Rheumatoid ArthritisPhase 4NCT00462072
Centocor Microarray Study of Patients
A Phase 4 study testing Infliximab in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Rochester at 1 site in United States.
Trial summary
Specific Aim 1. To determine the transcriptome of peripheral blood mononuclear cells isolated monocytes and target tissues in IMIDs. Specific Aim 2. To analyze the change in gene expression profiles in patients with Crohn's disease, psoriatic and rheumatoid arthritis before and after infliximab therapy. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis
- What is being tested?
- Infliximab
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Rheumatoid Arthritis
- 18 years of age or older
- 3 years duration of disease or less
- Must meet ACR criteria
- 3 tender or swollen joints
- Positive RF or anti-CCP antibodies or evidence of erosions on plain radiographs
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- CRP > 1.5
- Non-responder to methotrexate, but on a stable dose of 12.5 to 20 mg/week
- Only subjects scheduled to receive infliximab as part of their care are eligible to participate.
- Crohn's disease
- 12 years of age or older
- Clinical and endoscopic confirmation of disease
- CDAI > 220 or evidence of intestinal inflammation on endoscopy
- Documented failure to conventional therapy.
- Only subjects scheduled to receive infliximab as part of their care are eligible to participate.
- Psoriatic arthritis
- 18 years of age or older
- Must meet CASPAR® criteria for diagnosis
- RF and anti-CCP negative
- 3 tender or swollen joints
- Non-responder to methotrexate, but on a stable dose of 12.5 to 20 mg/week
- Only subjects scheduled to receive infliximab as part of their care are eligible to participate.
- Psoriasis
- 18 years of age or older
- Total BSA > 5%
Who cannot join
- Candidates for whom the procedures would be medically contraindicated would be excluded.
- Patients with any active infections (viral or bacterial) will not be considered for inclusion into the trial.
- Patients with history of chronic infection such as hepatitis, pneumonia or chronic pyelonephritis; those with current signs or symptoms of severe or progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease including demyelinating disease such as multiple sclerosis.
- Those with history of lymphoproliferative disease such as lymphoma or signs suggestive of lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, supraclavicular, epitrochlear, or periaortic areas), or splenomegaly will be excluded.
- Patients with concomitant diagnosis of CHF, including medically controlled asymptomatic patients will not be eligible to participate.
- Any current known malignancy or history of malignancy in the last 10 years will be excluded. History of basal cell carcinoma is not excluded.
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- Those with known bacterial, tuberculosis or opportunistic infections including but not limited to evidence of active cytomegalovirus , active Pneumocystis carinii, aspergillosis, or atypical mycobacterium infection within the previous 6 months will be ineligible.
- Those with known infection with Human immunodeficiency virus (HIV) or known active hepatitis B or C (including associated active hepatitis) will be excluded.
- Known substance abuse (drug or alcohol) within the previous 3 years.
- Patients who have previously taken anti-TNF therapy are not eligible.
- Patients who have been treated with DMARDS, biologic or investigational agents must wash out for at least 6 weeks prior to enrollment with the exception of those on methotrexate, who must be on a stable dose at least 2 weeks prior to start of study.
- Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
- Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
- Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
- Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases
Specific Aim 1. To determine the transcriptome of peripheral blood mononuclear cells isolated monocytes and target tissues in IMIDs.
Specific Aim 2. To analyze the change in gene expression profiles in patients with Crohn's disease, psoriatic and rheumatoid arthritis before and after infliximab therapy.
Read the detailed description
Our hypothesis is that hematopoietic stem cells are very sensitive to elevated levels of TNFa, which potentiates their differentiation into myeloid effector cells. During their migration from the bone marrow to the end organ, these cells express a unique set of genes that function to prime these cells to respond to critical differentiation signals. Elucidation of this transcriptome through microarray analysis will provide insight into novel drug targets and a formal understanding of the biochemical and molecular genetic events linking IMIDs. To test our hypothesis, will determine the transcriptome in peripheral blood mononuclear cells and isolated monocytes from 20 normal healthy donors, 10 patients with psoriatic arthritis, 10 patients with psoriasis, 10 patients with Crohn's disease and 10 patients with rheumatoid arthritis. The transcriptome will also be examined in inflamed intestinal tissue from patients with Crohn's disease, psoriatic skin and synovial tissue from patients with rheumatoid and psoriatic arthritis.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis, Crohn's Disease
- Being tested
- Infliximab
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Psoriasis, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Subjects will be on a stable dose of methotrexate 12.5 to 20 mg per week and will be started on infliximab 5 mg/kg.
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline (Wk 0) Disease Activity Score (DAS28)
The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline DAS28 is an average of the study populations baseline disease activity score prior to the administration of Infliximab (remicade). A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.
Measured: Baseline (Wk 0)
Week 10 Disease Activity Score (DAS28)
The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 DAS28 is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks. A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.
