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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00462072
Date of registration: 17/04/2007
Prospective Registration: Yes
Primary sponsor: University of Rochester
Public title: Centocor Microarray Study of Patients
Scientific title: Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases
Date of first enrolment: March 2007
Target sample size: 31
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00462072
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Christopher Ritchlin, MD
Address: 
Telephone:
Email:
Affiliation:  University of Rochester
Key inclusion & exclusion criteria

Inclusion Criteria:

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

- 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 CASPARĀ® 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%

Exclusion Criteria:

- 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.

- 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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Baseline (Wk 0) Disease Activity Score (DAS28) [Time Frame: Baseline (Wk 0)]
Baseline (Wk 0) Psoriasis Area and Severity Index (PASI) [Time Frame: Baseline (Wk 0)]
Baseline (Wk 10) Psoriasis Area and Severity Index (PASI) [Time Frame: Week 10]
Disease Activity Score (DAS28) Delta [Time Frame: Week 10]
Psoriasis Area and Severity Index (PASI) Delta [Time Frame: Week 10]
Week 10 Disease Activity Score (DAS28) [Time Frame: Week 10]
Secondary Outcome(s)
Secondary ID(s)
MA-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centocor, Inc.
Ethics review
Results
Results available: Yes
Date Posted: 16/01/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00462072
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