NCT00664716

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jul 2007

Geographic Reach
8 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 21, 2016

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

April 21, 2008

Last Update Submit

December 17, 2015

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisRADMARD inadequate responseMethotrexate

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (1)

  • Assess the safety and tolerability of BG9924 in this participant population

    3 months

Study Arms (6)

Placebo

PLACEBO COMPARATOR

subcutaneous administration of placebo given for 12 weeks

Biological: Placebo

One Dose

EXPERIMENTAL

BG9924 - dosage level administered as per Biogen Idec protocol

Biological: Baminercept alfa 1

Second Dose

EXPERIMENTAL

BG9924 - dosage level administered as per Biogen Idec protocol

Biological: Baminercept alfa 2

Third Dose

EXPERIMENTAL

BG9924 - dosage level administered as per Biogen Idec protocol

Biological: Baminercept alfa 3

Fourth Dose

EXPERIMENTAL

BG9924 - dosage level administered as per Biogen Idec protocol

Biological: Baminercept alfa 4

Fifth Dose

EXPERIMENTAL

BG9924 - dosage level administered as per Biogen Idec protocol

Biological: Baminercept alfa 5

Interventions

Baminercept alfa 1BIOLOGICAL

experimental - one dose level

Also known as: BG9924, LT beta
One Dose
PlaceboBIOLOGICAL

Placebo comparator

Also known as: BG9924, LT beta
Placebo
Baminercept alfa 2BIOLOGICAL

experimental - second dose level

Also known as: LT beta, BG9924
Second Dose
Baminercept alfa 3BIOLOGICAL

experimental - third dose level

Also known as: BG9924, LT beta
Third Dose
Baminercept alfa 4BIOLOGICAL

experimental - fourth dose level

Also known as: BG9924, LT beta
Fourth Dose
Baminercept alfa 5BIOLOGICAL

experimental - fifth dose level

Also known as: LT beta, BG9924
Fifth Dose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Coordinating Research Site

San Miguel de Tucumán, T4000AXL, Argentina

Location

Coordinating Research Site

São Paulo, 04027-000, Brazil

Location

Coordinating Research Site

Budapest, H2143, Hungary

Location

Coordinating Research Site

Cuernavaca, 62270, Mexico

Location

Coordinating Research Site

Torun, 87100, Poland

Location

Coordinating Research Site

Brăila, 810112, Romania

Location

Coordinating Research Site

Moscow, 115522, Russia

Location

Coordinating Research Site

Leeds, Yorkshire, LS7 4SA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25405351DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Lymphotoxin-beta

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Tumor Necrosis FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 23, 2008

Study Start

July 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 21, 2016

Record last verified: 2015-12

Locations

BR(1)RO(1)AR(1)HU(1)PL(1)ME(1)RU(1)GB(1)