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Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis

NCT ID: NCT00810836

Last Updated: 2013-09-16

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

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.

Detailed Description

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The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

BG00012 480 mg/day

Group Type ACTIVE_COMPARATOR

BG00012

Intervention Type DRUG

oral

2

BG00012 720 mg/day

Group Type ACTIVE_COMPARATOR

BG00012

Intervention Type DRUG

Oral

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral placebo

Interventions

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BG00012

oral

Intervention Type DRUG

BG00012

Oral

Intervention Type DRUG

placebo

oral placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* must be taking methotrexate
* inadequate response to at least one conventional DMARD
* swollen and tender joint count

Exclusion Criteria

* previous treatment with TNF or any other biologic or prosorba column

Other criteria also apply.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Biogen Idec

Locations

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Research Site

Woolloongabba, Queensland, Australia

Site Status

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Woodville, South Australia, Australia

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Sarnia, Ontario, Canada

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New Market, , Canada

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Ottawa, , Canada

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Rothesay, , Canada

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Active, Not Recruiting, , Czechia

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Pardubice, , Czechia

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Uh. Hradiste, , Czechia

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Zlín, , Czechia

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Bangalore, , India

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Hyderabaad, , India

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Hyderabad, , India

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Lucknow, , India

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Bialystock, , Poland

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Grodzisk Mazowiecki, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Banska Bysterica, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Piešťany, , Slovakia

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Countries

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Australia Canada Czechia India Poland Slovakia

Other Identifiers

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109RA201

Identifier Type: -

Identifier Source: org_study_id