Arthritis, RheumatoidNCT01947465
Immunogenicity and Safety of Vaccinations in Immunocompromised Persons
An observational study of Arthritis, Rheumatoid and Spondylarthritis, run by University of Zurich at 10 sites in Switzerland.
Trial summary
Backgound and relevance of the project: Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of contracting infections. The increased risk can be attributed to the immunological disorder itself, as well as to the immunosuppressive treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid, Spondylarthritis, Vasculitis
- What is being tested?
- Hepatitis A vaccine and tetanus vaccine
- Type of treatment
- Vaccines
- How many people
- 645 participants
- Where
- 10 sitesSwitzerland
- Study dates
- Oct 2013to Feb 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohort will be selected from patients with rheumatic diseases under treatment at 6 rheumatology outpatient clinics in Switzerland (University of Basel, University of Bern, University of Geneva, University of Zurich, Cantonal Hospital Aarau, Cantonal Hospital St. Gallen)
Who may be able to join
- Indication for hepatitis A and/or tetanus vaccination according to Swiss Federal Office of Public Health recommendations
- Male and female rheumatic patients with rheumatoid arthritis or axial spondyloarthritis (ankylosing spondylitis, axial psoriatic arthritis, axial undifferentiated spondyloarthritis, enteropahtic arthritis) or peripheral psoriatic arthritis or vasculitis (Behçet's disease or ANCA-associated vasculitis) or male and female healthy participants ≥ 18 years
- Signed Informed Consent after being informed
Who cannot join
- Known hypersensitivity to a vaccine ingredient
- Estimated patient survival below 1 year
- Active malignant or active infectious disease
- Drug/alcohol abuse
- Insufficient understanding of local language
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Switzerland10 sites
Cantonal Hospital Aarau, Division of Rheumatology
Aarau, Canton of Aargau, 5001
University Hospital of Basel, Rheumatology Division
Basel, Basel Town, 4031
Swiss Tropical and Public Health Institute
Basel, Basel Town, 4051
University of Bern, Inselspital, Division of Infectious Diseases and Travel Medicine
Bern, Canton of Bern, 3010
University of Bern, Inselspital, Division of Rheumatology
Bern, Canton of Bern, 3010
University of Geneva, University Hospitals, Division of Rheumatology
Geneva, Canton of Geneva, 1211
University of Geneva, University Hospitals, Service de Médecine Tropicale et Humanitaire
Geneva, Canton of Geneva, 1211
Cantonal Hospital St. Gallen, Division of Rheumatology
Sankt Gallen, Canton of St. Gallen, 9007
University of Zurich, Epidemiology, Biostatistics and Prevention Institute, Divison of Infectious Diseases
Zurich, Canton of Zurich, 8001
University of Zurich, University Hopsital, Divison of Rheumatology
Zurich, Canton of Zurich, 8091
About this study
Official title: A Prospective Cohort Study in 6 Swiss Rheumatology Centres and 4 Travel Clinics on the Immunogenicity and Safety of Tetanus and Hepatitis A Vaccine in Patients With Rheumatoid Arthritis, Axial Spondyloarthritis and Vasculitis and Healthy Controls
Backgound and relevance of the project:
Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of contracting infections. The increased risk can be attributed to the immunological disorder itself, as well as to the immunosuppressive treatment. Vaccination against many infections is recommended in this patient group. However, the immunogenicity of vaccines may be reduced and may also be influenced by the administered treatment. Potential reactivation of the underlying disease triggered by vaccination is another important concern.
Read more
From the patients' and public health perspectives, an important task of physicians is giving advice on vaccines. Completing this task is often difficult, because data on the immunogenicity and safety of vaccines in these patient groups are scarce, especially with regard to treatment with new immunosuppressive medications, such as biological agents. Lastly and importantly, due to new therapeutic options, health among AIIRD patients has considerably improved and an increasing number of patients undertake overseas travel activities requiring additional vaccinations. In this context, reliable advice with regard to vaccinations is almost impossible, because for most travel vaccinations the immunogenicity and safety profile is unknown.
Research addressing the immunogenicity and safety of vaccines in different autoimmune inflammatory diseases treated with different immunosuppressive medications is urgently needed to allow giving evidence based vaccine advice.
