Rheumatoid ArthritisPhase 4NCT00346294
An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
A Phase 4 study testing Etanercept in people with Rheumatoid Arthritis, run by Amgen.
Trial summary
An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jul 2006
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA subjects
- 18 years or older
- Currently taking etanercept in pre-filled syringes for at least 4 weeks
- Subjects must give written informed consent
- Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception
- Subject is pregnant or breast feeding
- Significant concurrent medical diseases
Who cannot join
None listed.
About this study
An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept
- Keywords
- Rheumatoid Arthritis, Device, Auto-injector, SureClick, 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.
EtanerceptDrug
Intervention type was to study the drug delivery method.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Other | Open-lable Single Arm Study Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
Measured: 22 Days
Secondary outcomes (2)
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
Measured: 22 Days
To determine the rate of failed drug deliveries (as opposed to device failures).
Measured: 22 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2006
- Study completionJul 2006
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 AmgenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346294
- Sponsor's protocol ID
- 20050207
- Status last verified
- Jan 2020
- First submitted
- 27 Jun 2006
- Last updated
- 22 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00346294
- Acronym / sponsor ID
- 20050207
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Device, Auto-injector, SureClick, Enbrel, Etanercept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation
- Study start
- Jan 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 29 Jun 2006 (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.
An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Other | Drug: EtanerceptOpen-lable Single Arm Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- RA subjects
- 18 years or older
- Currently taking etanercept in pre-filled syringes for at least 4 weeks
- Subjects must give written informed consent
- Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EtanerceptIntervention type was to study the drug delivery method. | Drug | Single-Arm |
Primary outcome
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
Time frame: 22 Days
2 secondary outcomes
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
Time frame: 22 Days
To determine the rate of failed drug deliveries (as opposed to device failures).
Time frame: 22 Days
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 22 Jan 2020.
- FDA-approved Drug LabelingLink provided by the sponsor.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept in people with Rheumatoid Arthritis, run by Amgen.
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 7 inclusion and 0 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 22 Jan 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects. (time frame: 22 Days). 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 22 Jan 2020.