Rheumatoid ArthritisNCT00439894
Ancillary Study to Protocol 20060104
An observational study of Rheumatoid Arthritis, run by Amgen.
Trial summary
Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment. 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?
- Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Oct 2007
- Phase
- Observational
- 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
Study population: Subjects who enrolled in to Etanercept SFP 20060104 study and signed the 20060364 informed consent.
Who may be able to join
- Signed informed Consent Meet all inclusion critieria outlined in Amgen Protocol 20060104
Who cannot join
- Meet exclusion criteria outlined in Amgen Protocol 20060104
About this study
Official title: Protein Phosphorylation Ancillary Study to Amgen Protocol 20060104: Open Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis
Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Blood draw
- Keywords
- Rheumatoid Arthritis, etanercept, Enbrel, Amgen
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
blood draw at baseline, week 12 and week 24
| Study group | Role | What they receive |
|---|---|---|
| blood draw | One time blood draw Receives: Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity.
Measured: week 24
Secondary outcomes (1)
Explore the correlations to etanercept clinical response (ACR and DAS scores) may also be explored.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionAug 2007
- Study completionOct 2007
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
- Observational
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439894
- Sponsor's protocol ID
- 20060364
- Status last verified
- Mar 2008
- First submitted
- 22 Feb 2007
- Last updated
- 21 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Phosphorylation Ancillary Study to Amgen Protocol 20060104: Open Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00439894
- Acronym / sponsor ID
- 20060364
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, etanercept, Enbrel, Amgen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 26 Feb 2007 (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.
Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood draw | – | Procedure: Blood drawOne time blood draw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who enrolled in to Etanercept SFP 20060104 study and signed the 20060364 informed consent.
Key inclusion criteria (1 listed)
- Signed informed Consent Meet all inclusion critieria outlined in Amgen Protocol 20060104
Key exclusion criteria (1 listed)
- Meet exclusion criteria outlined in Amgen Protocol 20060104
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 |
|---|---|---|
| Blood drawblood draw at baseline, week 12 and week 24 | Procedure or surgery | blood draw |
Primary outcome
To explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity.
Time frame: week 24
1 secondary outcome
Explore the correlations to etanercept clinical response (ACR and DAS scores) may also be explored.
Time frame: week 24
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 Mar 2008.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Rheumatoid Arthritis
Active, not recruitingObservational study
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Rheumatoid Arthritis, Ankylosing Spondylitis
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
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?
An observational study of 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 1 inclusion and 1 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 21 Mar 2008. 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.
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 explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity. (time frame: week 24). 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 21 Mar 2008.