Rheumatoid ArthritisPhase 4NCT00132418
Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders
A Phase 4 study testing Enbrel in people with Rheumatoid Arthritis, run by Amgen.
Trial summary
The objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection)… 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?
- Enbrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 564 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to Feb 2004
- 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
Inclusion Criteria: - Active RA - Documented comorbid condition (diabetes mellitus requiring insulin or oral hypoglycemic agents; chronic pulmonary disease; history of pneumonia in the last year; or recurrent bronchitis, sinusitis or urinary tract infection) - Able to self-inject study drug Exclusion Criteria: - Previous use of anti-tumor necrosis factor (TNF) monoclonal antibody - Receipt of anti-CD4 or diphtheria interleukin-2 fusion protein within the previous 6 months with subsequent abnormal absolute T cell count - Receipt of intra-articular corticosteroids within 2 weeks before screening - Receipt of cyclosporine, thalidomide or azathioprine within 4 weeks before screening - Significant concurrent medical diseases (serious infection; open cutaneous ulcers; current antibiotic treatment; myocardial infarction [MI] within 12 months of screening; angina pectoris; uncontrolled hypertension; cancer; or HIV positive)
About this study
Official title: Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders
The objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Enbrel, Placebo
- Keywords
- rheumatoid arthritis and at least 1 qualifying comorbid condition (diabetes, chronic pulmonary disease, recent infection), RA, rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnbrelDrug
Enbrel
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
| Enbrel | Experimental | Enbrel Receives: Drug: Enbrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics
Measured: 16 weeks
Secondary outcomes (1)
Infections associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startApr 2000
- Primary completionFeb 2004
- Study completionFeb 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 564 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
- NCT00132418
- Sponsor's protocol ID
- 20021629
- Status last verified
- Jan 2011
- First submitted
- 19 Aug 2005
- Last updated
- 21 Jan 2011
- Results posted
- No
Publications
Weisman MH, Paulus HE, Burch FX, Kivitz AJ, Fierer J, Dunn M, Kerr DR, Tsuji W, Baumgartner SW. A placebo-controlled, randomized, double-blinded study evaluating the safety of etanercept in patients with rheumatoid arthritis and concomitant comorbid diseases. Rheumatology (Oxford). 2007 Jul;46(7):1122-5. doi: 10.1093/rheumatology/kem033. Epub 2007 Apr 29.
PubMed 17470434
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders
- ClinicalTrials.gov ID
- NCT00132418
- Acronym / sponsor ID
- 20021629
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis and at least 1 qualifying comorbid condition (diabetes, chronic pulmonary disease, recent infection), RA, rheumatoid arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation
- Study start
- Apr 2000
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 22 Aug 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 objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo |
| Enbrel | Experimental | Drug: EnbrelEnbrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EnbrelEnbrel | Drug | Enbrel |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics
Time frame: 16 weeks
1 secondary outcome
Infections associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events
Time frame: 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 21 Jan 2011.
- Results publication: PubMed 17470434Weisman MH, Paulus HE, Burch FX, Kivitz AJ, Fierer J, Dunn M, Kerr DR, Tsuji W, Baumgartner SW. A placebo-controlled, randomized, double-blinded study evaluating the safety of etanercept in patients with rheumatoid arthritis and concomitant comorbid diseases. Rheumatology (Oxford). 2007 Jul;46(7):1122-5. doi: 10.1093/rheumatology/kem033. Epub 2007 Apr 29.
- 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 Enbrel 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?
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 21 Jan 2011. 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. Some participants in this study may receive a placebo. 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?
Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics (time frame: 16 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 NCT00132418, 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 21 Jan 2011.