Mitra Project
Methotrexate in Italian patients wiTh Rheumatoid Arthritis

Progetto Mitra

Project Leaders

Roberto Caporali - UC Reumatologia, Università di Pavia, IRCCS Policlinico S.Matteo, Pavia,
Florenzo Iannone - UO Reumatologia, Università degli Studi di Bari,
Elisa Gremese - Divisione Reumatologia Università Cattolica del Sacro Cuore, Roma,


Recent EULAR guidelines underline the importance of a diagnosis and early treatment of rheumatoid arthritis, and have individuated Methotrexate (MTX) as the anchor drug. In the therapeutic algorithm, monotherapy with MTX has not been selected as the only advisable drug, but is recommended for initial therapy in combination with conventional DMARDs. The same guidelines (and treat-to-target recommendations) advise increasing therapy in the event of a failure to respond, and progressing to treatment with biologics in combination with MTX when the target is not reached (remission or low disease activity).

The innovative feature of the project

Despite the numerous records available at an international level, the data related to the time between the onset of symptoms, diagnosis and initiation of therapy with MTX are not organic and consistent. Moreover, the data on MTX therapy (initial dose, method of administration, folate supplementation) are very few and not easy to interpret. Finally, there is a total lack of data on the application of treat-to-target in daily clinical practice, particularly the speed with which the initial therapy is varied in the event of failure to reach the target, and the starting times of biologic drugs for patients who do not respond to MTX or do not reach the target.


General objective

  • The project aims to describe the situation in Italy regarding the initial treatment of rheumatoid arthritis in daily clinical practice.


Primary objectives

In patients with a diagnosis of RA:

  • estimate the time period between disease onset and initiation of therapy with MTX;
  • assess adherence to the EULAR 2013 and T2T recommendations of the initial phase of clinical management;
  • assess the frequency of reaching the target at 12 months.

Secondary objectives

  • estimate the average time between diagnosis and the start of any DMARD;
  • estimate the average time between the onset of symptoms and the first visit to a rheumatologist;
  • estimate the average dosage of MTX at the start of treatment;
  • estimate the frequency of prescription of MTX in the different routes of administration;
  • estimate the frequency of therapy with DMARDs in combination;
  • estimate the frequency of treatment with glucocorticoids in combination;
  • estimate the frequency of patients starting a biologic drug over time;
  • estimate the frequency of prescription of different biologic drugs after failure of conventional DMARDs;
  • estimate the frequency of patients who do not start the biologic drug despite failure to reach the target;
  • assess the influence of different clinical settings on treatment mode;
  • assess the frequency of adverse events to traditional DMARDs.