MEGRA
Methotrexate EGyptian Registry in Rheumatoid Arthritis
Project Managers
-
Prof. Abdelmonem Helal
Alexandria University
-
Prof. Sherif Refaat
Mansoura University
-
Prof. Hesham Hamoud
Al Azhar University
Objectives
-
General Objective
Concerning the initial treatment of rheumatoid arthritis in practice the project proposes to describe the Egyptian daily clinical practice reality
-
Specific Objectives
Primary objectives
in patients diagnosed with RA the time between the diagnosis of the disease and the initiation of therapy with MTX or Cs DMARDs, to assess the compliance with the EULAR 2013 and T2T recommendations of the initial phase of clinical management to assess the frequency of achievement of the 12 month target
-
Secondary objectives
-
Diagnosis and start of any DMARD:
-
To estimate the average time between visits .
-
To estimate the average time between the onset of symptoms and the first estimate the average dosage of treatment;
-
To estimate the frequency of prescription of MTX in the different routes of administration:
-
To estimate the frequency of therapies with DMARDs combination
-
To estimate the frequency of therapies with DMARDs in association; time; of conventional DMARDs.
-
To estimate the frequency of patients who start the drug in failure to achieve remission.
-
To estimate the frequency of prescription of different biological drugs after the failure of Cs DMARDs
-
To estimate the frequency of patients do not start the biological drug despite assessing the influence of different clinical settings on treatment modalities;
-
To evaluate the frequency of adverse events to traditional DMARDs.
Study design
Mixed cohort study, retrospective and prospective. Prospective Study Retrospective Study DMARD Bio Onset of Diagnosing MTX Symptoms Other DMARD Diagnosis onset MTX - Other symptoms
Recruitment centers
All rheumatology departments among the Egyptian universities, in addition to some of the potential rheumatology private clinics will have a unique username and password to login and add his last recruitment patients: Consecutive patients. Recruitment 18 months. Minimum 12 month follow-up (first patient assessed: 30 months) study.
Outcome variables
Analysis plan
-
Analysis of the primary outcome
Primary outcomes will be estimated as a mean therapeutic delay and as a probability (risk) of achievement of the target / or adherence to recommendations and 95% confidence intervals
-
Analysis of secondary outcomes
Secondary outcomes will be estimated in a similar way to primary ones
-
Explorative analysis
The influence of demographic, clinical (serological), therapeutic factors (association with glucocorticoids), organizational (setting), pathway (time to referral, to diagnosis ,to treatment) on the variables of longitudinal outcome (target achievement, treatment survival, adverse events, biological switch) will be explored using regression models appropriate to type of outcome variable