In this observational study the immunogenicity and safety of tetanus booster and hepatitis A vaccinations will be assessed in AIIRD patients. The immune response will be evaluated as a function of the underlying disease and the possible influence of commonly used immunosuppressive drugs on the immune response will be studied.
Rationale for studying tetanus booster and hepatitis A vaccine Tetanus vaccination is one of the most frequently recommended vaccinations, and the effect of a booster vaccination can be addressed. Hepatitis A vaccine is the most widely used travel vaccine. Despite their importance, only very limited data are available for tetanus and hepatitis A vaccine in this patient group. By focusing on these vaccines the study will lead the way to the evaluation of further vaccines.
The purpose of this study is to determine whether tetanus and hepatitis A vaccinations are as immunogenic and safe in AIIRD patients as in healthy controls.
Read the detailed description
The study will be placed in 6 rheumatology clinics in Switzerland and in 4 travel medicine clinics. Consecutive subjects with rheumatoid arthritis, spondylarthritis (ankylosing spondylitis), vasculitis (ANCA associated vasculitis and Behçet's disease) and healthy controls will be recruited.
- Conditions
- Arthritis, Rheumatoid, Spondylarthritis, Vasculitis
- Being tested
- Hepatitis A vaccine and tetanus vaccine
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis A vaccine and tetanus vaccineBiological
Also called Havrix 1440, Epaxal, Td-Pur, Boostrix
Hepatitis A and/or tetanus vaccination will be given to participants in all group on day 0. All monovalent active hepatitis A vaccinations and all vaccines containing tetanus toxoid available in Switzerland may be used in the study
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | If a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 319 healthy controls will be enrolled and will receive hepatitis A and/or tetanus vaccination Receives: Biological: Hepatitis A vaccine and tetanus vaccine | |
| Patients with rheumatoid arthritis | If a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with rheumatoid arthritis will be enrolled and will receive hepatitis A and/or tetanus vaccination. Receives: Biological: Hepatitis A vaccine and tetanus vaccine | |
| Patients with axial spondylarthritis | If a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with axial spondylarthritis will be enrolled and will receive hepatitis A and/or tetanus vaccination. Receives: Biological: Hepatitis A vaccine and tetanus vaccine | |
| Patients with vasculitis | If a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with vasculitis will be enrolled and will receive hepatitis A and/or tetanus vaccination. Receives: Biological: Hepatitis A vaccine and tetanus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of hepatitis A and tetanus vaccination in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls
comparison of the geometric mean antibody titre and percentage of seroprotected individuals after tetanus and hepatitis A vaccination between each disease group and healthy controls
Measured: Change from Baseline in geometric mean antibody titre and seroprotection at 4 weeks and at 12 weeks
Secondary outcomes (1)
Safety of tetanus and hepatitis A vaccines in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls
Number of patients with any worsening or reactivation of the rheumatic disease after vaccine administration
Number of participants with adverse vaccine reactions (local and systemic reactions) in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls
Measured: Activation of rheumatic disease will be assessed for 1 week after vaccine administration and at 4 and 12 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Swiss Tropical & Public Health Institute, University of Bern, University Hospital, Geneva, Cantonal Hospital of St. Gallen, Cantonal Hospital of Aarau, Switzerland
- Responsible party
- Sponsor
- Investigators
- Christoph Hatz, Professor, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947465
- Sponsor's protocol ID
- CS_2013_01
- Status last verified
- Feb 2016
- First submitted
- 22 Aug 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
van Assen S, Elkayam O, Agmon-Levin N, Cervera R, Doran MF, Dougados M, Emery P, Geborek P, Ioannidis JP, Jayne DR, Kallenberg CG, Muller-Ladner U, Shoenfeld Y, Stojanovich L, Valesini G, Wulffraat NM, Bijl M. Vaccination in adult patients with auto-immune inflammatory rheumatic diseases: a systematic literature review for the European League Against Rheumatism evidence-based recommendations for vaccination in adult patients with auto-immune inflammatory rheumatic diseases. Autoimmun Rev. 2011 Apr;10(6):341-52. doi: 10.1016/j.autrev.2010.12.003. Epub 2010 Dec 20.
