Back to resultsClinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Raloxifene hydrochloride
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Raloxifene, Disease activity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Evista
Placebo
Arm Description
20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.
20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.
Outcomes
Primary Outcome Measures
Evaluation of DAS-28 criteria
Assessing of complications
Secondary Outcome Measures
DAS-28 criteria
Complications
EULAR criteria
HAQ-DI criteria
Assessing of Bone Marrow Density score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02982083
Brief Title
Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis
Official Title
Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Saeidi Shahri
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Raloxifene, Disease activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evista
Arm Type
Active Comparator
Arm Description
20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.
Intervention Type
Drug
Intervention Name(s)
Raloxifene hydrochloride
Other Intervention Name(s)
Evista
Intervention Description
20 patients consume raloxifene hydrochloride oral tablet daily for one year.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
20 patients consume placebo oral tablets daily for one year.
Primary Outcome Measure Information:
Title
Evaluation of DAS-28 criteria
Time Frame
3 months
Title
Assessing of complications
Time Frame
3 months
Secondary Outcome Measure Information:
Title
DAS-28 criteria
Time Frame
12 months
Title
Complications
Time Frame
12 months
Title
EULAR criteria
Time Frame
12 months
Title
HAQ-DI criteria
Time Frame
12 months
Title
Assessing of Bone Marrow Density score
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Sahebari, Professor
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis
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