Rheumatoid ArthritisPhase 4NCT00099554
Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
A Phase 4 study testing Etanercept in people with Rheumatoid Arthritis, run by Amgen.
Trial summary
The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects achieving a "good" or "moderate" DAS28 response (EULAR28 criteria) at Week 16 with etanercept 50 mg subcutaneously (SC) once weekly in patients who have failed infliximab. 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
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2004to not given
- 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
- Adults with RA (ACR criteria) for greater than or equal to 6 months
- Infliximab treatment for at least 18 weeks
- Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every 4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency)
- Failing infliximab defined by ALL of the following at screening and baseline visit: Disease Activity Score (DAS 28) greater than or equal to 4.5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints
- Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or equal to 10 mg/week at least 10 weeks prior to screening
- Stable disease modifying anti-rheumatic drugs (DMARD) therapy (including sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to screening
- Stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks prior to screening
- Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) greater than or equal to 1 week prior to screening
Who cannot join
- ACR functional class IV - Prior treatment with etanercept
- Receipt of any investigational drug/biologic within 28 days of study drug initiation
- Active infection or predisposition to infection
- Elective surgery planned during study period
- Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4 weeks prior to screening
- Contraindications to etanercept as defined in the package insert
- Severe co-morbidities: History of cancer within 5 years; Diagnosis of class III or IV congestive heart failure (CHF); Uncontrolled hypertension (HTN); CNS-demyelinating events suggestive of multiple sclerosis (MS); Known HIV-positive status; Oxygen-dependent pulmonary status; Chronic hepatitis B or C; Systemic Lupus Erythematosus (SLE); Active or prior history of tuberculosis (TB) (or known exposure) or positive PPD without adequate TB prophylaxis
About this study
Official title: A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects achieving a "good" or "moderate" DAS28 response (EULAR28 criteria) at Week 16 with etanercept 50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.
- Conditions
- Rheumatoid Arthritis
- Being tested
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
Secondary outcomes (5)
Proportion of subjects who achieve ACR 20, 50, and 70 responses at Weeks 8 and 16.
Proportion of subjects who achieve good or moderate DAS28 response at Week 8 and the proportion who achieve remission (DAS28 less than 2.6) at Weeks 8 and 16
Absolute and percent changes from baseline in components of the ACR and DAS28 criteria (including HAQ) at Weeks 8 and 16.
Absolute changes from baseline in SF-36 and Valued Life Activities at Weeks 8 and 16
Subject incidence rate of SAEs over 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2004 (estimated)
- Study startMay 2004
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099554
- Sponsor's protocol ID
- 20030236
- Status last verified
- Nov 2009
- First submitted
- 16 Dec 2004
- Last updated
- 13 Nov 2009
- Results posted
- No
Publications
Bingham CO 3rd, Ince A, Haraoui B, Keystone EC, Chon Y, Baumgartner S. Effectiveness and safety of etanercept in subjects with RA who have failed infliximab therapy: 16-week, open-label, observational study. Curr Med Res Opin. 2009 May;25(5):1131-42. doi: 10.1185/03007990902841010.
PubMed 19317607
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
- ClinicalTrials.gov ID
- NCT00099554
- Acronym / sponsor ID
- 20030236
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2004
- First posted
- 17 Dec 2004 (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 evaluate the proportion of Rheumatoid Arthritis (RA) subjects achieving a "good" or "moderate" DAS28 response (EULAR28 criteria) at Week 16 with etanercept 50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults with RA (ACR criteria) for greater than or equal to 6 months
- Infliximab treatment for at least 18 weeks
- Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every 4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency)
- Failing infliximab defined by ALL of the following at screening and baseline visit: Disease Activity Score (DAS 28) greater than or equal to 4.5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints
- Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or equal to 10 mg/week at least 10 weeks prior to screening
Key exclusion criteria (7 listed)
- ACR functional class IV - Prior treatment with etanercept
- Receipt of any investigational drug/biologic within 28 days of study drug initiation
- Active infection or predisposition to infection
- Elective surgery planned during study period
- Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4 weeks prior to screening
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 |
|---|---|---|
| Etanercept | Drug | – |
Primary outcome
Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
5 secondary outcomes
Proportion of subjects who achieve ACR 20, 50, and 70 responses at Weeks 8 and 16.
Proportion of subjects who achieve good or moderate DAS28 response at Week 8 and the proportion who achieve remission (DAS28 less than 2.6) at Weeks 8 and 16
Absolute and percent changes from baseline in components of the ACR and DAS28 criteria (including HAQ) at Weeks 8 and 16.
Absolute changes from baseline in SF-36 and Valued Life Activities at Weeks 8 and 16
Subject incidence rate of SAEs over 16 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 13 Nov 2009.
- Results publication: PubMed 19317607Bingham CO 3rd, Ince A, Haraoui B, Keystone EC, Chon Y, Baumgartner S. Effectiveness and safety of etanercept in subjects with RA who have failed infliximab therapy: 16-week, open-label, observational study. Curr Med Res Opin. 2009 May;25(5):1131-42. doi: 10.1185/03007990902841010.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink 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 8 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: finished, as of the sponsor's last update on 13 Nov 2009. 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?
Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.. 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 NCT00099554, 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 13 Nov 2009.