PubMed 21182987Bijl M, Kallenberg CG, van Assen S. Vaccination of the immune-compromised patients with focus on patients with autoimmune-inflammatory diseases. Neth J Med. 2011 Jan;69(1):5-13.
PubMed 21325695Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002 Sep;46(9):2287-93. doi: 10.1002/art.10524.
PubMed 12355475Bernatsky S, Hudson M, Suissa S. Anti-rheumatic drug use and risk of serious infections in rheumatoid arthritis. Rheumatology (Oxford). 2007 Jul;46(7):1157-60. doi: 10.1093/rheumatology/kem076. Epub 2007 May 3.
PubMed 17478469Kotton CN. Vaccination and immunization against travel-related diseases in immunocompromised hosts. Expert Rev Vaccines. 2008 Jul;7(5):663-72. doi: 10.1586/14760584.7.5.663.
PubMed 18564020Rahier JF, Moutschen M, Van Gompel A, Van Ranst M, Louis E, Segaert S, Masson P, De Keyser F. Vaccinations in patients with immune-mediated inflammatory diseases. Rheumatology (Oxford). 2010 Oct;49(10):1815-27. doi: 10.1093/rheumatology/keq183. Epub 2010 Jun 29.
PubMed 20591834Steffen R, Kane MA, Shapiro CN, Billo N, Schoellhorn KJ, van Damme P. Epidemiology and prevention of hepatitis A in travelers. JAMA. 1994 Sep 21;272(11):885-9.
PubMed 8078167Agarwal N, Ollington K, Kaneshiro M, Frenck R, Melmed GY. Are immunosuppressive medications associated with decreased responses to routine immunizations? A systematic review. Vaccine. 2012 Feb 14;30(8):1413-24. doi: 10.1016/j.vaccine.2011.11.109. Epub 2011 Dec 21.
PubMed 22197580Buhler S, Jaeger VK, Adler S, Bannert B, Brummerhoff C, Ciurea A, Distler O, Franz J, Gabay C, Hagenbuch N, Herzog C, Hasler P, Kling K, Kyburz D, Muller R, Nissen MJ, Siegrist CA, Villiger PM, Walker UA, Hatz C. Safety and immunogenicity of tetanus/diphtheria vaccination in patients with rheumatic diseases-a prospective multi-centre cohort study. Rheumatology (Oxford). 2019 Sep 1;58(9):1585-1596. doi: 10.1093/rheumatology/kez045.
PubMed 30877773
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study in 6 Swiss Rheumatology Centres and 4 Travel Clinics on the Immunogenicity and Safety of Tetanus and Hepatitis A Vaccine in Patients With Rheumatoid Arthritis, Axial Spondyloarthritis and Vasculitis and Healthy Controls
- ClinicalTrials.gov ID
- NCT01947465
- Acronym / sponsor ID
- CS_2013_01
- Conditions
- Arthritis, Rheumatoid, Spondylarthritis, Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Basel, Swiss Tropical & Public Health Institute, University of Bern, University Hospital, Geneva, Cantonal Hospital of St. Gallen, Cantonal Hospital of Aarau, Switzerland
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Sep 2013 (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.
Backgound and relevance of the project:
Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of contracting infections. The increased risk can be attributed to the immunological disorder itself, as well as to the immunosuppressive treatment. Vaccination against many infections is recommended in this patient group. However, the immunogenicity of vaccines may be reduced and may also be influenced by the administered treatment. Potential reactivation of the underlying disease triggered by vaccination is another important concern.
From the patients' and public health perspectives, an important task of physicians is giving advice on vaccines. Completing this task is often difficult, because data on the immunogenicity and safety of vaccines in these patient groups are scarce, especially with regard to treatment with new immunosuppressive medications, such as biological agents. Lastly and importantly, due to new therapeutic options, health among AIIRD patients has considerably improved and an increasing number of patients undertake overseas travel activities requiring additional vaccinations. In this context, reliable advice with regard to vaccinations is almost impossible, because for most travel vaccinations the immunogenicity and safety profile is unknown.
