A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis - Full Text View

Purpose

The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: AMG 108 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Secondary Outcome Measures:

Change in subject reported outcomes [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
ACRn, AUC ACRn, ACR50, ACR70, and DAS28 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
PK parameters [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	813
Study Start Date:	March 2006
Study Completion Date:	February 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 196 subjects	Drug: AMG 108 50mg via SC (subcutaneous) injection every 4 weeks
Experimental: 3 196 subjects	Drug: AMG 108 250mg via SC (subcutaneous) injection every 4 weeks
Experimental: 2 196 subjects	Drug: AMG 108 125mg via SC (subcutaneous) injection every 4 weeks
Placebo Comparator: 4 196 subjects	Drug: Placebo Placebo via SC (subcutaneous) injection every 4 weeks

Eligibility

Criteria

Inclusion Criteria:

Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening

Exclusion Criteria:

Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
Presence of serious infection
Class IV rheumatoid arthritis
Prior or current history of tuberculosis infection or exposure
Any other DMARDs other than methotrexate within 6 weeks of screening
Pregnant or nursing
Receipt of live vaccines within 3 months
Felty's syndrome

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293826

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00293826 History of Changes
Other Study ID Numbers:	20050168
Study First Received:	February 17, 2006
Last Updated:	March 4, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

ACR criteria
methotrexate
DMARDs
patient reported outcomes
joint assessment

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013