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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Baminercept alfa 1
Placebo
Baminercept alfa 2
Baminercept alfa 3
Baminercept alfa 4
Baminercept alfa 5
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 Rheumatoid Arthritis, RA, DMARD inadequate response, Methotrexate

Eligibility Criteria

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

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.

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 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

One Dose

Second Dose

Third Dose

Fourth Dose

Fifth Dose

Arm Description

subcutaneous administration of placebo given for 12 weeks

BG9924 - dosage level administered as per Biogen Idec protocol

BG9924 - dosage level administered as per Biogen Idec protocol

BG9924 - dosage level administered as per Biogen Idec protocol

BG9924 - dosage level administered as per Biogen Idec protocol

BG9924 - dosage level administered as per Biogen Idec protocol

Outcomes

Primary Outcome Measures

Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy

Secondary Outcome Measures

Assess the safety and tolerability of BG9924 in this participant population

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
NCT00664716
Brief Title
Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants
Acronym
RESPOND
Official Title
Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 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
Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, RA, DMARD inadequate response, Methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
391 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
subcutaneous administration of placebo given for 12 weeks
Arm Title
One Dose
Arm Type
Experimental
Arm Description
BG9924 - dosage level administered as per Biogen Idec protocol
Arm Title
Second Dose
Arm Type
Experimental
Arm Description
BG9924 - dosage level administered as per Biogen Idec protocol
Arm Title
Third Dose
Arm Type
Experimental
Arm Description
BG9924 - dosage level administered as per Biogen Idec protocol
Arm Title
Fourth Dose
Arm Type
Experimental
Arm Description
BG9924 - dosage level administered as per Biogen Idec protocol
Arm Title
Fifth Dose
Arm Type
Experimental
Arm Description
BG9924 - dosage level administered as per Biogen Idec protocol
Intervention Type
Biological
Intervention Name(s)
Baminercept alfa 1
Other Intervention Name(s)
BG9924, LT beta
Intervention Description
experimental - one dose level
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
BG9924, LT beta
Intervention Description
Placebo comparator
Intervention Type
Biological
Intervention Name(s)
Baminercept alfa 2
Other Intervention Name(s)
LT beta, BG9924
Intervention Description
experimental - second dose level
Intervention Type
Biological
Intervention Name(s)
Baminercept alfa 3
Other Intervention Name(s)
BG9924, LT beta
Intervention Description
experimental - third dose level
Intervention Type
Biological
Intervention Name(s)
Baminercept alfa 4
Other Intervention Name(s)
BG9924, LT beta
Intervention Description
experimental - fourth dose level
Intervention Type
Biological
Intervention Name(s)
Baminercept alfa 5
Other Intervention Name(s)
LT beta, BG9924
Intervention Description
experimental - fifth dose level
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Assess the safety and tolerability of BG9924 in this participant population
Time Frame
3 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
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.
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
ZIP/Postal Code
04027-000
Country
Brazil
Facility Name
Coordinating Research Site
City
Budapest
ZIP/Postal Code
H2143
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
87100
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
115522
Country
Russian Federation
Facility Name
Coordinating Research Site
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS7 4SA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25405351
Citation
Bienkowska J, Allaire N, Thai A, Goyal J, Plavina T, Nirula A, Weaver M, Newman C, Petri M, Beckman E, Browning JL. Lymphotoxin-LIGHT pathway regulates the interferon signature in rheumatoid arthritis. PLoS One. 2014 Nov 18;9(11):e112545. doi: 10.1371/journal.pone.0112545. eCollection 2014.
Results Reference
derived

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

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