Research addressing the immunogenicity and safety of vaccines in different autoimmune inflammatory diseases treated with different immunosuppressive medications is urgently needed to allow giving evidence based vaccine advice.
In this observational study the immunogenicity and safety of tetanus booster and hepatitis A vaccinations will be assessed in AIIRD patients. The immune response will be evaluated as a function of the underlying disease and the possible influence of commonly used immunosuppressive drugs on the immune response will be studied.
Rationale for studying tetanus booster and hepatitis A vaccine Tetanus vaccination is one of the most frequently recommended vaccinations, and the effect of a booster vaccination can be addressed. Hepatitis A vaccine is the most widely used travel vaccine. Despite their importance, only very limited data are available for tetanus and hepatitis A vaccine in this patient group. By focusing on these vaccines the study will lead the way to the evaluation of further vaccines.
The purpose of this study is to determine whether tetanus and hepatitis A vaccinations are as immunogenic and safe in AIIRD patients as in healthy controls.
Detailed description
The study will be placed in 6 rheumatology clinics in Switzerland and in 4 travel medicine clinics. Consecutive subjects with rheumatoid arthritis, spondylarthritis (ankylosing spondylitis), vasculitis (ANCA associated vasculitis and Behçet's disease) and healthy controls will be recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Biological: Hepatitis A vaccine and tetanus vaccineIf a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 319 healthy controls will be enrolled and will receive hepatitis A and/or tetanus vaccination |
| Patients with rheumatoid arthritis | – | Biological: Hepatitis A vaccine and tetanus vaccineIf a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with rheumatoid arthritis will be enrolled and will receive hepatitis A and/or tetanus vaccination. |
| Patients with axial spondylarthritis | – | Biological: Hepatitis A vaccine and tetanus vaccineIf a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with axial spondylarthritis will be enrolled and will receive hepatitis A and/or tetanus vaccination. |
| Patients with vasculitis | – | Biological: Hepatitis A vaccine and tetanus vaccineIf a vaccination is indicated according to the recommendations by the Swiss Federal Office of Public Health: 142 patients with vasculitis will be enrolled and will receive hepatitis A and/or tetanus vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be selected from patients with rheumatic diseases under treatment at 6 rheumatology outpatient clinics in Switzerland (University of Basel, University of Bern, University of Geneva, University of Zurich, Cantonal Hospital Aarau, Cantonal Hospital St. Gallen)
Key inclusion criteria (3 listed)
- Indication for hepatitis A and/or tetanus vaccination according to Swiss Federal Office of Public Health recommendations
- Male and female rheumatic patients with rheumatoid arthritis or axial spondyloarthritis (ankylosing spondylitis, axial psoriatic arthritis, axial undifferentiated spondyloarthritis, enteropahtic arthritis) or peripheral psoriatic arthritis or vasculitis (Behçet's disease or ANCA-associated vasculitis) or male and female healthy participants ≥ 18 years
- Signed Informed Consent after being informed
Key exclusion criteria (5 listed)
- Known hypersensitivity to a vaccine ingredient
- Estimated patient survival below 1 year
- Active malignant or active infectious disease
- Drug/alcohol abuse
- Insufficient understanding of local language
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 |
|---|---|---|
| Hepatitis A vaccine and tetanus vaccineAlso: Havrix 1440, Epaxal, Td-Pur, BoostrixHepatitis A and/or tetanus vaccination will be given to participants in all group on day 0. All monovalent active hepatitis A vaccinations and all vaccines containing tetanus toxoid available in Switzerland may be used in the study | Biological | Healthy controls, Patients with axial spondylarthritis, Patients with rheumatoid arthritis, Patients with vasculitis |
Primary outcome
Immunogenicity of hepatitis A and tetanus vaccination in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls
Time frame: Change from Baseline in geometric mean antibody titre and seroprotection at 4 weeks and at 12 weeks
comparison of the geometric mean antibody titre and percentage of seroprotected individuals after tetanus and hepatitis A vaccination between each disease group and healthy controls
1 secondary outcome
Safety of tetanus and hepatitis A vaccines in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls
Time frame: Activation of rheumatic disease will be assessed for 1 week after vaccine administration and at 4 and 12 weeks compared to baseline
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 Feb 2016.
