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.

Study Overview

• Status: Withdrawn
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: etanercept; Drug: infliximab; Drug: adalimumab

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ETA; RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly	Drug: etanercept; etanercept 50 mg subcutaneously once weekly; Other Names: Enbrel®
IFX; RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6	Drug: infliximab; infliximab 3 mg/kg IV at Weeks 0, 2, and 6; Other Names: Remicade®, SCH 215596
ADA; RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly	Drug: adalimumab; adalimumab 40 mg subcutaneously biweekly; Other Names: Humira®
non-diseased controls; Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease Activity measured by DAS28	Weeks 0 and 14

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): July 1, 2009
• Study Completion (Anticipated): July 1, 2009

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Estimate): June 1, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Etanercept; Adalimumab; Infliximab
• Other Study ID Numbers: P05521