Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT02982083|
Recruitment Status : Unknown
Verified December 2016 by Sara Saeidi Shahri, Mashhad University of Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Raloxifene hydrochloride Drug: Placebo Oral Tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2017|
Active Comparator: Evista
20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.
Drug: Raloxifene hydrochloride
20 patients consume raloxifene hydrochloride oral tablet daily for one year.
Other Name: Evista
Placebo Comparator: Placebo
20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.
Drug: Placebo Oral Tablet
20 patients consume placebo oral tablets daily for one year.
- Evaluation of DAS-28 criteria [ Time Frame: 3 months ]
- Assessing of complications [ Time Frame: 3 months ]
- DAS-28 criteria [ Time Frame: 12 months ]
- Complications [ Time Frame: 12 months ]
- EULAR criteria [ Time Frame: 12 months ]
- HAQ-DI criteria [ Time Frame: 12 months ]
- Assessing of Bone Marrow Density score [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982083
|Contact: Sara Saeidi Shahri||00989156846143||Frisetareh@yahoo.com|