Regulation of the Immune System in Response to the Treatment With Tocilizumab in RA Patients

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country50 target enrollmentJune 2010

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment: 50
Locations: 1
Primary Endpoint: Changes in the levels of phosphorylation of STAT proteins on peripheral blood leukocytes
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to know the level of expression and activation state of different transcription factors of the STAT family (STAT1, STAT3, STAT5A, STAT5B, STAT6) in the hematopoietic cells from tocilizumab treated patients.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

November 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of moderate to severe active RA of ≥6 months duration.
•Patients who have commenced treatment with Ro-Actemra® (tocilizumab) in accordance with the approved Summary of Product Characteristics.
•Age \> 18 years.
•Body weight ≤150 kg.
•Non-pregnant, non-nursing female, and females of child-bearing potential must use a reliable means of contraception, eg, physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or intrauterine device (IUD)
•If female and of childbearing potential, the patient must have a negative urine at screening and baseline.
•If patients are receiving an oral corticosteroid, the prednisone dose or its equivalent must be ≤10 mg/day and stable for ≥28 days prior to screening.
•If patients are currently taking a permitted non-biologic DMARD, the dose must be stable for ≥7 weeks prior to baseline. Willing to receive oral folate or leucovorin if taking methotrexate.
•Patients who have been given written information about the study and have consented to data collection and review.

Exclusion Criteria

•History of autoimmune disease or inflammatory joint disease other than RA.
•Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with Ro-Actemra®
•Pregnant women or nursing (breastfeeding) mothers
•Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
•Functional class IV as defined by the ACR Classification of Functional Status in RA (ie, largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care)
•Treatment with rituximab within 6 months before screening.
•Treatment with IV gamma globulin, plasmapheresis or Prosorba® column within months, or any investigational cell-depleting therapies before baseline.
•Immunization with a live/attenuated vaccine within 4 weeks prior to baseline.
•Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.
•Treatment with:

Outcomes

Primary Outcomes

Changes in the levels of phosphorylation of STAT proteins on peripheral blood leukocytes

Time Frame: 6 months

The levels of phosphorylation of STATs on different subsets of leukocytes will be assessed by flow cytometry at baseline (before Tocilizumab administration) and at the indicated time (6m) after initiation of treatment. Results will be expressed as Mean of Fluorescence Intensity. To perform the analysis the investigators will use conjugated monoclonal antibodies against STAT1, STAT3, STAT5 and STAT6