Rheumatoid ArthritisPhase 2NCT01131910
TBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs
A Phase 2 study testing TBE-vaccine and Vaccination against TBE in people with Rheumatoid Arthritis and Exposed to TBE-virus, run by Sormland County Council, Sweden at 6 sites in 2 countries.
Trial summary
The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Exposed to TBE-virus, Immunosuppression
- What is being tested?
- TBE-vaccine and Vaccination against TBE
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 6 sitesin 2 countries
- Study dates
- May 2010to May 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs
- Interest to be vaccinated
- Written consent
- Age 18 years or more
Who cannot join
- Previous TBE-infection
- Previous Vaccination with TBE
- Pregnancy
- Breast feeding
- Treatment with rituximab the last 9 months
- Inability to follow study protocol
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Sweden5 sites
Dept infectious diseases
Eskilstuna, 631 88
Dept. infectious diseases
Eskilstuna, 631 88
Department of infectious diseases
Örebro
Department of infectious diseases
Stockholm, 17176
Dept infectious diseases
Uppsala, 751 85
About this study
Official title: Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs
The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. The investigators aim to detect a difference of at least 10 % compared to healthy individuals (historical controls) in protection when analysed with serology. If the investigators detect a difference, the investigators will continue to explore whether protection can be achieved by additional doses
- Being tested
- TBE-vaccine, Vaccination against TBE
- Keywords
- Rheumatoid arthritis, TBE-vaccine, Immunosuppression
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBE-vaccineBiological
Also called ATC-code J07B A01
Solution of 0.5 ml for intramuscular use. Given in 2 doses separated by 1 month to healthy individuals less than 60 years old. (3 doses 0+1+3 months to those are 60 and above in Sweden)
TBE-vaccineBiological
Also called J07B A01
Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year
Vaccination against TBEBiological
0.5 ml im at 0 and 1 month ( less than 60 years old) or 0 and 1 and 3 months (at least 60 years old)
| Study group | Role | What they receive |
|---|---|---|
| Vaccination against TBE | Experimental | Less than 60 years old: Two doses of TBE- vaccine separated by a month and a third dose 12 months after the first dose
60 years and above: Three doses, given at 0+1+3 months and a 4 th dose 12 months after the first dose Receives: Biological: TBE-vaccine; Biological: Vaccination against TBE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
The humoral response to TBE-vaccine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sormland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Investigators
- Lars Rombo, MD Professor, Principal investigator, Somland county council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131910
- Sponsor's protocol ID
- 2010-019438-28
- Status last verified
- Apr 2010
- First submitted
- 24 May 2010
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs
- ClinicalTrials.gov ID
- NCT01131910
- Acronym / sponsor ID
- 2010-019438-28
- Keywords
- Rheumatoid arthritis, TBE-vaccine, Immunosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sormland County Council, SwedenUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 May 2010 (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.
The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. The investigators aim to detect a difference of at least 10 % compared to healthy individuals (historical controls) in protection when analysed with serology. If the investigators detect a difference, the investigators will continue to explore whether protection can be achieved by additional doses
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination against TBE | Experimental | Biological: TBE-vaccine, Biological: Vaccination against TBELess than 60 years old: Two doses of TBE- vaccine separated by a month and a third dose 12 months after the first dose 60 years and above: Three doses, given at 0+1+3 months and a 4 th dose 12 months after the first dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs
- Interest to be vaccinated
- Written consent
- Age 18 years or more
Key exclusion criteria (6 listed)
- Previous TBE-infection
- Previous Vaccination with TBE
- Pregnancy
- Breast feeding
- Treatment with rituximab the last 9 months
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 |
|---|---|---|
| TBE-vaccineAlso: ATC-code J07B A01Solution of 0.5 ml for intramuscular use. Given in 2 doses separated by 1 month to healthy individuals less than 60 years old. (3 doses 0+1+3 months to those are 60 and above in Sweden) | Biological | Vaccination against TBE |
| TBE-vaccineAlso: J07B A01Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year | Biological | Vaccination against TBE |
| Vaccination against TBE0.5 ml im at 0 and 1 month ( less than 60 years old) or 0 and 1 and 3 months (at least 60 years old) | Biological | Vaccination against TBE |
Primary outcome
Seroconversion rate
Time frame: 1 year
The humoral response to TBE-vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 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.
Lars Rombo, MD Professor principal investigator
Somland county council
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TBE-vaccine and Vaccination against TBE in people with Rheumatoid Arthritis and Exposed to TBE-virus, run by Sormland County Council, Sweden at 6 sites in 2 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Finland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate (time frame: 1 year). 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 25 May 2011.