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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BG00012
BG00012
placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

BG00012 480 mg/day

BG00012 720 mg/day

Outcomes

Primary Outcome Measures

The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.

Secondary Outcome Measures

To determine the safety and tolerability of BG00012 with methotrexate in this population.

Full Information

First Posted
December 17, 2008
Last Updated
September 12, 2013
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00810836
Brief Title
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
Official Title
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
BG00012 480 mg/day
Arm Title
2
Arm Type
Active Comparator
Arm Description
BG00012 720 mg/day
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BG00012
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
BG00012
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral placebo
Primary Outcome Measure Information:
Title
The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To determine the safety and tolerability of BG00012 with methotrexate in this population.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Research Site
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Research Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T4X3
Country
Canada
Facility Name
Research Site
City
New Market
Country
Canada
Facility Name
Research Site
City
Ottawa
Country
Canada
Facility Name
Research Site
City
Rothesay
Country
Canada
Facility Name
Research Site
City
Active, not recruiting
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
Country
Czech Republic
Facility Name
Research Site
City
Uh. Hradiste
Country
Czech Republic
Facility Name
Research Site
City
Zlin
Country
Czech Republic
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Hyderabaad
Country
India
Facility Name
Research Site
City
Hyderabad
Country
India
Facility Name
Research Site
City
Lucknow
Country
India
Facility Name
Research Site
City
Bialystock
Country
Poland
Facility Name
Research Site
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Warsaw
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Banska Bysterica
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Piestany
Country
Slovakia

12. IPD Sharing Statement

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

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