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

NCT00724672 | Withdrawn

• 1 other identifier: P05521
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Gene expression (under- or overexpression) in the peripheral blood mononuclear cells

  Weeks 0, 4, and 14.

Secondary Outcomes (1)

• Disease Activity measured by DAS28

  Weeks 0 and 14

Study Arms (4)

ETA

RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly

Drug: etanercept

IFX

RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6

Drug: infliximab

ADA

RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly

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.

Interventions

etanercept DRUG

etanercept 50 mg subcutaneously once weekly

Also known as: Enbrel®

ETA

infliximab DRUG

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

Also known as: Remicade®, SCH 215596

IFX

adalimumab DRUG

adalimumab 40 mg subcutaneously biweekly

Also known as: Humira®

ADA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Infliximab; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal; Antibodies; Antibodies, Monoclonal, Humanized

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 1, 2015

Record last verified: 2015-05