Rheumatoid ArthritisPhase 2RESPOND-EXTNCT00664573
104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants
A Phase 2 study testing Baminercept alfa (BG9924) in people with Rheumatoid Arthritis, run by Biogen at 8 sites in 8 countries.
Trial summary
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study. 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?
- Baminercept alfa (BG9924)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Nov 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 104RA202 (NCT 00664716)
- Stable dose of Methotrexate for the duration of the study
Who cannot join
- Participants with a significant change in their medical history from their previous BG9924 study
- Any clinically significant infectious illness or serious local infection
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
United Kingdom1 site
Coordinating Research Site
Leeds, Yorkshire, LS74SA
About this study
Official title: Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Baminercept alfa (BG9924)
- Keywords
- Safety, Rheumatoid Arthritis, Baminercept alfa, Methotrexate, BG9924, Efficacy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baminercept alfa (BG9924)Biological
Also called BG9924, Baminercept alfa, LT beta
dosage administered as per Biogen-Idec protocol
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | Drug: BG9924 - dose administered as per Biogen-Idec protocol Receives: Biological: Baminercept alfa (BG9924) |
| Group 1 | Experimental | Drug: BG9924 - dose administered as per Biogen-Idec protocol Receives: Biological: Baminercept alfa (BG9924) |
| Group 3 | Experimental | Drug: BG9924 - dose administered as per Biogen-Idec protocol Receives: Biological: Baminercept alfa (BG9924) |
| Group 4 | Experimental | Drug: BG9924 - dose administered as per Biogen-Idec protocol Receives: Biological: Baminercept alfa (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: 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 posted23 Apr 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Analysis of data from 104RA202 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 339 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
- NCT00664573
- Sponsor's protocol ID
- 104RA204
- Other IDs
- 2007-000733-19
- Acronym
- RESPOND-EXT
- Status last verified
- Dec 2015
- First submitted
- 21 Apr 2008
- 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
- Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.
- ClinicalTrials.gov ID
- NCT00664573
- Acronym / sponsor ID
- RESPOND-EXT / 104RA204
- Conditions
- Rheumatoid Arthritis
- Keywords
- Safety, Rheumatoid Arthritis, Baminercept alfa, Methotrexate, BG9924, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Analysis of data from 104RA202 failed to meet primary endpoint
- Enrolment
- 339 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Apr 2008 (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.
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Biological: Baminercept alfa (BG9924)Drug: BG9924 - dose administered as per Biogen-Idec protocol |
| Group 1 | Experimental | Biological: Baminercept alfa (BG9924)Drug: BG9924 - dose administered as per Biogen-Idec protocol |
| Group 3 | Experimental | Biological: Baminercept alfa (BG9924)Drug: BG9924 - dose administered as per Biogen-Idec protocol |
| Group 4 | Experimental | Biological: Baminercept alfa (BG9924)Drug: BG9924 - dose 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 (2 listed)
- Must be a participant from Study 104RA202 (NCT 00664716)
- Stable dose of Methotrexate for the duration of the study
Key exclusion criteria (3 listed)
- Participants with a significant change in their medical history from their previous BG9924 study
- Any clinically significant infectious illness or serious local infection
- 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 |
|---|---|---|
| Baminercept alfa (BG9924)Also: BG9924, Baminercept alfa, LT betadosage administered as per Biogen-Idec protocol | Biological | Group 1, Group 2, Group 3, Group 4 |
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: Duration of this study is 18 months
Results and safety
The study was stopped early (reason given: Analysis of data from 104RA202 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
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baminercept alfa (BG9924) in people with Rheumatoid Arthritis, run by Biogen at 8 sites in 8 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 2 inclusion and 3 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 8 sites in Argentina, Brazil, Hungary, Mexico, Poland and 3 more countries. 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 104RA202 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: 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.