NCT00664573

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
339

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
8 countries

8 active sites

Status
terminated

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

November 1, 2007

Completed
6 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

11 months

First QC Date

April 21, 2008

Last Update Submit

December 17, 2015

Conditions

Rheumatoid Arthritis

Keywords

SafetyRheumatoid ArthritisBaminercept alfaMethotrexateBG9924Efficacy

Outcome Measures

Primary Outcomes (1)

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

    Duration of this study is 18 months

Study Arms (4)

Group 2

EXPERIMENTAL

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

Biological: Baminercept alfa (BG9924)

Group 1

EXPERIMENTAL

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

Biological: Baminercept alfa (BG9924)

Group 3

EXPERIMENTAL

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

Biological: Baminercept alfa (BG9924)

Group 4

EXPERIMENTAL

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

Biological: Baminercept alfa (BG9924)

Interventions

Baminercept alfa (BG9924)BIOLOGICAL

dosage administered as per Biogen-Idec protocol

Also known as: BG9924, Baminercept alfa, LT beta
Group 1Group 2Group 3Group 4

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

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, Brazil

Location

Coordinating Research Site

Budapest, H-1036, Hungary

Location

Coordinating Research Site

Cuernavaca, 62270, Mexico

Location

Coordinating Research Site

Torun, 87-100, Poland

Location

Coordinating Research Site

Brăila, 810112, Romania

Location

Coordinating Research Site

Moscow, 127644, Russia

Location

Coordinating Research Site

Leeds, Yorkshire, LS74SA, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baminerceptLymphotoxin-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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 23, 2008

Study Start

November 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 21, 2016

Record last verified: 2015-12

Locations

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