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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00724672
First received: July 25, 2008
Last updated: November 24, 2008
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
 Drug: etanercept
Drug: infliximab
Drug: adalimumab

Study Type: Observational
Study Design: Time Perspective: Prospective
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Gene expression (under- or overexpression) in the peripheral blood mononuclear cells [ Time Frame: Weeks 0, 4, and 14. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease Activity measured by DAS28 [ Time Frame: Weeks 0 and 14 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ETA
RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly
 Drug: etanercept
etanercept 50 mg subcutaneously once weekly
Other Name: 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 Name: Remicade®, SCH 215596
ADA
RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly
 Drug: adalimumab
adalimumab 40 mg subcutaneously biweekly
Other Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00724672     History of Changes
Other Study ID Numbers: P05521
Study First Received: July 25, 2008
Last Updated: November 24, 2008
Health Authority: Hungary: Not Applicable

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Infliximab
Adalimumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013