A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00293826

Collaborator

(none)

813

Enrollment

Arms

23.1

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: AMG 108 Drug: AMG 108 Drug: AMG 108 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

813 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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.

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

ACR20 response [24 Weeks]

Secondary Outcome Measures

Change in subject reported outcomes [24 Weeks]
ACRn, AUC ACRn, ACR50, ACR70, and DAS28 [24 Weeks]
PK parameters [24 Weeks]
Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status [24 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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