Rheumatoid ArthritisPhase 2NCT00523328
BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)
A Phase 2 study testing BG9924 in people with Rheumatoid Arthritis, run by Biogen at 4 sites in 4 countries.
Trial summary
This study is to observe the long-term treatment of BG9924 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- BG9924
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a participant from Study 104RA203 (NCT 00458861)
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Coordinating Research Site
Palo Alto, California, 94305
About this study
Official title: An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects With Rheumatoid Arthritis Who Previously Participated in Study 104RA203
This study is to observe the long-term treatment of BG9924
Read the detailed description
Extension study for 104RA203 (NCT 00458861)
- Conditions
- Rheumatoid Arthritis
- Being tested
- BG9924
- Keywords
- Rheumatoid Arthritis, Arthritis, BG9924, methotrexate
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG9924Drug
Also called LTbeta
dosage administered as per Biogen-idec protocol
| Study group | Role | What they receive |
|---|---|---|
| BG9924 | Experimental | dosage administered as per Biogen-idec protocol Receives: Drug: BG9924 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.
Measured: The duration of this study is 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Analysis of data from 104RA203 failed to meet primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523328
- Sponsor's protocol ID
- 104RA205
- Other IDs
- 2007-000734-38
- Status last verified
- Dec 2015
- First submitted
- 17 Aug 2007
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects With Rheumatoid Arthritis Who Previously Participated in Study 104RA203
- ClinicalTrials.gov ID
- NCT00523328
- Acronym / sponsor ID
- 104RA205
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Arthritis, BG9924, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Analysis of data from 104RA203 failed to meet primary endpoint.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 31 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to observe the long-term treatment of BG9924
Detailed description
Extension study for 104RA203 (NCT 00458861)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BG9924 | Experimental | Drug: BG9924dosage administered as per Biogen-idec protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a participant from Study 104RA203 (NCT 00458861)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG9924Also: LTbetadosage administered as per Biogen-idec protocol | Drug | BG9924 |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Analysis of data from 104RA203 failed to meet primary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BG9924 in people with Rheumatoid Arthritis, run by Biogen at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Analysis of data from 104RA203 failed to meet primary endpoint.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.