Rheumatoid ArthritisPhase 2RESPONDNCT00664716
Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants
A Phase 2 study testing Baminercept alfa 1, Baminercept alfa 2 and Baminercept alfa 3 in people with Rheumatoid Arthritis, run by Biogen at 8 sites in 8 countries.
Trial summary
Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) 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?
- Baminercept alfa 1, Baminercept alfa 2 and Baminercept alfa 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Jul 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 RA (functional class I - III)
- Stable dose of MTX
- Inadequate response to at least one conventional DMARD therapy
Who cannot join
- Serious local infection or systemic infection
- History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment
- Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
- Clinical significant lab tests at screening
- Positive for Hep C or Hep B at screening
- 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, LS7 4SA
About this study
Official title: Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.
Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Baminercept alfa 1, Placebo, Baminercept alfa 2, Baminercept alfa 3, Baminercept alfa 4
- Keywords
- Rheumatoid Arthritis, RA, DMARD inadequate response, Methotrexate
- 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 1Biological
Also called BG9924, LT beta
experimental - one dose level
PlaceboBiological
Also called BG9924, LT beta
Placebo comparator
Baminercept alfa 2Biological
Also called LT beta, BG9924
experimental - second dose level
Baminercept alfa 3Biological
Also called BG9924, LT beta
experimental - third dose level
Baminercept alfa 4Biological
Also called BG9924, LT beta
experimental - fourth dose level
Baminercept alfa 5Biological
Also called LT beta, BG9924
experimental - fifth dose level
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | subcutaneous administration of placebo given for 12 weeks Receives: Biological: Placebo |
| One Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol Receives: Biological: Baminercept alfa 1 |
| Second Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol Receives: Biological: Baminercept alfa 2 |
| Third Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol Receives: Biological: Baminercept alfa 3 |
| Fourth Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol Receives: Biological: Baminercept alfa 4 |
| Fifth Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol Receives: Biological: Baminercept alfa 5 |
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 (MTX) in RA participants who have had an inadequate response to DMARD therapy
Measured: 3 months
Secondary outcomes (1)
Assess the safety and tolerability of BG9924 in this participant population
Measured: 3 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 startJul 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 391 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
- NCT00664716
- Sponsor's protocol ID
- 104RA202
- Acronym
- RESPOND
- Status last verified
- Dec 2015
- First submitted
- 21 Apr 2008
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bienkowska J, Allaire N, Thai A, Goyal J, Plavina T, Nirula A, Weaver M, Newman C, Petri M, Beckman E, Browning JL. Lymphotoxin-LIGHT pathway regulates the interferon signature in rheumatoid arthritis. PLoS One. 2014 Nov 18;9(11):e112545. doi: 10.1371/journal.pone.0112545. eCollection 2014.
PubMed 25405351
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, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.
- ClinicalTrials.gov ID
- NCT00664716
- Acronym / sponsor ID
- RESPOND / 104RA202
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, RA, DMARD inadequate response, Methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 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.
Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebosubcutaneous administration of placebo given for 12 weeks |
| One Dose | Experimental | Biological: Baminercept alfa 1BG9924 - dosage level administered as per Biogen Idec protocol |
| Second Dose | Experimental | Biological: Baminercept alfa 2BG9924 - dosage level administered as per Biogen Idec protocol |
| Third Dose | Experimental | Biological: Baminercept alfa 3BG9924 - dosage level administered as per Biogen Idec protocol |
| Fourth Dose | Experimental | Biological: Baminercept alfa 4BG9924 - dosage level administered as per Biogen Idec protocol |
| Fifth Dose | Experimental | Biological: Baminercept alfa 5BG9924 - dosage level 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 (3 listed)
- Diagnosis of RA (functional class I - III)
- Stable dose of MTX
- Inadequate response to at least one conventional DMARD therapy
Key exclusion criteria (6 listed)
- Serious local infection or systemic infection
- History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment
- Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
- Clinical significant lab tests at screening
- Positive for Hep C or Hep B at screening
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 1Also: BG9924, LT betaexperimental - one dose level | Biological | One Dose |
| PlaceboAlso: BG9924, LT betaPlacebo comparator | Biological | Placebo |
| Baminercept alfa 2Also: LT beta, BG9924experimental - second dose level | Biological | Second Dose |
| Baminercept alfa 3Also: BG9924, LT betaexperimental - third dose level | Biological | Third Dose |
| Baminercept alfa 4Also: BG9924, LT betaexperimental - fourth dose level | Biological | Fourth Dose |
| Baminercept alfa 5Also: LT beta, BG9924experimental - fifth dose level | Biological | Fifth Dose |
Primary outcome
Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy
Time frame: 3 months
1 secondary outcome
Assess the safety and tolerability of BG9924 in this participant population
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Derived from this study: PubMed 25405351Bienkowska J, Allaire N, Thai A, Goyal J, Plavina T, Nirula A, Weaver M, Newman C, Petri M, Beckman E, Browning JL. Lymphotoxin-LIGHT pathway regulates the interferon signature in rheumatoid arthritis. PLoS One. 2014 Nov 18;9(11):e112545. doi: 10.1371/journal.pone.0112545. eCollection 2014.
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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 1, Baminercept alfa 2 and Baminercept alfa 3 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 3 inclusion and 6 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: finished, 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (MTX) in RA participants who have had an inadequate response to DMARD therapy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664716, which also lists 1 linked publication.
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.