Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Raloxifene hydrochloride
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evista<br>20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year. | Drug: Raloxifene hydrochloride<br>* 20 patients consume raloxifene hydrochloride oral tablet daily for one year.<br>* Other names: Evista;|
| Placebo Comparator: Placebo<br>20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year. | Drug: Placebo Oral Tablet<br>* 20 patients consume placebo oral tablets daily for one year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of DAS-28 criteria |  | 3 months | 
| Assessing of complications |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS-28 criteria |  | 12 months | 
| Complications |  | 12 months | 
| EULAR criteria |  | 12 months | 
| HAQ-DI criteria |  | 12 months | 
| Assessing of Bone Marrow Density score |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Raloxifene, Disease activity