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

NCT02982083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-12-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Raloxifene hydrochloride

20 patients consume raloxifene hydrochloride oral tablet daily for one year.

DRUG

Placebo Oral Tablet

20 patients consume placebo oral tablets daily for one year.

Sponsors & Collaborators

  • Sara Saeidi Shahri

    lead OTHER

Principal Investigators

  • Maryam Sahebari, Professor · Mashhad University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-12-31
Completion
2020-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02982083 on ClinicalTrials.gov