IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

• 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
• 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)(prefilled syringes at the dose of 200mg)

Drug: Certolizumab pegol (CDP870, tradename Cimzia)

Drug: Medrol

Drug: Naproxen

Drug: Hydroxychloroquine

Drug: Methotrexate

Drug: humira

Drug: Sulfasalazine

Drug: Leflunomide

Other: Lab Work

Drug: Prednisone

Drug: Triamcinolone

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