COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633346
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : November 11, 2016
Roche Pharma AG
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Condition or disease
Rheumatoid Arthritis

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulation of the Immune System in Response to the Treatment With Tocilizumab in RA Patients
Study Start Date : June 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Tocilizumab treated patients
Rheumatoid arthritis patients

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633346

Layout table for location information
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Roche Pharma AG
Layout table for investigator information
Principal Investigator: Silvia Vidal, PhD Institut de Recerca de l`Hospital de la Santa Creu i Sant Pau
Layout table for additonal information
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Identifier: NCT01633346    
Other Study ID Numbers: KUL-TOC-2010-01
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases