Skip to main content
OpenTrials
Completed

NCT Number: NCT02982083

Clinical Trial on the Efficacy of Raloxifene on Disease Activity in 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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raloxifene hydrochloride

Drug

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

Other names: Evista

Placebo oral tablet

Drug

20 patients consume placebo oral tablets daily for one year.

Primary outcomes

  1. Evaluation of DAS-28 criteria

    Time frame: 3 months

  2. Assessing of complications

    Time frame: 3 months

Secondary outcomes

  1. DAS-28 criteria

    Time frame: 12 months

  2. Complications

    Time frame: 12 months

  3. EULAR criteria

    Time frame: 12 months

  4. HAQ-DI criteria

    Time frame: 12 months

  5. Assessing of Bone Marrow Density score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Sara Saeidi Shahri

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Dec 5, 2016
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.