimental: 2
    350
    Intervention: Drug: AMG 108
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
690
June 2008
June 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Belgium,   Canada,   Czech Republic,   Estonia,   France,   Hungary,   Ireland,   Italy,   Latvia,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Slovakia,   Spain,   United Kingdom,   United States
 
NCT00369473
20060119
Not Provided
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP