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104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants (RESPOND-EXT)

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Baminercept alfa (BG9924)
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Safety, Rheumatoid Arthritis, Baminercept alfa, Methotrexate, BG9924, Efficacy

Eligibility Criteria

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

Inclusion Criteria:

  • Must be a participant from Study 104RA202 (NCT 00664716)
  • Stable dose of Methotrexate for the duration of the study

Exclusion Criteria:

  • Participants with a significant change in their medical history from their previous BG9924 study
  • Any clinically significant infectious illness or serious local infection

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Coordinating Research Site
  • Coordinating Research Site
  • Coordinating Research Site
  • Coordinating Research Site
  • Coordinating Research Site
  • Coordinating Research Site
  • Coordinating Research Site
  • Coordinating Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 2

Group 1

Group 3

Group 4

Arm Description

Drug: BG9924 - dose administered as per Biogen-Idec protocol

Drug: BG9924 - dose administered as per Biogen-Idec protocol

Drug: BG9924 - dose administered as per Biogen-Idec protocol

Drug: BG9924 - dose administered as per Biogen-Idec protocol

Outcomes

Primary Outcome Measures

To Observe The Long-Term treatment with BG9924 When Administered to Participants with RA who Previously Participated in a Biogen Idec Study

Secondary Outcome Measures

Full Information

First Posted
April 21, 2008
Last Updated
December 17, 2015
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00664573
Brief Title
104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants
Acronym
RESPOND-EXT
Official Title
Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Analysis of data from 104RA202 failed to meet primary endpoint
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Safety, Rheumatoid Arthritis, Baminercept alfa, Methotrexate, BG9924, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Experimental
Arm Description
Drug: BG9924 - dose administered as per Biogen-Idec protocol
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Drug: BG9924 - dose administered as per Biogen-Idec protocol
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Drug: BG9924 - dose administered as per Biogen-Idec protocol
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Drug: BG9924 - dose administered as per Biogen-Idec protocol
Intervention Type
Biological
Intervention Name(s)
Baminercept alfa (BG9924)
Other Intervention Name(s)
BG9924, Baminercept alfa, LT beta
Intervention Description
dosage administered as per Biogen-Idec protocol
Primary Outcome Measure Information:
Title
To Observe The Long-Term treatment with BG9924 When Administered to Participants with RA who Previously Participated in a Biogen Idec Study
Time Frame
Duration of this study is 18 months

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 a participant from Study 104RA202 (NCT 00664716) Stable dose of Methotrexate for the duration of the study Exclusion Criteria: Participants with a significant change in their medical history from their previous BG9924 study Any clinically significant infectious illness or serious local infection NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Coordinating Research Site
City
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Coordinating Research Site
City
Sao Paulo
Country
Brazil
Facility Name
Coordinating Research Site
City
Budapest
ZIP/Postal Code
H-1036
Country
Hungary
Facility Name
Coordinating Research Site
City
Cuernavaca
ZIP/Postal Code
62270
Country
Mexico
Facility Name
Coordinating Research Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Coordinating Research Site
City
Braila
ZIP/Postal Code
810112
Country
Romania
Facility Name
Coordinating Research Site
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Coordinating Research Site
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS74SA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants

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