Rheumatoid Arthritis Clinical Trial
Official title:
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA
NCT number | NCT02451748 |
Other study ID # | 2015-0117 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | December 2017 |
Verified date | July 2020 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to better understand the factors present in the cells of inflamed joints of patients with arthritis that may cause rheumatoid arthritis. Knowledge gained from this study may lead to new and better therapies for arthritis.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Must meet 1987 Revised Criteria for the Classification of Rheumatoid Arthritis defined as the diagnosis of the referring physician. 2. Persistent knee swelling (>ARA grade 2) for 2 weeks, and no recent intra-articular corticosteroid injection. 3. Age 18 years and older. 4. Must be on Disease modifying anti rheumatic drugs (DMARDs) such as methotrexate, plaquenil and/or prednisone. Exclusion Criteria: 1. Patients having received intra-articular corticosteroid joint injection within the last 2-4 weeks. 2. Patients with active systemic or joint infections. 3. Women who are pregnant (pregnancy status will be self-reported) 4. Patients under 18 years of age 5. Non-English speakers |
Country | Name | City | State |
---|---|---|---|
United States | Outpatient Care Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | UCB Pharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IL-7 and IL-7R expression in peripheral blood mononuclear cells, peripheral blood monocytes or differentiated macrophages of RA patients with active vs. inactive disease treated with DMARD and/or CIMZIA. | Expression of IL-7 and IL-7R mRNA was measured in patients that were treated with or without DMARDs in RA patients by real-time RT-PCR. | RA subjects treated with (DMARDs) only, blood will only be taken once at the subjects routine visit. An expected average of 4-6 weeks. | |
Secondary | IL-7 and IL-7R expression in peripheral blood mononuclear cells, peripheral blood monocytes or differentiated macrophages of RA patients with active vs. inactive disease treated with DMARD and/or CIMZIA. | Expression of IL-7 and IL-7R mRNA was measured in RA patients that were treated with Certolizumab pegol (Cimzia®) by real-time RT-PCR. | The subjects that receive (DMARDs) plus Cimzia, blood samples will be collected onset of the study as well as 3 and 6 months. Peripheral blood mononuclear cells will be isolated from the blood and expression of IL-7 and IL-7R will be determined by real-t |
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