Rheumatoid ArthritisNCT02982083
Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis
A study testing Raloxifene hydrochloride in people with Rheumatoid Arthritis, run by Sara Saeidi Shahri.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Raloxifene hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with history of thrombotic events
- Patients suffering from another rheumatic diseases simultaneously
- Patients with sever symptoms of menopause
- Patients with known psychological diseases
About this study
Official title: Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Raloxifene hydrochloride, Placebo Oral Tablet
- Keywords
- Rheumatoid arthritis, Raloxifene, Disease activity
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raloxifene hydrochlorideDrug
Also called Evista
20 patients consume raloxifene hydrochloride oral tablet daily for one year.
Placebo Oral TabletDrug
20 patients consume placebo oral tablets daily for one year.
| Study group | Role | What they receive |
|---|---|---|
| Evista | Active comparator | 20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year. