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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982083
• Other study ID #: 931755
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2020

Study information

• Verified date: December 2021
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Raloxifene hydrochloride
20 patients consume raloxifene hydrochloride oral tablet daily for one year.
• Placebo Oral Tablet
20 patients consume placebo oral tablets daily for one year.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sara Saeidi Shahri

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of DAS-28 criteria		3 months
Primary	Assessing of complications		3 months
Secondary	DAS-28 criteria		12 months
Secondary	Complications		12 months
Secondary	EULAR criteria		12 months
Secondary	HAQ-DI criteria		12 months
Secondary	Assessing of Bone Marrow Density score		12 months