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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo Oral Tablet; Drug: Raloxifene hydrochloride

• Registration Number: NCT02982083
• Lead Sponsor: Sara Saeidi Shahri

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-05
• Primary Completion: 2019-12
• Study Completion: 2020-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.
Evista	Raloxifene hydrochloride	20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.

Primary Outcome Measures

Name	Time	Method
Evaluation of DAS-28 criteria	3 months
Assessing of complications	3 months

Secondary Outcome Measures

Name	Time	Method
Complications	12 months
Assessing of Bone Marrow Density score	12 months
DAS-28 criteria	12 months
EULAR criteria	12 months
HAQ-DI criteria	12 months