A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

NCT ID: NCT00038298

Last Updated: 2011-01-21

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

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-05-31

Brief Summary

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This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.

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

DOUBLE

Participants Investigators

Study Groups

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50 mg

50 mg 3 times weekly

Group Type EXPERIMENTAL

AMG 719

Intervention Type DRUG

50 mg 3 times weekly

400 mg

400 mg 3 times weekly

Group Type EXPERIMENTAL

AMG 719

Intervention Type DRUG

400 mg 3 times weekly

200 mg

200 mg 3 times weekly

Group Type EXPERIMENTAL

AGM 719

Intervention Type DRUG

200 mg 3 times weekly

Placebo

Placebo comparator associated with each active arm. (3:1 active vs placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo given 3 times weekly

placebo to AMG 719

Intervention Type DRUG

Placebo dose given 3 times weekly

Interventions

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Placebo

Placebo given 3 times weekly

Intervention Type DRUG

AMG 719

50 mg 3 times weekly

Intervention Type DRUG

AGM 719

200 mg 3 times weekly

Intervention Type DRUG

AMG 719

400 mg 3 times weekly

Intervention Type DRUG

placebo to AMG 719

Placebo dose given 3 times weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women, at least 18 years of age at screening
* Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse
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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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20010238

Identifier Type: -

Identifier Source: org_study_id

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