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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02982083
Enrollment
34
Registered
2016-12-05
Start date
2015-09-30
Completion date
2020-09-30
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Raloxifene, Disease activity

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.

Interventions

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

DRUGPlacebo Oral Tablet

20 patients consume placebo oral tablets daily for one year.

Sponsors

Sara Saeidi Shahri
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evaluation of DAS-28 criteria3 months
Assessing of complications3 months

Secondary

MeasureTime frame
EULAR criteria12 months
DAS-28 criteria12 months
Assessing of Bone Marrow Density score12 months
HAQ-DI criteria12 months
Complications12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026