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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02451748
Date of registration: 06/05/2015
Prospective Registration: Yes
Primary sponsor: University of Illinois at Chicago
Public title: IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA
Scientific 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
Date of first enrolment: August 2015
Target sample size: 32
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02451748
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Factorial Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Shiva Shahrara, PhD
Address: 
Telephone:
Email:
Affiliation:  UIC
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Certolizumab pegol (CDP870, tradename Cimzia)
Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg)
Drug: humira
Drug: Hydroxychloroquine
Drug: Leflunomide
Drug: Medrol
Drug: Methotrexate
Drug: Naproxen
Drug: Prednisone
Drug: Sulfasalazine
Drug: Triamcinolone
Other: Lab Work
Primary Outcome(s)
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. [Time Frame: 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 Outcome(s)
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. [Time Frame: 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]
Secondary ID(s)
2015-0117
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
UCB Pharma
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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