NCT00523328

Brief Summary

This study is to observe the long-term treatment of BG9924

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
4 countries

4 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

August 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
1.1 years 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

1.2 years

First QC Date

August 17, 2007

Last Update Submit

December 17, 2015

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisArthritisBG9924methotrexate

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.

    The duration of this study is 18 months.

Study Arms (1)

BG9924

EXPERIMENTAL

dosage administered as per Biogen-idec protocol

Drug: BG9924

Interventions

BG9924DRUG

dosage administered as per Biogen-idec protocol

Also known as: LTbeta
BG9924

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 104RA203 (NCT 00458861)

You may not qualify if:

  • Participants with a significant change in medical history from their previous BG9924 Study 104RA203 (NCT 00458861).
  • Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
  • Male and female participants of child-bearing potential not willing to practice effective birth control for the duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Coordinating Research Site

Palo Alto, California, 94305, United States

Location

Coordinating Research Site

Liège, 4000, Belgium

Location

Coordinating Research Site

Toronto, Ontario, H9P 2V4, Canada

Location

Coordinating Research Site

Newcastle, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

Lymphotoxin-beta

Condition Hierarchy (Ancestors)

Joint 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2007

First Posted

August 31, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 21, 2016

Record last verified: 2015-12

Locations

BE(1)GB(1)CA(1)US(1)