Rheumatoid ArthritisPhase 2EMBRACENCT01652937
BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs
A Phase 2 study testing BIIB057 in people with Rheumatoid Arthritis, run by Biogen at 3 sites in Canada.
Trial summary
Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- BIIB057
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2012to Mar 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months
- Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater
- No prior treatment with biologics
- Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening
Who cannot join
- History of inflammatory joint disease other than RA
- Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection
- History of malignancy, carcinoma in situ, or high-grade dysplasia
- History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease.
- Clinically significant cardiac disease
- Treatment with prednisone >10 mg orally daily
- Intra-articular steroid injection within 28 days before screening
- Clinically significant abnormality in hematology or blood chemistry values at screening
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Research Site
Quispamsis, New Brunswick, E2E 4J8
Research Site
Toronto, Ontario, M9W 4L6
Research Site
Winnipeg, Manitoba, R3C 3J5
About this study
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs
Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).
- Conditions
- Rheumatoid Arthritis
- Being tested
- BIIB057, Placebo
- Keywords
- Rheumatoid Arthritis, DMARD-IR
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB057Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Background Therapy | Placebo comparator | Background therapy including DMARD(s) approved by protocol Receives: Drug: Placebo |
| BIIB057 Dose 1 + Background Therapy | Experimental | Background therapy including DMARD(s) approved by protocol Receives: Drug: BIIB057 |
| BIIB057 Dose 2 + Background Therapy | Experimental | Background therapy including DMARD(s) approved by protocol Receives: Drug: BIIB057 |
| BIIB057 Dose 3 + Background Therapy | Experimental | Background therapy including DMARD(s) approved by protocol Receives: Drug: BIIB057 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)
Measured: Week 12
Secondary outcomes (3)
Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study
Measured: Up to 16 weeks
Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32
Measured: Week 12
Proportion of subjects achieving ACR50 and ACR70 response
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652937
- Sponsor's protocol ID
- 227RA201
- Acronym
- EMBRACE
- Status last verified
- Oct 2012
- First submitted
- 19 Jul 2012
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs
- ClinicalTrials.gov ID
- NCT01652937
- Acronym / sponsor ID
- EMBRACE / 227RA201
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, DMARD-IR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 30 Jul 2012 (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.
Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo + Background Therapy | Placebo comparator | Drug: PlaceboBackground therapy including DMARD(s) approved by protocol |
| BIIB057 Dose 1 + Background Therapy | Experimental | Drug: BIIB057Background therapy including DMARD(s) approved by protocol |
| BIIB057 Dose 2 + Background Therapy | Experimental | Drug: BIIB057Background therapy including DMARD(s) approved by protocol |
| BIIB057 Dose 3 + Background Therapy | Experimental | Drug: BIIB057Background therapy including DMARD(s) approved by protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months
- Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater
- No prior treatment with biologics
- Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening
Key exclusion criteria (8 listed)
- History of inflammatory joint disease other than RA
- Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection
- History of malignancy, carcinoma in situ, or high-grade dysplasia
- History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease.
- Clinically significant cardiac disease
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 |
|---|---|---|
| BIIB057Oral | Drug | BIIB057 Dose 1 + Background Therapy, BIIB057 Dose 2 + Background Therapy, BIIB057 Dose 3 + Background Therapy |
| PlaceboOral | Drug | Placebo + Background Therapy |
Primary outcome
Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)
Time frame: Week 12
3 secondary outcomes
Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study
Time frame: Up to 16 weeks
Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32
Time frame: Week 12
Proportion of subjects achieving ACR50 and ACR70 response
Time frame: Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB057 in people with Rheumatoid Arthritis, run by Biogen at 3 sites in Canada.
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 4 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: withdrawn, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline) (time frame: Week 12). 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 16 Sep 2013.