Tuberculosis
Conditions
Interventions
All participants will be submitted to the same intervention. Each participant will be their own control. At visit one, blood samples will be obtained by direct venipuncture. To perform QuantiFERON (Ce
Drug
Other
E01.370.225.812.871.800
E01.370.225.812.453
Sponsors
Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Moderate to severe psoriasis; referred by dermatologists with indication of methotrexato use; aged over 18 years; living in the northeast region.
Exclusion criteria
Exclusion criteria: Abscence of BCG vaccination scar; pregnant women; women breastfeeding; previous use of immunosuppressant treatment; Topical use of medication for less than 6 months; lithium use; personal history; signs or symptoms of tuberculosis; chest X-ray compatible with lung disease; previous malignancy; positive serology for HIV, hepatitis B or C; liver enzyme elevation 3-fold above baseline; renal clearance less than 60 ml / min; lymphopenia below 1500 lymphocytes; platelet count below 100,000; or leukopenia below 3500 leukocytes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1- Change in the classification of tuberculosis screening tests determined by an increase of 5mm or more in the tuberculin test and by the change of category of positive/ negative/indeterminate Quantiferon compared before and after 3 months of methotrexate treatment;Outcome found 1- After treatment with methotrexate, there was a significant increase in the number of positive TT (p = 0.037). The changes in IGRA were not significant (p = 0.135);Expected Outcome 2- Significant change in serum levels of interferon gamma, alpha necrosis factor, interleukin-12, interleukin-17, interleukin-23, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and psoriasis severity, determined by serum quantification inflammatory drugs and for the calculation of PASI (psoriasis area and severity index) before and after 3 months of treatment with methotrexate;Outcome found 2- After treatment with methotrexate, there was a significant decrease in PASI (p< 0,001)and in CRP levels (p= 0.022)and not significant in ESR (p = 0.086). There was a significant increase in IFN-gamma levels (p = 0.005) and a non-significant increase in TNF alfa levels (p= 0.224).Interleukins 12, 17 and 23 naõ foram dosadas | — |
Secondary
| Measure | Time frame |
|---|---|
| Desfecho esperado 3-Loss of response to methotrexate determined by the reduction of PASI below 50% in the first 3 months or by reduction above 50% but which was not maintained over the 18-month follow-up period.;Outcome found 3- A CRP level before treatment of less than one and a PASI score above 68.5% (P <0.001) after 3 months of methotrexate treatment were associated with sustained response to treatment in the first 18 months of treatment. In those patients with sustained responses to treatment, there was a tendency towards higher initial levels of INF-gamma. The CRP level after treatment, the ESR, the TNF-alfa and the clinical characteristics were not associated with a sustained response to treatment. | — |
Countries
Brazil
Contacts
Public ContactVanessa Medeiros
Universidade Federal de Pernambuco
Outcome results
None listed