Rheumatoid ArthritisPhase 2NCT00458861
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
A Phase 2 study testing BG9924 in people with Rheumatoid Arthritis, run by Biogen at 1 site in United States.
Trial summary
This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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
- Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
- Methotrexate (10 mg/week to 25 mg/week) > 3 months prior to Day 0 (stable dose > 4 weeks prior to Day 0)
- Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy
Who cannot join
- Medical History
- Serious local infection or systemic infection within 3 months of Day 0
- History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
- Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
- Laboratory Tests
- Clinically significant lab tests at screening; or
- Positive for hepatitis C antibody or hepatitis B at screening
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF
This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- BG9924, Placebo Comparator
- Keywords
- Active Rheumatoid Arthritis (RA)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG9924Biological
Subcutaneous administration of BG9924 given every other week for 12 weeks
Placebo ComparatorOther
Subcutaneous administration of placebo given every other week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| BG9924 | Experimental | Subcutaneous administration of BG9924 given every other week for 12 weeks Receives: Biological: BG9924 |
| Placebo | Placebo comparator | Subcutaneous administration of placebo given every other week for 12 weeks Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy
Measured: 26 weeks
Secondary outcomes (2)
Assess the safety and tolerability of BG9924 in this participant population.
Measured: 26 weeks
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Interim analysis of data 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 115 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
- NCT00458861
- Sponsor's protocol ID
- 104RA203
- Other IDs
- 2006-005467-26
- Status last verified
- Dec 2015
- First submitted
- 22 Mar 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
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF
- ClinicalTrials.gov ID
- NCT00458861
- Acronym / sponsor ID
- 104RA203
- Conditions
- Rheumatoid Arthritis
- Keywords
- Active Rheumatoid Arthritis (RA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis of data failed to meet primary endpoint.
- Enrolment
- 115 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Apr 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 Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BG9924 | Experimental | Biological: BG9924Subcutaneous administration of BG9924 given every other week for 12 weeks |
| Placebo | Placebo comparator | Other: Placebo ComparatorSubcutaneous administration of placebo given every other week for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
- Methotrexate (10 mg/week to 25 mg/week) > 3 months prior to Day 0 (stable dose > 4 weeks prior to Day 0)
- Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy
Key exclusion criteria (8 listed)
- Medical History
- Serious local infection or systemic infection within 3 months of Day 0
- History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
- Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
- Laboratory Tests
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 |
|---|---|---|
| BG9924Subcutaneous administration of BG9924 given every other week for 12 weeks | Biological | BG9924 |
| Placebo ComparatorSubcutaneous administration of placebo given every other week for 12 weeks | Other | Placebo |
Primary outcome
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy
Time frame: 26 weeks
2 secondary outcomes
Assess the safety and tolerability of BG9924 in this participant population.
Time frame: 26 weeks
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.
Time frame: 26 weeks
Results and safety
The study was stopped early (reason given: Interim analysis of data 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
1 site in 1 country: 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 1 site in United States.
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 3 inclusion and 8 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 1 site in United States. 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. Some participants in this study may receive a placebo. 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: Interim analysis of data 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?
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy (time frame: 26 weeks). 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.