Effect of Tocilizumab to the Cellular Immune Response to Influenza Vaccine

NCT01980836 | Unknown Phase 4

• 1 other identifier: TASMC-13-OE-245-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with rheumatoid arthritis (RA) are prone to respiratory infections and therefore recommmended to receive vaccination against seasonal influenza. We and others have shown a relatively preserved humoral response to vaccination in RA patients. However, the cellular response as well as the effect of biologics such as tocilizumab on the cellular response has not been weel studied. The purpose of this study is the evaluate the effect of tocilizumab on the cellular immune response to influenza vaccine in patients with RA in comparison with healthy controls

Conditions

Rheumatoid Arthritis; Cellular Immune Response

Keywords

Rheumatoid arthritis; Tocilizumab; Seasonal influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Cellular response

  As described in the study design using the Interferin gamma and granzyme B levels

  4 weeks

Secondary Outcomes (1)

• Humoral response

  4 weeks

Study Arms (2)

Seasonal influenza vaccine in tocilizumab treated RA patients

ACTIVE COMPARATOR

RA patients treated with tocilizumab

Biological: Seasonal influenza vaccine

Seasonal influenza vaccine to Healthy controls

ACTIVE COMPARATOR

Healthy controls will be vaccinated against seasonal influenza

Biological: Seasonal influenza vaccine

Interventions

Seasonal influenza vaccine BIOLOGICAL

Seasonal influenza vaccine in tocilizumab treated RA patients; Seasonal influenza vaccine to Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rheumatoid Arthritis patients treated with Tocilizumab for at least 3 months
• Above the age of 18

You may not qualify if:

• Allergy to eggs

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (2)

• Elkayam O, Amir S, Mendelson E, Schwaber M, Grotto I, Wollman J, Arad U, Brill A, Paran D, Levartovsky D, Wigler I, Caspi D, Mandelboim M. Efficacy and safety of vaccination against pandemic 2009 influenza A (H1N1) virus among patients with rheumatic diseases. Arthritis Care Res (Hoboken). 2011 Jul;63(7):1062-7. doi: 10.1002/acr.20465.

  PMID: 21425247 BACKGROUND

• Arad U, Tzadok S, Amir S, Mandelboim M, Mendelson E, Wigler I, Sarbagil-Maman H, Paran D, Caspi D, Elkayam O. The cellular immune response to influenza vaccination is preserved in rheumatoid arthritis patients treated with rituximab. Vaccine. 2011 Feb 11;29(8):1643-8. doi: 10.1016/j.vaccine.2010.12.072. Epub 2011 Jan 4.

  PMID: 21211590 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ori Elkayam Elkayam, M.D

CONTACT

97236973668; ORIE@TLVMC.GOV.IL

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

IL (1)