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.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00724672

Enrollment

Registered

2008-07-29

Start date

2008-09-30

Completion date

2009-07-31

Last updated

2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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.

Detailed description

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.

Interventions

DRUGetanercept

etanercept 50 mg subcutaneously once weekly

DRUGinfliximab

infliximab 3 mg/kg IV at Weeks 0, 2, and 6

DRUGadalimumab

adalimumab 40 mg subcutaneously biweekly

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells	Weeks 0, 4, and 14.

Secondary

Measure	Time frame
Disease Activity measured by DAS28	Weeks 0 and 14

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026