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

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00369473

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Rheumatoid Arthritis

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
1: Experimental 350	Drug: AMG 108 125 mg via SC (subcutaneous) injection every 4 weeks
2: Experimental 350	Drug: AMG 108 250 mg via SC (subcutaneous) injection every 4 weeks

Eligibility

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

Keywords provided by Amgen:

rheumatoid arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 12, 2009