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

NCT ID: NCT02982083

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-09-30

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid arthritis Raloxifene Disease activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Evista

20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.

Group Type ACTIVE_COMPARATOR

Raloxifene hydrochloride

Intervention Type DRUG

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

Placebo

20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

20 patients consume placebo oral tablets daily for one year.

Interventions

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Raloxifene hydrochloride

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

Intervention Type DRUG

Placebo Oral Tablet

20 patients consume placebo oral tablets daily for one year.

Intervention Type DRUG

Other Intervention Names

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Evista

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sara Saeidi Shahri

OTHER

Sponsor Role lead

Responsible Party

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Sara Saeidi Shahri

Medical Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Maryam Sahebari, Professor

Role: STUDY_DIRECTOR

Mashhad University of Medical Sciences

References

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Sahebari M, Sarafraz Yazdi M, Mehrnaz Aghili S, Esmaily H, Saeidi S, Salari M. Efficacy of Raloxifene as Add-on Therapy on Disease Activity of Postmenopausal Women with Rheumatoid Arthritis: A Double-blind, Randomized, Placebo-controlled Clinical Trial. Curr Rheumatol Rev. 2023;19(1):93-101. doi: 10.2174/1573397118666220518114415.

Reference Type DERIVED
PMID: 35585813 (View on PubMed)

Other Identifiers

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931755

Identifier Type: -

Identifier Source: org_study_id