VACcination In Methotrexate Treated Rheumatoid Arthritis Patients
NCT01942174
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- Adult (>18 yeas old) suffers from rheumatoid arthritis considering ACR/EULAR 2010 criteria
- Rheumatoid arthritis considering 3,2 - Patient did not treat by long term treatment or has stopped a treatment by
sulfasalazine, hydroxychloroquine or methotrexate for at least 3 months - Patient has never treated by biotherapy - Patient has never vaccinated against pneumococcal - Patient has signed study consent form
- Patient has ever treated by leflunomide or has treated previously by leflunomide (last
3 months)
- Patient is currently treated by methotrexate or has treated previously by methotrexate
(last 3 months)
- Contraindication to methotrexate: renal insuffisance, alcoolic, chronic hepatisis,
infectious condition, AIDS, hematological failure (cytopeny), pregnancy, obesity,
diabet, respiratory disease, gastric ulcer
- Contraindication to corticotherapy
- Pregnancy or pregancy wish
- Nursing
- Absence of oral contraception for women of childbearing age
- Patient of age protected by law et deprived of liberty
- Subject who refuses to be vaccinated against pneumococcis agent
- Previous history of vaccination allergy (anaphylactic shok, Quincke oedema...)
- Gluten hypersensivity or intolerance
- Other vaccination during the last month before inclusion
- Ig perfusion during the last 3 months period before the study inclusion or during the
study duration
- Patient currently treated by anticoagulant or has not been stopped for at least 48h
before the study inclusion or hemostasis failure which is contraindicated with
muscular injection
- Participation with an other clinical trial
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Descriptive Information | ||||
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Brief Title ICMJE | VACcination In Methotrexate Treated Rheumatoid Arthritis Patients | |||
Official Title ICMJE | Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis | |||
Brief Summary | To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and who begin a treatement by methotrexate either in the same time, either 1 month later. | |||
Detailed Description | Patients suffering from rheumatoid polyarthritis have an increased risk to develop an infection compared to general population, with a more important mortality risk because pneumococcus is considered as one of the major pathogenic agents. Antipneumcoccal vaccination is recommended to patients suffering from chronic inflammatory rheumatism treated with immunosuppressants. Methotrexate is a long term treatment used in first intention for rheumatoid polyarthritis. A recent study shows a decrease of efficacity of antipneumoccal vaccination for patients suffering from rheumatoid polyarthritis treated by methotrexate. The tested hypothesis will be the presence of better vaccinal protection for patients suffered from rheumatoid polyarthritis after 1 month between antipneumococcal vaccination and the initiation of methotrexate. The objective is to compare immunologic response for antipneumococcal vaccination between patients who are vaccinated in the same time of initiation of methotrexate and patients who are vaccinated 1 month before the beginning of the treatment. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Rheumatoid Arthritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 276 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 10, 2019 | |||
Actual Primary Completion Date | August 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France, Monaco | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01942174 | |||
Other Study ID Numbers ICMJE | 9144 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University Hospital, Montpellier | |||
Study Sponsor ICMJE | University Hospital, Montpellier | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University Hospital, Montpellier | |||
Verification Date | July 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |