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

NCT02451748 | Completed Phase 4 Results

• 1 other identifier: 2015-0117
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Expression of IL-7 and IL-7R mRNA levels measured by real-time RT-PCR.

  baseline and 3 and 6 months

Study Arms (2)

DMARD's Responder and Non-Responder

OTHER

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: Lab Work

DMARD's plus Cimzia (Certolizumab pegol)

OTHER

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.

Other: Lab Work; Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg); Drug: Certolizumab pegol (CDP870, tradename Cimzia); Drug: Hydroxychloroquine; Drug: Sulfasalazine; Drug: Medrol; Drug: Prednisone; Drug: Triamcinolone; Drug: Naproxen; Drug: Leflunomide; Drug: Methotrexate; Drug: humira

Interventions

Lab Work OTHER

Lab work to measure IL-7 and IL-7R

DMARD's Responder and Non-Responder; DMARD's plus Cimzia (Certolizumab pegol)

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.

Also known as: Certolizumab pegol

DMARD's plus Cimzia (Certolizumab pegol)

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.

Also known as: Certolizumab pegol

DMARD's plus Cimzia (Certolizumab pegol)

Hydroxychloroquine DRUG

some patients are on 400mg/day of hydroxychloroquine.

DMARD's plus Cimzia (Certolizumab pegol)

Sulfasalazine DRUG

some patients are on 300 mg/day and some patients are on 1000 mg/day dose of sulfasalazine

DMARD's plus Cimzia (Certolizumab pegol)

Medrol DRUG

some patients are on 8mg/day of medrol

DMARD's plus Cimzia (Certolizumab pegol)

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

DMARD's plus Cimzia (Certolizumab pegol)

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

DMARD's plus Cimzia (Certolizumab pegol)

Naproxen DRUG

some patients are on 1000 mg/day of naproxen

DMARD's plus Cimzia (Certolizumab pegol)

Leflunomide DRUG

some patients are on 20mg/day of leflunomide

DMARD's plus Cimzia (Certolizumab pegol)

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

DMARD's plus Cimzia (Certolizumab pegol)

humira DRUG

some patients are on Humira 40mg q2weeks

DMARD's plus Cimzia (Certolizumab pegol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must meet 1987 Revised Criteria for the Classification of Rheumatoid Arthritis defined as the diagnosis of the referring physician.
• Persistent knee swelling (\>ARA grade 2) for 2 weeks, and no recent intra-articular corticosteroid injection.
• Age 18 years and older.
• Must be on Disease modifying anti rheumatic drugs (DMARDs) such as methotrexate, plaquenil and/or prednisone.

You may not qualify if:

• Patients having received intra-articular corticosteroid joint injection within the last 2-4 weeks.
• Patients with active systemic or joint infections.
• Women who are pregnant (pregnancy status will be self-reported)
• Patients under 18 years of age
• Non-English speakers

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• UCB Pharma: collaborator

Study Sites (1)

Outpatient Care Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Kim SJ, Chang HJ, Volin MV, Umar S, Van Raemdonck K, Chevalier A, Palasiewicz K, Christman JW, Volkov S, Arami S, Maz M, Mehta A, Zomorrodi RK, Fox DA, Sweiss N, Shahrara S. Macrophages are the primary effector cells in IL-7-induced arthritis. Cell Mol Immunol. 2020 Jul;17(7):728-740. doi: 10.1038/s41423-019-0235-z. Epub 2019 Jun 13.

  PMID: 31197255 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol; Hydroxychloroquine; Sulfasalazine; Methylprednisolone; Prednisone; Triamcinolone; Naproxen; Leflunomide; Methotrexate; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Steroids, Fluorinated; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Aminopterin; Pterins; Pteridines

Limitations and Caveats

Note - total participants = 10 -- same subjects proceeded from first arm to second arm

Results Point of Contact

• Title: Shiva Shahrara, PhD
• Organization: University of Illinois at Chicago

shahrara@uic.edu

312-413-7529

Study Officials

• Shiva Shahrara, PhD

  UIC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In this study we determine whether expression of IL-7 and IL-7 receptor (R) is modulated by anti-tumor necrosis factor (TNF) treatment. For this purpose blood is obtained from RA patients prior to anti-TNF (Cimzia treatment; day 0) and after 3 months as well as 6 months of therapy. Transcription levels of IL-7 and IL-7R are examined from the peripheral blood obtained from day 0, 3 and 6 months of therapy. Results of this study will be reported in the MS in preparation.

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 22, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Locations

US (1)