Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants (RESPOND)

December 17, 2015 updated by: Biogen

Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.

Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

391

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

  • Argentina
      • Tucuman, Argentina, T4000AXL
        • Coordinating Research Site
  • Brazil
      • Sao Paulo, Brazil, 04027-000
        • Coordinating Research Site
  • Hungary
      • Budapest, Hungary, H2143
        • Coordinating Research Site
  • Mexico
      • Cuernavaca, Mexico, 62270
        • Coordinating Research Site
  • Poland
      • Torun, Poland, 87100
        • Coordinating Research Site
  • Romania
      • Braila, Romania, 810112
        • Coordinating Research Site
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • Coordinating Research Site
  • United Kingdom
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS7 4SA
        • Coordinating 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

Key Inclusion Criteria:

  • Diagnosis of RA (functional class I - III)
  • Stable dose of MTX
  • Inadequate response to at least one conventional DMARD therapy

Key Exclusion Criteria:

  • Serious local infection or systemic infection
  • History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment
  • Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
  • Clinical significant lab tests at screening
  • Positive for Hep C or Hep B at screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may 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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
subcutaneous administration of placebo given for 12 weeks
Biological: Placebo
Placebo comparator
Other Names:
  • BG9924
  • LT beta
Experimental: One Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 1
experimental - one dose level
Other Names:
  • BG9924
  • LT beta
Experimental: Second Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 2
experimental - second dose level
Other Names:
  • BG9924
  • LT beta
Experimental: Third Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 3
experimental - third dose level
Other Names:
  • BG9924
  • LT beta
Experimental: Fourth Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 4
experimental - fourth dose level
Other Names:
  • BG9924
  • LT beta
Experimental: Fifth Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Biological: Baminercept alfa 5
experimental - fifth dose level
Other Names:
  • BG9924
  • LT beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the safety and tolerability of BG9924 in this participant population
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104RA202

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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