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TerminatedNCT00523328Updated Jan 21, 2016

BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)

A Phase 2 interventional study of BG9924 in Rheumatoid Arthritis, sponsored by Biogen. Terminated at 4 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-21.

Sponsored by Biogen · Phase 2, Interventional, and Treatment

Why this study was terminated
Analysis of data from 104RA203 failed to meet primary endpoint.
Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

Extension study for 104RA203 (NCT 00458861)

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
  • Arthritis
  • BG9924
  • methotrexate
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 72 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.

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Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be a participant from Study 104RA203 (NCT 00458861)

Exclusion criteria

Exclusion Criteria:

  • 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.

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    BG9924

    dosage administered as per Biogen-idec protocol

    Drug: BG9924

Interventions

  • DrugBG9924

    dosage administered as per Biogen-idec protocol

    Also known as: LTbeta

06

What researchers measure

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.

    Time frame: The duration of this study is 18 months.

07

Study locations

4 sites
  • Coordinating Research Site
    Palo Alto, California 94305, United States
  • Coordinating Research Site
    Liège, 4000, Belgium
  • Coordinating Research Site
    Toronto, Ontario H9P 2V4, Canada
  • Coordinating Research Site
    Newcastle, NE1 4LP, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00523328
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Aug 31, 2007
Start date
Aug 2007
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Jan 21, 2016

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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