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

Rheumatoid Arthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00724672
• Other study ID #: P05521
• Status: Withdrawn
• Phase: N/A
• First received: July 25, 2008
• Last updated: May 29, 2015
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Not Applicable
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• etanercept
etanercept 50 mg subcutaneously once weekly
• infliximab
infliximab 3 mg/kg IV at Weeks 0, 2, and 6
• adalimumab
adalimumab 40 mg subcutaneously biweekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression (under- or overexpression) in the peripheral blood mononuclear cells		Weeks 0, 4, and 14.	No
Secondary	Disease Activity measured by DAS28		Weeks 0 and 14	No