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VACcination In Methotrexate Treated Rheumatoid Arthritis Patients (VACIMRA)

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ClinicalTrials.gov Identifier: NCT01942174
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : August 3, 2020
Sponsor:
Collaborators:
Hôpital Cochin
Pfizer
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Prevenar 13 Biological: Pneumo23 / Pneumovax Drug: Methotrexate - Immediate Drug: Methotrexate - Delay Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis
Actual Study Start Date : September 27, 2013
Actual Primary Completion Date : August 2018
Actual Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Immediate group

For these patients, the methotrexate treatment is initiated in the same time that the antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination.

Interventions : biological/vaccine and drug

Biological: Prevenar 13
Vaccination at the beginning of the study (day 0)
Other Name: Antipneumococcal vaccination

Biological: Pneumo23 / Pneumovax
Vaccination 2 months later the beginning of the study NB : Vaccine Pneumo23 has been replaced by equivalent vaccine Pneumovax in September 2017 because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company
Other Name: Antipneumococcal vaccination

Drug: Methotrexate - Immediate
concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13
Other Name: conventional methotrexate treatment

Experimental: period group

Methotrexate treatment is initiated 1 month later the first antipneumococcal vaccination by Prevenar13.

A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination

Interventions : biological/vaccine and drug

Biological: Prevenar 13
Vaccination at the beginning of the study (day 0)
Other Name: Antipneumococcal vaccination

Biological: Pneumo23 / Pneumovax
Vaccination 2 months later the beginning of the study NB : Vaccine Pneumo23 has been replaced by equivalent vaccine Pneumovax in September 2017 because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company
Other Name: Antipneumococcal vaccination

Drug: Methotrexate - Delay
For "period group", methotrexate is Initiated & month after the antipneumococcal vaccination by prevenar 13
Other Name: Experimental methotrexate treatment




Primary Outcome Measures :
  1. rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis. [ Time Frame: 1 month ]

    Patient who begins a treatement by methotrexate either in the same time, either 1 month later.

    An answer will be considered as positive if the patient answers in at least 3 on 5 of interest serotypes.



Secondary Outcome Measures :
  1. Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13) [ Time Frame: 1 month ]
  2. Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13) [ Time Frame: 1 month ]
  3. Number of patients who will know a fully immunological answer (13 serotypes of vaccine) after a antipneumococcal revaccination with Pneumo 23. [ Time Frame: 3, 6 and 12 months ]
  4. Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination [ Time Frame: up to 12 months ]
  5. Frequency of occurence of disease spurts from the first vaccination until the end of the study [ Time Frame: Up to 12 months ]
  6. occurence of the pneumococcal disease from the first vaccination to the end of the study. [ Time Frame: 1, 6, 7 and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 yeas old) suffers from rheumatoid arthritis considering ACR/EULAR 2010 criteria
  • Rheumatoid arthritis considering 3,2<DAS<5,1
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942174


Locations
Show Show 21 study locations
Sponsors and Collaborators
University Hospital, Montpellier
Hôpital Cochin
Pfizer
Investigators
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Principal Investigator: Jacques MOREL, PU-PH University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01942174    
Other Study ID Numbers: 9144
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Keywords provided by University Hospital, Montpellier:
Antipneumococcal vaccination
Methotrexate treatment
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors