Rheumatoid ArthritisPhase 3NCT01394913
Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
A Phase 3 study testing Reumatocept (etanercept) and Enbrel (etanercept) in people with Rheumatoid Arthritis, run by EMS at 1 site in Brazil.
Trial summary
This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Reumatocept (etanercept) and Enbrel (etanercept)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Jun 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to American College of Rheumatology (ACR) criteria;
- Patients with at least 6 swollen joints
- Patients with partial response in treatment with methotrexate for 2 months
Who cannot join
- Pregnancy and Lactation
- Patients with uncontrolled hypertension
- Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus or spondyloarthritis
- Non-steroidal anti-inflammatory drug in the last 4 weeks
- Any pathology or past medical condition that can interfere with this protocol
- Patients with immunodeficiency and/or immunosuppressive disease;
- Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis.
Read the detailed description
Study design:
- Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.
Study design:
- Experiment duration: 30 weeks
- 9 visits (days 0, 14, 42, 70, 98, 126, 154, 182, 210)
- Health Assessment Questionnaire (HAQ) evaluation
- Disease Activity Score (DAS28) evaluation
- Clinical Disease Activity Index (CDAI) evaluation
- American College of Rheumatology criteria (ACR) evaluation
- Visual Activity Schedule(VAS) evaluation
- Adverse events evaluation
- Conditions
- Rheumatoid Arthritis
- Being tested
- Reumatocept (etanercept), Enbrel (etanercept)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reumatocept (etanercept)Drug
50mg each week for 30 weeks
Enbrel (etanercept)Drug
50mg each week for 30 weeks
| Study group | Role | What they receive |
|---|---|---|
| Reumatocept 25mg | Experimental | 50mg each week for 30 weeks Receives: Drug: Reumatocept (etanercept) |
| Enbrel 25mg | Active comparator | 50mg each week for 30 weeks Receives: Drug: Enbrel (etanercept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
- Health Assessment Questionnaire (HAQ)
- Disease Activity Score (DAS28)
- Clinical Disease Activity Index (CDAI)
- American College of Rheumatology criteria (ACR)
- Visual Activity Schedule(VAS)
Measured: day 1 to day 210
Secondary outcomes (1)
Safety
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: day 1 to day 210
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startAug 2013
- Primary completionMar 2014 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: Sponsor decision
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 EMSThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felipe Pinho, MD, Study director, EMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394913
- Sponsor's protocol ID
- ETAEMS0411
- Status last verified
- Feb 2021
- First submitted
- 12 Jul 2011
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01394913
- Acronym / sponsor ID
- ETAEMS0411
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 15 Jul 2011 (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 study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis.
Detailed description
Study design:
- Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.
Study design:
- Experiment duration: 30 weeks
- 9 visits (days 0, 14, 42, 70, 98, 126, 154, 182, 210)
- Health Assessment Questionnaire (HAQ) evaluation
- Disease Activity Score (DAS28) evaluation
- Clinical Disease Activity Index (CDAI) evaluation
- American College of Rheumatology criteria (ACR) evaluation
- Visual Activity Schedule(VAS) evaluation
- Adverse events evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reumatocept 25mg | Experimental | Drug: Reumatocept (etanercept)50mg each week for 30 weeks |
| Enbrel 25mg | Active comparator | Drug: Enbrel (etanercept)50mg each week for 30 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to American College of Rheumatology (ACR) criteria;
- Patients with at least 6 swollen joints
- Patients with partial response in treatment with methotrexate for 2 months
Key exclusion criteria (7 listed)
- Pregnancy and Lactation
- Patients with uncontrolled hypertension
- Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus or spondyloarthritis
- Non-steroidal anti-inflammatory drug in the last 4 weeks
- Any pathology or past medical condition that can interfere with this protocol
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 |
|---|---|---|
| Reumatocept (etanercept)50mg each week for 30 weeks | Drug | Reumatocept 25mg |
| Enbrel (etanercept)50mg each week for 30 weeks | Drug | Enbrel 25mg |
Primary outcome
Efficacy
Time frame: day 1 to day 210
1. Health Assessment Questionnaire (HAQ) 2. Disease Activity Score (DAS28) 3. Clinical Disease Activity Index (CDAI) 4. American College of Rheumatology criteria (ACR) 5. Visual Activity Schedule(VAS)
1 secondary outcome
Safety
Time frame: day 1 to day 210
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 24 Feb 2021.
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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.
Felipe Pinho, MD study director
EMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reumatocept (etanercept) and Enbrel (etanercept) in people with Rheumatoid Arthritis, run by EMS at 1 site in Brazil.
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 7 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 24 Feb 2021. 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 Brazil. 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 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?
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?
Efficacy (time frame: day 1 to day 210). 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 24 Feb 2021.