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

December 1, 2021 updated by: Sara Saeidi Shahri

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara Saeidi Shahri

Investigators

  • Study Director: Maryam Sahebari, Professor, Mashhad University Of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 931755

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Raloxifene hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe