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A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)

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ClinicalTrials.gov Identifier: NCT00724672
Recruitment Status : Withdrawn
First Posted : July 29, 2008
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

July 25, 2008
July 29, 2008
June 1, 2015
September 2008
July 2009   (Final data collection date for primary outcome measure)
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells [ Time Frame: Weeks 0, 4, and 14. ]
Same as current
Complete list of historical versions of study NCT00724672 on ClinicalTrials.gov Archive Site
Disease Activity measured by DAS28 [ Time Frame: Weeks 0 and 14 ]
Same as current
Not Provided
Not Provided
 
A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)
Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.
This 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to receive an anti-TNF agent will be asked to participate in this study. Patients will receive their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples collected during the study and analyzed by the laboratory. Patient's response to their treatment will also be studied based on x-rays and other examinations.
Only patients who - regardless of this study - are scheduled and permitted to receive anti-TNF-alpha treatment because of their RA will be asked to participate. No patient will be recruited only for the sake of the study. The prescribing physicians will not be influenced by the study as to what form of anti-TNF-alpha therapy they should select.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood samples
Non-Probability Sample
Subjects will be recruited from a single center at the National Institute of Rheumatology and Physiotherapy, Budapest, the largest center for biological therapy in Hungary. Subjects will be patients who are scheduled and permitted to receive anti-TNF-alpha treatment due to their rheumatoid arthritis.
Rheumatoid Arthritis
  • Drug: etanercept
    etanercept 50 mg subcutaneously once weekly
    Other Name: Enbrel®
  • Drug: infliximab
    infliximab 3 mg/kg IV at Weeks 0, 2, and 6
    Other Name: Remicade®, SCH 215596
  • Drug: adalimumab
    adalimumab 40 mg subcutaneously biweekly
    Other Name: Humira®
  • ETA
    RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly
    Intervention: Drug: etanercept
  • IFX
    RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6
    Intervention: Drug: infliximab
  • ADA
    RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly
    Intervention: Drug: adalimumab
  • non-diseased controls
    Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
30
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have active RA (DAS28 >5.1)
  • Must have x-ray evidence of an erosive disease,
  • Must be eligible for but have never received any anti-TNF treatment,
  • Must fulfill the 1987 criteria of the American College of Rheumatology classification criteria for a diagnosis of RA, for at least 3 months,
  • Must have failed standard therapy (methotrexate or leflunomide).

Exclusion Criteria:

  • Must not be a women who is pregnant or breastfeeding,
  • Must not have a history of any malignancy,
  • Must not have an active infection,
  • Must not be prone to infection,
  • Must not have tuberculosis, hepatitis B, hepatitis C, or HIV,
  • Must not have septic arthritis of a native prosthetic joint within the last 12 months,
  • Must not have NYHA grade 3 or 4 heart failure,
  • Must not have a history of demyelinating disease or systemic lupus erythematosis.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00724672
P05521
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2015