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

September 12, 2013 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Research Site
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Research Site
  • Canada
      • New Market, Canada
        • Research Site
      • Ottawa, Canada
        • Research Site
      • Rothesay, Canada
        • Research Site
    • Ontario
      • Sarnia, Ontario, Canada, N7T4X3
        • Research Site
  • Czech Republic
      • Active, not recruiting, Czech Republic
        • Research Site
      • Pardubice, Czech Republic
        • Research Site
      • Uh. Hradiste, Czech Republic
        • Research Site
      • Zlin, Czech Republic
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Hyderabaad, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Lucknow, India
        • Research Site
  • Poland
      • Bialystock, Poland
        • Research Site
      • Grodzisk Mazowiecki, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Warsaw, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Slovakia
      • Banska Bysterica, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Piestany, Slovakia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Drug: placebo
oral placebo
Active Comparator: 1
BG00012 480 mg/day
Drug: BG00012
oral
Drug: BG00012
Oral
Active Comparator: 2
BG00012 720 mg/day
Drug: BG00012
oral
Drug: BG00012
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety and tolerability of BG00012 with methotrexate in this population.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109RA201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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