Measured: Week 10
Disease Activity Score (DAS28) Delta
The DAS28 Delta for RA and PsA subjects is measure used to determine the change in the severity of an individual's disease with positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 DAS28 Delta is determined by calculating the average change between the wk 0 and wk 10 DAS28.
Measured: Week 10
Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)
A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline PASI is an average of the study populations baseline disease activity score prior to the administration of infliximab (remicade). While higher PASI scores indicate more severe psoriasis, it is difficult for subjects or doctors to describe the clinical severity for any specific PASI number.
Measured: Baseline (Wk 0)
Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)
A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 PASI is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks.
Measured: Week 10
Psoriasis Area and Severity Index (PASI) Delta
The PASI Delta for Ps subjects is a measure used to determine the change in the severity of an individual's disease with a positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 PASI Delta is determined by calculating the average change between the wk 0 and wk 10 PASI.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Principal investigator, Christopher Ritchlin, University of Rochester
- Investigators
- Christopher Ritchlin, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462072
- Sponsor's protocol ID
- MA-01
- Status last verified
- Apr 2015
- First submitted
- 17 Apr 2007
- Last updated
- 29 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT00462072
- Acronym / sponsor ID
- MA-01
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis, Crohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Mar 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Posted 16 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aim 1. To determine the transcriptome of peripheral blood mononuclear cells isolated monocytes and target tissues in IMIDs.
Specific Aim 2. To analyze the change in gene expression profiles in patients with Crohn's disease, psoriatic and rheumatoid arthritis before and after infliximab therapy.
Detailed description
Our hypothesis is that hematopoietic stem cells are very sensitive to elevated levels of TNFa, which potentiates their differentiation into myeloid effector cells. During their migration from the bone marrow to the end organ, these cells express a unique set of genes that function to prime these cells to respond to critical differentiation signals. Elucidation of this transcriptome through microarray analysis will provide insight into novel drug targets and a formal understanding of the biochemical and molecular genetic events linking IMIDs. To test our hypothesis, will determine the transcriptome in peripheral blood mononuclear cells and isolated monocytes from 20 normal healthy donors, 10 patients with psoriatic arthritis, 10 patients with psoriasis, 10 patients with Crohn's disease and 10 patients with rheumatoid arthritis. The transcriptome will also be examined in inflamed intestinal tissue from patients with Crohn's disease, psoriatic skin and synovial tissue from patients with rheumatoid and psoriatic arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- Rheumatoid Arthritis
- 18 years of age or older
- 3 years duration of disease or less
- Must meet ACR criteria
- 3 tender or swollen joints
Key exclusion criteria (15 listed)
- Candidates for whom the procedures would be medically contraindicated would be excluded.
- Patients with any active infections (viral or bacterial) will not be considered for inclusion into the trial.
- Patients with history of chronic infection such as hepatitis, pneumonia or chronic pyelonephritis; those with current signs or symptoms of severe or progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease including demyelinating disease such as multiple sclerosis.
- Those with history of lymphoproliferative disease such as lymphoma or signs suggestive of lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, supraclavicular, epitrochlear, or periaortic areas), or splenomegaly will be excluded.
- Patients with concomitant diagnosis of CHF, including medically controlled asymptomatic patients will not be eligible to participate.
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 |
|---|---|---|
| InfliximabSubjects will be on a stable dose of methotrexate 12.5 to 20 mg per week and will be started on infliximab 5 mg/kg. | Drug | – |
Primary outcome
Baseline (Wk 0) Disease Activity Score (DAS28)
Time frame: Baseline (Wk 0)
The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline DAS28 is an average of the study populations baseline disease activity score prior to the administration of Infliximab (remicade). A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.
Week 10 Disease Activity Score (DAS28)
Time frame: Week 10
The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 DAS28 is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks. A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.
Disease Activity Score (DAS28) Delta
Time frame: Week 10
The DAS28 Delta for RA and PsA subjects is measure used to determine the change in the severity of an individual's disease with positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 DAS28 Delta is determined by calculating the average change between the wk 0 and wk 10 DAS28.
Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)
Time frame: Baseline (Wk 0)
A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline PASI is an average of the study populations baseline disease activity score prior to the administration of infliximab (remicade). While higher PASI scores indicate more severe psoriasis, it is difficult for subjects or doctors to describe the clinical severity for any specific PASI number.
Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)
Time frame: Week 10
A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 PASI is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks.
Psoriasis Area and Severity Index (PASI) Delta
Time frame: Week 10
The PASI Delta for Ps subjects is a measure used to determine the change in the severity of an individual's disease with a positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 PASI Delta is determined by calculating the average change between the wk 0 and wk 10 PASI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christopher Ritchlin, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Rochester at 1 site in United States.
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 25 inclusion and 15 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 16 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline (Wk 0) Disease Activity Score (DAS28) (time frame: Baseline (Wk 0)). The study lists 6 primary outcomes in all. 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 29 Apr 2015.