- Background: PubMed 21182987van Assen S, Elkayam O, Agmon-Levin N, Cervera R, Doran MF, Dougados M, Emery P, Geborek P, Ioannidis JP, Jayne DR, Kallenberg CG, Muller-Ladner U, Shoenfeld Y, Stojanovich L, Valesini G, Wulffraat NM, Bijl M. Vaccination in adult patients with auto-immune inflammatory rheumatic diseases: a systematic literature review for the European League Against Rheumatism evidence-based recommendations for vaccination in adult patients with auto-immune inflammatory rheumatic diseases. Autoimmun Rev. 2011 Apr;10(6):341-52. doi: 10.1016/j.autrev.2010.12.003. Epub 2010 Dec 20.
- Background: PubMed 21325695Bijl M, Kallenberg CG, van Assen S. Vaccination of the immune-compromised patients with focus on patients with autoimmune-inflammatory diseases. Neth J Med. 2011 Jan;69(1):5-13.
- Background: PubMed 12355475Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002 Sep;46(9):2287-93. doi: 10.1002/art.10524.
- Background: PubMed 17478469Bernatsky S, Hudson M, Suissa S. Anti-rheumatic drug use and risk of serious infections in rheumatoid arthritis. Rheumatology (Oxford). 2007 Jul;46(7):1157-60. doi: 10.1093/rheumatology/kem076. Epub 2007 May 3.
- Background: PubMed 18564020Kotton CN. Vaccination and immunization against travel-related diseases in immunocompromised hosts. Expert Rev Vaccines. 2008 Jul;7(5):663-72. doi: 10.1586/14760584.7.5.663.
- Background: PubMed 20591834Rahier JF, Moutschen M, Van Gompel A, Van Ranst M, Louis E, Segaert S, Masson P, De Keyser F. Vaccinations in patients with immune-mediated inflammatory diseases. Rheumatology (Oxford). 2010 Oct;49(10):1815-27. doi: 10.1093/rheumatology/keq183. Epub 2010 Jun 29.
- Background: PubMed 8078167Steffen R, Kane MA, Shapiro CN, Billo N, Schoellhorn KJ, van Damme P. Epidemiology and prevention of hepatitis A in travelers. JAMA. 1994 Sep 21;272(11):885-9.
- Background: PubMed 22197580Agarwal N, Ollington K, Kaneshiro M, Frenck R, Melmed GY. Are immunosuppressive medications associated with decreased responses to routine immunizations? A systematic review. Vaccine. 2012 Feb 14;30(8):1413-24. doi: 10.1016/j.vaccine.2011.11.109. Epub 2011 Dec 21.
- Derived from this study: PubMed 30877773Buhler S, Jaeger VK, Adler S, Bannert B, Brummerhoff C, Ciurea A, Distler O, Franz J, Gabay C, Hagenbuch N, Herzog C, Hasler P, Kling K, Kyburz D, Muller R, Nissen MJ, Siegrist CA, Villiger PM, Walker UA, Hatz C. Safety and immunogenicity of tetanus/diphtheria vaccination in patients with rheumatic diseases-a prospective multi-centre cohort study. Rheumatology (Oxford). 2019 Sep 1;58(9):1585-1596. doi: 10.1093/rheumatology/kez045.
- Vaccination recommendations in immunocompromised persons, BelgiumLink provided by the sponsor.
- Vaccination recommendation for patients with rheumatic disease, Swiss society of rheumatologyLink provided by the sponsor.
Related trials for Arthritis, Rheumatoid
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Christoph Hatz, Professor principal investigator
University of Zurich
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Spondylarthritis, run by University of Zurich at 10 sites in Switzerland.
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 3 inclusion and 5 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland. 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.
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?
Immunogenicity of hepatitis A and tetanus vaccination in patients with rheumatoid arthritis, axial spondyloarthritis and vasculitis and in healthy controls (time frame: Change from Baseline in geometric mean antibody titre and seroprotection at 4 weeks and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947465, which also lists 9 linked publications.
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 Feb 2016.