Centocor Microarray Study of Patients

NCT00462072 | Completed Phase 4 Results

• 1 other identifier: MA-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Psoriasis; Crohn's Disease

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Week 10

Interventions

Infliximab DRUG

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.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Rheumatoid Arthritis
• years of age or older
• years duration of disease or less
• Must meet ACR criteria
• 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
• 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.

You may not qualify if:

• Candidates for whom the procedures would be medically contraindicated would be excluded.
• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Centocor, Inc.: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Rick Barrett
• Organization: University of Rochester

rick_barrett@urmc.rochester.edu

585-275-1647

Study Officials

• Christopher Ritchlin, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.P.H.; Professor of Medicine Allergy, Immunology & Rheumatology Division

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 29, 2015
• Results First Posted: January 16, 2012

Record last verified: 2015-04

Locations

US (1)