- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633346
Regulation of the Immune System in Response to the Treatment With Tocilizumab in Rheumatoid Arthritis Patients
November 10, 2016 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Regulation of the Immune System in Response to the Treatment With Tocilizumab in RA Patients
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08025
- Hospital de la Santa Creu i Sant Pau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Tocilizumab treated patients
Rheumatoid arthritis patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the levels of phosphorylation of STAT proteins on peripheral blood leukocytes
Time Frame: 6 months
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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
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Baseline, at month 6 and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Silvia Vidal, PhD, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
July 1, 2016
Study Completion (ACTUAL)
November 1, 2016
Study Registration Dates
First Submitted
June 28, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (ESTIMATE)
July 4, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
November 11, 2016
Last Update Submitted That Met QC Criteria
November 10, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUL-TOC-2010-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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