Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00837434 · ClinicalTrials.gov registry record · Phase 4
Anti-TNF Agents for the Treatment of Rheumatoid Arthritis
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 63
- Enrollment target
NCT00837434 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 63 participants.
The verdict
NCT00837434, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 63 participants
- Enrollment target
Study 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.
Interventions
- DRUG Adalimumab
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-03 |
| Est. Completion | 2014-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00837434
The ClinicalTrials.gov registry entry for NCT00837434 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Adalimumab is the first listed.
NCT00837434 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00837434 about?
NCT00837434 is a clinical study titled "Anti-TNF Agents for the Treatment of Rheumatoid Arthritis". 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 o...
What is the current status of trial NCT00837434?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2009-03. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00837434?
The interventions under investigation include: Adalimumab (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT00837434?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.