Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, Raloxifene, Disease activity
Brief summary
The investigators select 40 postmenopausal women suffering from RA with 2.5\<DAS28\<5.5 referring to rheumatology clinics of Mashhad university of medical sciences and randomly divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are administered double blind. In the beginning, total bone mineral density (BMD) assessment is carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3 months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At the end of month 3, disease activity and probable complications are evaluated and compared in 2 groups. Classic regimen should be started for every patient who doesn't enter remission phase in first 3 months. In 4th month, DMARD regimen is administered and then patients are visited every 2 months. Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another total BMD test is carried out and then data are analyzed including changes in BMD, DAS28, EULAR response criteria and HAQ-DI score.
Interventions
20 patients consume raloxifene hydrochloride oral tablet daily for one year.
20 patients consume placebo oral tablets daily for one year.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients are postmenopausal women. * Patients should fit at least 4 criteria of ACR-1987 criteria for rheumatoid arthritis. * Patients should be in range of 2.5 \<DAS28-ESR \<5.5
Exclusion criteria
* Patients with history of thrombotic events * Patients suffering from another rheumatic diseases simultaneously * Patients with sever symptoms of menopause * Patients with known psychological diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of DAS-28 criteria | 3 months |
| Assessing of complications | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| EULAR criteria | 12 months |
| DAS-28 criteria | 12 months |
| Assessing of Bone Marrow Density score | 12 months |
| HAQ-DI criteria | 12 months |
| Complications | 12 months |