Rheumatoid ArthritisPhase 3NCT00249041
Enbrel Liquid Immunogenicity Protocol
A Phase 3 study testing 50 mg Etanercept and Enbrel liquid in people with Rheumatoid Arthritis, run by Amgen.
Trial summary
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis 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?
- 50 mg Etanercept and Enbrel liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Mar 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Must be able to self-inject or have someone who can do so for them
- Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value
Who cannot join
- Any prior biologic therapy for inflammatory disease
- Any prior cyclophosphamide therapy
- Not using adequate contraception
- Pregnant or breast-feeding or any significant concurrent medical condition
About this study
Official title: Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis
Read the detailed description
The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.
- Conditions
- Rheumatoid Arthritis
- Being tested
- 50 mg Etanercept, Enbrel liquid
- Keywords
- Rheumatoid Arthritis, Enbrel liquid, antibodies
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg EtanerceptDrug
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Enbrel liquidDrug
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
| Study group | Role | What they receive |
|---|---|---|
| Etanercept liquid | Experimental | Not described Receives: Drug: 50 mg Etanercept; Drug: Enbrel liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
Measured: 24 weeks
Secondary outcomes (1)
Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks.
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2006
- Study completionMar 2007
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 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 447 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
- NCT00249041
- Sponsor's protocol ID
- 20050145
- Status last verified
- Jul 2010
- First submitted
- 3 Nov 2005
- Last updated
- 30 Jul 2010
- Results posted
- No
Publications
Kavanaugh A, Lee SJ, Weng HH, Chon Y, Huang XY, Lin SL. Patient-derived joint counts are a potential alternative for determining Disease Activity Score. J Rheumatol. 2010 May;37(5):1035-41. doi: 10.3899/jrheum.090704. Epub 2010 Feb 15.
PubMed 20156946
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT00249041
- Acronym / sponsor ID
- 20050145
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Enbrel liquid, antibodies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation
- Study start
- Oct 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Nov 2005 (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.
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis
Detailed description
The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept liquid | Experimental | Drug: 50 mg Etanercept, Drug: Enbrel liquid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Must be able to self-inject or have someone who can do so for them
- Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value
Key exclusion criteria (4 listed)
- Any prior biologic therapy for inflammatory disease
- Any prior cyclophosphamide therapy
- Not using adequate contraception
- Pregnant or breast-feeding or any significant concurrent medical condition
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 |
|---|---|---|
| 50 mg Etanercept50 mg Etanercept liquid injected SC once weekly using prefilled syringes | Drug | Etanercept liquid |
| Enbrel liquid50 mg Etanercept liquid injected SC once weekly using prefilled syringes | Drug | Etanercept liquid |
Primary outcome
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
Time frame: 24 weeks
1 secondary outcome
Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks.
Time frame: 12 weeks and 24 weeks
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 30 Jul 2010.
- Results publication: PubMed 20156946Kavanaugh A, Lee SJ, Weng HH, Chon Y, Huang XY, Lin SL. Patient-derived joint counts are a potential alternative for determining Disease Activity Score. J Rheumatol. 2010 May;37(5):1035-41. doi: 10.3899/jrheum.090704. Epub 2010 Feb 15.
- 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 3 study testing 50 mg Etanercept and Enbrel liquid 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 3 inclusion and 4 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 30 Jul 2010. 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?
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?
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24 (time frame: 24 weeks). 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 NCT00249041, 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 30 Jul 2010.