NCT02982083

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

4.3 years

First QC Date

December 1, 2016

Last Update Submit

December 1, 2021

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisRaloxifeneDisease activity

Outcome Measures

Primary Outcomes (2)

  • Evaluation of DAS-28 criteria

    3 months

  • Assessing of complications

    3 months

Secondary Outcomes (5)

  • DAS-28 criteria

    12 months

  • Complications

    12 months

  • EULAR criteria

    12 months

  • HAQ-DI criteria

    12 months

  • Assessing of Bone Marrow Density score

    12 months

Study Arms (2)

Evista

ACTIVE COMPARATOR

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

Drug: Raloxifene hydrochloride

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Raloxifene hydrochlorideDRUG

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

Also known as: Evista
Evista
Placebo Oral TabletDRUG

20 patients consume placebo oral tablets daily for one year.

Placebo

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with history of thrombotic events
  • Patients suffering from another rheumatic diseases simultaneously
  • Patients with sever symptoms of menopause
  • Patients with known psychological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35585813DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Maryam Sahebari, Professor

    Mashhad University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Student

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 5, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2019

Study Completion

September 1, 2020

Last Updated

December 16, 2021

Record last verified: 2021-12