Rheumatoid ArthritisPhase 3NCT02683564
BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study
A Phase 3 study testing BOW015 and Remicade in people with Rheumatoid Arthritis, run by Epirus Biopharmaceuticals (Switzerland) GmbH.
Trial summary
This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- BOW015 and Remicade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2017
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, aged 18 to 80
- Diagnosis of Rheumatoid Arthritis (RA) according to the revised ACR/ EULAR 2010 classification criteria for RA
- Patients must have ACR/EULAR 2010 classification criteria score ≥ 6
- Patients must have active disease
- Patients must have been on treatment with methotrexate
Who cannot join
- Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment
- Patients with any prior or current use of anakinra and abatacept
- Patients with suspected or confirmed current active tuberculosis (TB)
- Patients with latent tuberculosis must start treatment for latent tuberculosis
- Patients who have a current or past history of chronic infection with Hepatitis B, Hepatitis C, or infection with Human Immunodeficiency Virus-1 or-2
- History of completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma
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- History of lymphoproliferative disease
- History or presence of any other form of malignancy
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- History of congestive heart failure or unstable angina
- History of any autoimmune disease other than RA
- Major surgery within 12 weeks and planned major surgery
- History of serious infection
- Pre-existing central nervous system demyelinating disorders
- Administration of live or live-attenuated vaccine within 4 weeks of screening
- Clinically significant adverse reaction to murine or chimeric proteins
- History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality
- Participation in any clinical study of an investigational product within the previous 3 months prior to screening
Trial locations and contacts
No sites are listed yet.
EPIRUS Clinical Development contact
About this study
Official title: A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study
This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- BOW015, Remicade
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOW015Drug
Also called infliximab-EPIRUS
monoclonal antibody against TNF-alpha
RemicadeDrug
Also called infliximab
monoclonal antibody against TNF-alpha
| Study group | Role | What they receive |
|---|---|---|
| BOW015 | Experimental | Infliximab-EPIRUS, 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46. Receives: Drug: BOW015 |
| Remicade | Active comparator | Remicade (infliximab) , 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46. Receives: Drug: Remicade |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology (ACR) 20 clinical response
Measured: 16 weeks
Secondary outcomes (3)
ACR20
Measured: 54 weeks
Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP)
Measured: 54 weeks
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epirus Biopharmaceuticals (Switzerland) GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683564
- Sponsor's protocol ID
- EPI-BOW015-003
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2016
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study
- ClinicalTrials.gov ID
- NCT02683564
- Acronym / sponsor ID
- EPI-BOW015-003
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Epirus Biopharmaceuticals (Switzerland) GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jul 2017 (estimated)
- First posted
- 17 Feb 2016 (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 is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOW015 | Experimental | Drug: BOW015Infliximab-EPIRUS, 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46. |
| Remicade | Active comparator | Drug: RemicadeRemicade (infliximab) , 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female, aged 18 to 80
- Diagnosis of Rheumatoid Arthritis (RA) according to the revised ACR/ EULAR 2010 classification criteria for RA
- Patients must have ACR/EULAR 2010 classification criteria score ≥ 6
- Patients must have active disease
- Patients must have been on treatment with methotrexate
Key exclusion criteria (18 listed)
- Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment
- Patients with any prior or current use of anakinra and abatacept
- Patients with suspected or confirmed current active tuberculosis (TB)
- Patients with latent tuberculosis must start treatment for latent tuberculosis
- Patients who have a current or past history of chronic infection with Hepatitis B, Hepatitis C, or infection with Human Immunodeficiency Virus-1 or-2
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 |
|---|---|---|
| BOW015Also: infliximab-EPIRUSmonoclonal antibody against TNF-alpha | Drug | BOW015 |
| RemicadeAlso: infliximabmonoclonal antibody against TNF-alpha | Drug | Remicade |
Primary outcome
American College of Rheumatology (ACR) 20 clinical response
Time frame: 16 weeks
3 secondary outcomes
ACR20
Time frame: 54 weeks
Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP)
Time frame: 54 weeks
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: 54 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
EPIRUS Clinical Development contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BOW015 and Remicade in people with Rheumatoid Arthritis, run by Epirus Biopharmaceuticals (Switzerland) GmbH.
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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EPIRUS Clinical Development (info@epirusbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology (ACR) 20 clinical response (time frame: 16 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 17 Feb 2016.