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Centocor Microarray Study of Patients

7 aprile 2015 aggiornato da: Christopher Ritchlin, University of Rochester

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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

31

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • New York
      • Rochester, New York, Stati Uniti, 14642
        • University of Rochester

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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 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%

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline (Wk 0) Disease Activity Score (DAS28)
Lasso di tempo: 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.
Baseline (Wk 0)
Week 10 Disease Activity Score (DAS28)
Lasso di tempo: 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.
Week 10
Disease Activity Score (DAS28) Delta
Lasso di tempo: 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.
Week 10
Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)
Lasso di tempo: 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 0)
Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)
Lasso di tempo: 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.
Week 10
Psoriasis Area and Severity Index (PASI) Delta
Lasso di tempo: 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.
Week 10

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Christopher Ritchlin, MD, University of Rochester

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2007

Completamento primario (Effettivo)

1 giugno 2010

Completamento dello studio (Effettivo)

1 agosto 2010

Date di iscrizione allo studio

Primo inviato

17 aprile 2007

Primo inviato che soddisfa i criteri di controllo qualità

17 aprile 2007

Primo Inserito (Stima)

18 aprile 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 aprile 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 aprile 2015

Ultimo verificato

1 aprile 2015

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Infliximab

3
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