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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT02451748
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lab Work — OTHER
    Lab work to measure IL-7 and IL-7R
  • Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg) — DRUG
    Certolizumab pegol (CDP870, tradename Cimzia) or is provided in prefilled syringes at the dose of 200mg. Patients received 2x200mg at weeks 0, 2 and 4. Additionally a maintenance dose of 200mg is given every 2 weeks. Treatment is performed through subcutaneous injection.
  • Certolizumab pegol (CDP870, tradename Cimzia) — DRUG
    rtolizumab pegol (CDP870, tradename Cimzia) or is provided in prefilled syringes at the dose of 200mg. Patients received 2x200mg at weeks 0, 2 and 4. Additionally a maintenance dose of 200mg is given every 2 weeks. Treatment is performed through subcutaneous injection.
  • Hydroxychloroquine — DRUG
    some patients are on 400mg/day of hydroxychloroquine.
  • Sulfasalazine — DRUG
    some patients are on 300 mg/day and some patients are on 1000 mg/day dose of sulfasalazine
  • Medrol — DRUG
    some patients are on 8mg/day of medrol
  • Prednisone — DRUG
    some patients are on 10mg /day, some patients are on 20 mg/day, some patients are on 2.5 mg/day, some patients are on 30 mg/day, and some patients are on 5 mg/day of prednisone
  • Triamcinolone — DRUG
    some patients are on Triamcinolone 40-80mg IM monthly (received 40mg dose 1 week before blood draw, off enbrel 50mg weekly and SSZ 1000mg bid for \~ 3 months) some patients are on Triamcinolone 40mg IM monthly
  • Naproxen — DRUG
    some patients are on 1000 mg/day of naproxen
  • Leflunomide — DRUG
    some patients are on 20mg/day of leflunomide
  • Methotrexate — DRUG
    some patients are on 20mg weekly, some patients are on 25mg weekly, some patients are on 17.5 mg, some patients are on 15 mg weekly, some patients are on 7.5 mg weekly, and some patients are on 15 mg weekly dose of methotrexate
  • humira — DRUG
    some patients are on Humira 40mg q2weeks

Study Details

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.

Key Dates

Start date
Aug 31, 2015
Status verified
Jul 2024
Primary completion
Sep 30, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: DMARD's Responder and Non-Responder
    In the first group of subjects, blood samples will be obtained from (50) RA subjects with Disease modifying anti rheumatic drugs (DMARDs) such as methotrexate, plaquenil and/or prednisone that achieve remission (DAS28\<2.6). The subjects that achieve remission (DAS28\<2.6), blood will only be taken once at the subjects routine visit. Subject's that are non-responder to DMARDS will go onto group 2.
  • Other: DMARD's plus Cimzia (Certolizumab pegol)
    The second group will consist of (150) RA subjects that did not respond to "DMARDs". These patients will further receive (DMARDs) such as methotrexate, plaquenil and/or prednisone as well as Cimzia®. In this Arm, blood samples will be collected onset of the study as well as 3 and 6 months after treatment with Cimzia at subject's visit through our collaboration with the aforementioned rheumatologists.

Primary Outcome Measure

IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells of RA Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA. [ Time Frame: baseline and 3 and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Outpatient Care CenterChicagoIllinois60612-

Find similar trials in Chicago, IL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Outpatient Care Center· Chicago, IL

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