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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Show all 15Show fewer

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.

United States1 site

University of Rochester
Rochester, New York, 14642

Other trials in United States

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.

Mar 2007Aug 2010

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

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

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

Results posted to the registry on 16 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Psoriasis (Ps)	10	10
Psoriatic Arthritis (PsA)	12	12
Rheumatoid Arthritis (RA)	9	9

Primary outcome: Baseline (Wk 0) Disease Activity Score (DAS28)

Time frame: Baseline (Wk 0). Mean (Standard Deviation). Unit: Score

Measure	Psoriatic Arthritis (PsA) n = 12	Rheumatoid Arthritis (RA) n = 9
Value	4.54 (1.24)	6.03 (1.16)

Population analysed: Participant data analyzed per protocol using the following DAS28 formula \[(=0.56\*SQRT(Tender Joint Count)+0.28\*SQRT(Swollen Joint Count)+0.36\*LN(CRP(mg/L)+1)+0.014\*(Visual Analogue Scale+0.96 \]

Primary outcome: Week 10 Disease Activity Score (DAS28)

Time frame: Week 10. Mean (Standard Deviation). Unit: Score

Measure	Psoriariatic Arthritis (PsA) n = 12	Rheumatoid Arthritis (RA) n = 9
Value	3.34 (1.06)	4.13 (1.28)

Primary outcome: Disease Activity Score (DAS28) Delta

Time frame: Week 10. Mean (Standard Deviation). Unit: Score Delta

Measure	Psoriatic Arthritis (PsA) n = 12	Rheumatoid Arthritis n = 9
Value	1.21 (0.60)	1.90 (1.48)

Primary outcome: Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)

Time frame: Baseline (Wk 0). Mean (Standard Deviation). Unit: Index

Measure	Psoriasis (Ps) n = 10
Value	5.26 (1.82)

Population analysed: PASI formula PASI = 0.1 \* (erythemahead + indurationhead + desquamationhead) \* Area Scorehead + 0.2 \* (erythemaarm + indurationarm + desquamationarm) \* Area Scorearm + 0.3 \* (erythematorso + indurationtorso + desquamationtorso) \* Area Scoretorso + 0.4 \* (erythemaleg + indurationleg + desquamationleg) \* Area Scoreleg

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Psoriasis (Ps)	0 of 10 (0%)	0 of 10 (0%)	Not reported
Psoriatic Arthritis (PsA)	0 of 12 (0%)	0 of 12 (0%)	Not reported
Rheumatoid Arthritis (RA)	0 of 9 (0%)	0 of 9 (0%)	Not reported

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?

On the ClinicalTrials.gov record for NCT00462072.

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.