Rheumatoid ArthritisNCT00724672
A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)
An observational study of Rheumatoid Arthritis, run by Merck Sharp & Dohme LLC.
Trial summary
This 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to receive an anti-TNF agent will be asked to… 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, infliximab and adalimumab
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jul 2009
- 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 will be recruited from a single center at the National Institute of Rheumatology and Physiotherapy, Budapest, the largest center for biological therapy in Hungary. Subjects will be patients who are scheduled and permitted to receive anti-TNF-alpha treatment due to their rheumatoid arthritis.
Who may be able to join
- Must have active RA (DAS28 >5.1)
- Must have x-ray evidence of an erosive disease,
- Must be eligible for but have never received any anti-TNF treatment,
- Must fulfill the 1987 criteria of the American College of Rheumatology classification criteria for a diagnosis of RA, for at least 3 months,
- Must have failed standard therapy (methotrexate or leflunomide).
Who cannot join
- Must not be a women who is pregnant or breastfeeding,
- Must not have a history of any malignancy,
- Must not have an active infection,
- Must not be prone to infection,
- Must not have tuberculosis, hepatitis B, hepatitis C, or HIV,
- Must not have septic arthritis of a native prosthetic joint within the last 12 months,
- Must not have NYHA grade 3 or 4 heart failure,
- Must not have a history of demyelinating disease or systemic lupus erythematosis.
About this study
Official title: Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.
This 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to receive an anti-TNF agent will be asked to participate in this study. Patients will receive their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples collected during the study and analyzed by the laboratory. Patient's response to their treatment will also be studied based on x-rays and other examinations.
Read the detailed description
Only patients who - regardless of this study - are scheduled and permitted to receive anti-TNF-alpha treatment because of their RA will be asked to participate. No patient will be recruited only for the sake of the study. The prescribing physicians will not be influenced by the study as to what form of anti-TNF-alpha therapy they should select.
- Conditions
- Rheumatoid Arthritis
- Being tested
- etanercept, infliximab, adalimumab
- 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
Also called Enbrel®
etanercept 50 mg subcutaneously once weekly
infliximabDrug
Also called Remicade®, SCH 215596
infliximab 3 mg/kg IV at Weeks 0, 2, and 6
adalimumabDrug
Also called Humira®
adalimumab 40 mg subcutaneously biweekly
| Study group | Role | What they receive |
|---|---|---|
| ETA | RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly Receives: Drug: etanercept | |
| IFX | RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6 Receives: Drug: infliximab | |
| ADA | RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly Receives: Drug: adalimumab | |
| non-diseased controls | Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells
Measured: Weeks 0, 4, and 14.
Secondary outcomes (1)
Disease Activity measured by DAS28
Measured: Weeks 0 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
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 Merck Sharp & Dohme LLCThe 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724672
- Sponsor's protocol ID
- P05521
- Status last verified
- May 2015
- First submitted
- 25 Jul 2008
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.
- ClinicalTrials.gov ID
- NCT00724672
- Acronym / sponsor ID
- P05521
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 29 Jul 2008 (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.
This 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to receive an anti-TNF agent will be asked to participate in this study. Patients will receive their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples collected during the study and analyzed by the laboratory. Patient's response to their treatment will also be studied based on x-rays and other examinations.
Detailed description
Only patients who - regardless of this study - are scheduled and permitted to receive anti-TNF-alpha treatment because of their RA will be asked to participate. No patient will be recruited only for the sake of the study. The prescribing physicians will not be influenced by the study as to what form of anti-TNF-alpha therapy they should select.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ETA | – | Drug: etanerceptRA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly |
| IFX | – | Drug: infliximabRA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6 |
| ADA | – | Drug: adalimumabRA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly |
| non-diseased controls | – | –Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from a single center at the National Institute of Rheumatology and Physiotherapy, Budapest, the largest center for biological therapy in Hungary. Subjects will be patients who are scheduled and permitted to receive anti-TNF-alpha treatment due to their rheumatoid arthritis.
Key inclusion criteria (5 listed)
- Must have active RA (DAS28 >5.1)
- Must have x-ray evidence of an erosive disease,
- Must be eligible for but have never received any anti-TNF treatment,
- Must fulfill the 1987 criteria of the American College of Rheumatology classification criteria for a diagnosis of RA, for at least 3 months,
- Must have failed standard therapy (methotrexate or leflunomide).
Key exclusion criteria (8 listed)
- Must not be a women who is pregnant or breastfeeding,
- Must not have a history of any malignancy,
- Must not have an active infection,
- Must not be prone to infection,
- Must not have tuberculosis, hepatitis B, hepatitis C, or HIV,
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 |
|---|---|---|
| etanerceptAlso: Enbrel®etanercept 50 mg subcutaneously once weekly | Drug | ETA |
| infliximabAlso: Remicade®, SCH 215596infliximab 3 mg/kg IV at Weeks 0, 2, and 6 | Drug | IFX |
| adalimumabAlso: Humira®adalimumab 40 mg subcutaneously biweekly | Drug | ADA |
Primary outcome
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells
Time frame: Weeks 0, 4, and 14.
1 secondary outcome
Disease Activity measured by DAS28
Time frame: Weeks 0 and 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Merck Sharp & Dohme LLC.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Jun 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells (time frame: Weeks 0, 4, and 14.). 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 1 Jun 2015.