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Anti-TNF Agents for the Treatment of Rheumatoid Arthritis

NCT00837434 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-09-22

Study results available
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Summary

Rheumatoid arthritis (RA) is a chronic disease that leads to inflammation and progressive joint damage. RA is a systemic inflammatory autoimmune disorder affecting almost 1% of the United States population. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. The primary purpose of this study is to determine the effectiveness of two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with RA.

Additionally, there are 4 optional sub-studies as part of the trial:

* B-Cell Kinetic Sub-Study to look at changes in B-cell subsets over time and how quickly reductions in B-cell memory occur
* Vaccine Response Sub-Study to assess B cell memory in response to immunization with hepatitis B,-hepatitis A, and diphtheria/tetanus vaccines, and to determine whether T-cell vaccine responses are altered with TNF blockade
* Tonsil Biopsy Sub-Study to evaluate how TNF blockade affects memory B-cells in the tonsil dendritic cells and germinal cells
* Synovial Biopsy Sub-Study to evaluate how TNF blockade affects changes in memory B-cells in lymphoid tissue.

Conditions

Interventions

DRUG

Etanercept

50 mg dose of etanercept by subcutaneous injection

DRUG

Adalimumab

40 mg dose of adalimumab by subcutaneous injection

Sponsors & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jennifer A. Anolik, MD, PhD · University of Rochester

  • Inaki Sanz, MD · University of Rochester

  • R. John Looney, MD · University of Rochester

  • Meggan Mackay, MD · The Feinstein Institute for Medical Research NS-LIJ Health System

  • Jeffrey Curtis, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00837434 on ClinicalTrials.gov