Trial record 16 of 5043 for:    Open Studies | "Immune System"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01633346
First received: June 28, 2012
Last updated: February 26, 2013
Last verified: January 2013
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulation of the Immune System in Response to the Treatment With Tocilizumab in RA Patients

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Changes in the levels of phosphorylation of STAT proteins on peripheral blood leukocytes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Main change in plasma level of IL-2, IL-4, IL-6, IL-10, IL-17, TNFα, IFNα, IFNγ,MCP-1 and IL-1 [ Time Frame: Baseline, at month 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tocilizumab treated patients
Rheumatoid arthritis patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with RA who are going to commence treatment with Ro-Actemra® (Tocilizumab). All patients initiating treatment will be considered for the study if they fulfill all inclusion/exclusion criteria.

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:

Intraarticular (IA) corticosteroids within 8 weeks prior to screening. Intramuscular (IM) or IV corticosteroids within 12 weeks prior to screening.

  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
  • Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine(including uncontrolled diabetes mellitus) or GI disease (including complicated
  • Evidence of active malignant disease, malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors, except non melanoma skin cancer that has been excised and cured), or breast cancer diagnosed within the previous 5 years.
  • Active TB requiring treatment within the previous 3 years. Patients previously treated for TB with no recurrence in the past 3 years are permitted. Patients who have a positive purified protein derivative (PPD) tuberculin skin test and have not been adequately treated for TB must be treated for latent TB with isoniazid (INH) for 1 month prior to enrollment whether or not they have been vaccinated in the past. Patients with a positive PPD that is ≥5mm at screening are not eligible for the study unless they begin treatment for latent TB with INH a minimum of 1 month prior to enrollment in the trial. The required total INH treatment duration is 9 months. Patients must have a negative CXR at enrollment.
  • HIV-positive.
  • History of alcohol, drug or chemical abuse within the 6 months prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633346

Contacts
Contact: Silvia Vidal, PhD +34 93 553 75 44 svidal@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Silvia Vidal, PhD    +34 93 553 75 44    svidal@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Roche Pharma AG
Investigators
Principal Investigator: Silvia Vidal, PhD Institut de Recerca de l`Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01633346     History of Changes
Other Study ID Numbers: KUL-TOC-2010-01
Study First Received: June 28, 2012
Last Updated: February 26, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Departament de Salut de la Generalitat de Catalunya

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014