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

NCT ID: NCT00369473

Last Updated: 2016-12-13

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

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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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

350

Group Type EXPERIMENTAL

AMG 108

Intervention Type DRUG

125 mg via SC (subcutaneous) injection every 4 weeks

2

350

Group Type EXPERIMENTAL

AMG 108

Intervention Type DRUG

250 mg via SC (subcutaneous) injection every 4 weeks

Interventions

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AMG 108

125 mg via SC (subcutaneous) injection every 4 weeks

Intervention Type DRUG

AMG 108

250 mg via SC (subcutaneous) injection every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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Australia Belgium Canada Czechia Estonia France Hungary Ireland Italy Latvia Mexico Netherlands Poland Puerto Rico Slovakia Spain United Kingdom United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20060119

Identifier Type: -

Identifier Source: org_study_id