Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01301703
• Other study ID #: 0068-09
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 21, 2011
• Last updated: February 22, 2011
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ori Elkayam, M.D
• Phone: 97236973668
• Email: orie[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent B. pertussis infection between 8%--26% have been reported among adults with cough illness of at least 5 days duration who sought medical care. The CDC recommends vaccinating patients aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have been evaluated in healthy population, the safety and efficacy of this vaccine in patients suffering from rheumatic diseases have not been established.

Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls

Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood will be drawn at each visit at tested for humoral response to tetanus and pertussis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients suffering from RA

• Aged 18 to 64 years old

Exclusion Criteria:

• Active disease requiring a change in drug regimen

• Known allergy to vaccine

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm

Locations

Country	Name	City	State
Israel	Department of Rheumatology, Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity of Tdap in patients suffering from rheumatoid arthritis	Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria	4-6 weeks after vaccination	No
Secondary	Safety of Tdap vaccine in RA patients	Safety will be evaluated using the disease activity score (DAS) at baseline and 4-6 weeks later	4-6 weeks after vaccination	Yes