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VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

NCT01942174 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2020-08-03

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Prevenar 13

Vaccination at the beginning of the study (day 0)

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Vaccination 2 months later the beginning of the study NB : Vaccine Pneumo23 has been replaced by equivalent vaccine Pneumovax in September 2017 because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company

DRUG

Methotrexate - Immediate

concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13

DRUG

Methotrexate - Delay

For "period group", methotrexate is Initiated \& month after the antipneumococcal vaccination by prevenar 13

Sponsors & Collaborators

  • Hôpital Cochin

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Jacques MOREL, PU-PH · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-27
Primary Completion
2018-08-31
Completion
2019-07-10

Countries

  • France
  • Monaco

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01942174 on ClinicalTrials.gov