Chikungunya Fever
Conditions
Interventions
40 patients will be enrolled and randomized 1:1 to methotrexate (20 patients) 20 mg weekly (4 tablets of 2.5 mg each concealed in capsules on two consecutive days) along with folic acid 5 mg weekly an
E02.319
Sponsors
José Kennedy Amaral Pereira
Instituto de Medicina Diagnóstica do Cariri
Eligibility
Age
16 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria; Men and women; from 18 to 90 years old; Able to provide informed consent; Laboratory confirmation of chikungunya virus infection (IgG or IgM serology or RT-PCR); New inflammatory arthritis that affects at least one joint; For women of childbearing age; a negative pregnancy test before starting treatment; Note Due to the risk to the child during MTX therapy, in addition to the initial pregnancy test being negative; women must agree to use contraceptive methods during treatment; As well as not intending to become pregnant during treatment
Exclusion criteria
Exclusion criteria: Exclusion criteria; Pre-existing history of inflammatory or non-inflammatory arthritis, or If there is a pre-existing history of arthritis, there must be new inflammatory arthritis affecting at least one joint; Contraindication to MTX therapy; including history of MTX hypersensitivity; pre-existing liver disease, abnormal liver function tests (greater than 2 times normal), significant alcohol consumption, stomatitis, haematological abnormalities, pulmonary fibrosis, renal failure (serum creatinine > 1.5); current or past history of chronic infection; or treatment with any other immunomodulatory drug; Pregnancy or refusal to use contraceptive methods during the treatment phase.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess clinical improvement using the DAS28-ESR disease activity assessment method, based on the decrease in the DAS28-ESR score pre and post-intervention;Assess clinical improvement using the total tender joint count and swollen joint count method, based on the reduction in the number of painful and swollen joints pre and post-intervention;Assess clinical improvement using the HAQ-DI questionnaire method and the visual analogue pain scale, based on the decrease in the HAQ-DI score and the visual analogue pain scale score pre and post-intervention;Assess clinical improvement through the global assessment method of the disease by the patient and the doctor, based on the decrease in their pre- and post-intervention scores | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a greater reduction in the count of tender joints and swollen joints in the methotrexate treatment group compared to the placebo group at 8 weeks of therapy;It is expected to find a greater number of individuals in remission, using the DAS28-ESR disease activity assessment method, based on the definition of remission when DAS28-ESR =2.6 in the methotrexate treatment group compared to the placebo in 8 weeks of therapy;It is expected to find a greater decrease of the HAQ-DI score and pain visual analogue scale score in the methotrexate treatment group compared to the placebo group at 8 weeks of therapy;It is expect to find a greater decrease in patient and physician global assessment scores in the methotrexate treatment group compared to the placebo group at 8 weeks of therapy | — |
Countries
Brazil
Contacts
Public ContactJosé Kennedy Pereira
Instituto de Medicina Diagnóstica do Cariri
Outcome results
None listed