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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

813 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

196 subjects

Group Type EXPERIMENTAL

AMG 108

Intervention Type DRUG

50mg via SC (subcutaneous) injection every 4 weeks

3

196 subjects

Group Type EXPERIMENTAL

AMG 108

Intervention Type DRUG

250mg via SC (subcutaneous) injection every 4 weeks

2

196 subjects

Group Type EXPERIMENTAL

AMG 108

Intervention Type DRUG

125mg via SC (subcutaneous) injection every 4 weeks

4

196 subjects

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo via SC (subcutaneous) injection every 4 weeks

Interventions

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AMG 108

50mg via SC (subcutaneous) injection every 4 weeks

Intervention Type DRUG

AMG 108

250mg via SC (subcutaneous) injection every 4 weeks

Intervention Type DRUG

AMG 108

125mg via SC (subcutaneous) injection every 4 weeks

Intervention Type DRUG

Placebo

Placebo via SC (subcutaneous) injection every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No