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

NCT ID: NCT01301703

Last Updated: 2011-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-02-29

Brief 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tdap vaccination

Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine)

Group Type: ACTIVE_COMPARATOR

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

Intervention Type: BIOLOGICAL

a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Department of Rheumatology. Tel Aviv Medical Center

Locations

Department of Rheumatology, Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Ori Elkayam, M.D

Role: CONTACT

orie@tasmc.health.gov.il

97236973668

Facility Contacts

Ori Elkayam, M.D

Role: primary

orie@tasmc.health.gov.il

97236973668

Other Identifiers

0068-09

Identifier Type: -

Identifier Source: org_study_id