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Rheumatoid ArthritisPhase 3VACIMRANCT01942174

VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

A Phase 3 study testing Prevenar 13, Pneumo23 / Pneumovax and Methotrexate - Immediate in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Prevenar 13, Pneumo23 / Pneumovax and Methotrexate - Immediate
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
21 sitesin 2 countries
Study dates
27 Sep 2013to 10 Jul 2019
Phase
Phase 3
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

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

France20 sites

  • CHU Nord

    Amiens, 80054

  • CHU Pellegrin

    Bordeaux, 33000

  • CHU La Cavale Blanche

    Brest, 29609

  • CHU Montpied

    Clermont-Ferrand, 63003

  • CHU Bicetre

    Le Kremlin-Bicêtre, 94275

  • CH Du Mans

    Le Mans, 72000

  • CHU Dupuytren

    Limoges, 87042

  • CHU La Conception

    Marseille, 13005

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • CHU de Nice - Hôpital L'Archet 1

    Nice, 06202

  • CHU Carémeau

    Nîmes, 30029

  • CHU Orléans - Hôpital La Source

    Orléans, 45000

  • CHU Saint Antoine

    Paris, 75012

  • CHU La Pitié Salpétrière

    Paris, 75013

  • CHU de Rennes

    Rennes, 35056

  • CHU Bois Guillaume

    Rouen, 76031

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne, 42055

  • CHU Hautepierre

    Strasbourg, 67098

  • CHU Purpan

    Toulouse, 31059

  • CHU Trousseau

    Tours, 37044

Other trials in France

Monaco1 site

  • CHPG Monaco - Hôpital Prince Grace de Monaco

    Monaco, 98000

Other trials in Monaco

About this study

Official title: Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis

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.

Read the 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.

Being tested
Prevenar 13, Pneumo23 / Pneumovax, Methotrexate - Immediate, Methotrexate - Delay
Keywords
Antipneumococcal vaccination, Methotrexate treatment
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prevenar 13Biological

    Also called Antipneumococcal vaccination

    Vaccination at the beginning of the study (day 0)

  • Pneumo23 / PneumovaxBiological

    Also called Antipneumococcal vaccination

    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

  • Methotrexate - ImmediateDrug

    Also called conventional methotrexate treatment

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

  • Methotrexate - DelayDrug

    Also called Experimental methotrexate treatment

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

Study groups in NCT01942174
Study groupRoleWhat they receive
Immediate groupOtherFor 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
Receives: Biological: Prevenar 13; Biological: Pneumo23 / Pneumovax; Drug: Methotrexate - Immediate
period groupExperimentalMethotrexate 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
Receives: Biological: Prevenar 13; Biological: Pneumo23 / Pneumovax; Drug: Methotrexate - Delay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis.

    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.

    Measured: 1 month

Secondary outcomes (6)

  1. Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13)

    Measured: 1 month

  2. Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13)

    Measured: 1 month

  3. Number of patients who will know a fully immunological answer (13 serotypes of vaccine) after a antipneumococcal revaccination with Pneumo 23.

    Measured: 3, 6 and 12 months

  4. Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination

    Measured: up to 12 months

  5. Frequency of occurence of disease spurts from the first vaccination until the end of the study

    Measured: Up to 12 months

  6. occurence of the pneumococcal disease from the first vaccination to the end of the study.

    Measured: 1, 6, 7 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2013 (estimated)
  2. Study start27 Sep 2013
  3. Primary completionAug 2018
  4. Study completion10 Jul 2019

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01942174
Sponsor's protocol ID
9144
Acronym
VACIMRA
Status last verified
Jul 2020
First submitted
10 Sep 2013
Last updated
3 Aug 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Than T, Mouterde G, Immediato Daien C, Lukas C, Remy-Moulard A, Gaujoux Viala C, Pissarra J, Huguet H, Picot MC, Morel J. One-month delay in MTX initiation on RA outcomes: 1-year ancillary analysis of the VACIMRA trial. Rheumatology (Oxford). 2026 Jun 3;65(6):keag270. doi: 10.1093/rheumatology/keag270.

    PubMed 42172618

  • Morel J, Dernis E, Roux C, Richez C, Brocq O, Fautrel B, Salliot C, Vittecoq O, Mariette X, Liote F, Lassoued S, Gaujoux-Viala C, Constantin A, Soubrier M, Devauchelle-Pensec V, Goeb V, Gottenberg JE, Marotte H, Moulard AR, Daien C, Mouterde G, Lukas C, Pissarra J, Huguet H, Launay O, Galtier F, Picot MC; I-REIVAC; CRI-IMIDIATE French Clinical Research Networks. Effect of a 1-month methotrexate delay on pneumococcal vaccine immunogenicity and disease control in patients with early rheumatoid arthritis (VACIMRA): an open-label randomised trial. Lancet Rheumatol. 2025 Oct;7(10):e675-e686. doi: 10.1016/S2665-9913(25)00071-2. Epub 2025 Jul 29.

    PubMed 40749694

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prevenar 13, Pneumo23 / Pneumovax and Methotrexate - Immediate in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 21 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 6 inclusion and 15 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France, Monaco. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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). 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 NCT01942174, which also lists 2 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 3 Aug 2020.

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