Rheumatoid ArthritisPhase 4NCT01301703
Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis
A Phase 4 study testing Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) in people with Rheumatoid Arthritis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients suffering from RA
- Aged 18 to 64 years old
Who cannot join
- Active disease requiring a change in drug regimen
- Known allergy to vaccine
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Rheumatology, Tel Aviv Medical Center
Tel Aviv, 64239
Ori Elkayam, M.D, 97236973668, orie@tasmc.health.gov.il
About this study
Official title: The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis
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
- Being tested
- Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
- Keywords
- rheumatoid pertussis tetanus
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)Biological
a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm
| Study group | Role | What they receive |
|---|---|---|
| Tdap vaccination | Active comparator | Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine) Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of Tdap in patients suffering from rheumatoid arthritis
Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria
Measured: 4-6 weeks after vaccination
Secondary outcomes (1)
Safety of Tdap vaccine in RA patients
Safety will be evaluated using the disease activity score (DAS) at baseline and 4-6 weeks later
Measured: 4-6 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301703
- Sponsor's protocol ID
- 0068-09
- Status last verified
- Feb 2010
- First submitted
- 21 Feb 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01301703
- Acronym / sponsor ID
- 0068-09
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid pertussis tetanus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tdap vaccination | Active comparator | Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients suffering from RA
- Aged 18 to 64 years old
Key exclusion criteria (2 listed)
- Active disease requiring a change in drug regimen
- Known allergy to vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Tdap vaccination |
Primary outcome
Immunogenicity of Tdap in patients suffering from rheumatoid arthritis
Time frame: 4-6 weeks after vaccination
Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria
1 secondary outcome
Safety of Tdap vaccine in RA patients
Time frame: 4-6 weeks after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) in people with Rheumatoid Arthritis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ori Elkayam, M.D (97236973668, orie@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity of Tdap in patients suffering from rheumatoid arthritis (time frame: 4-6 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.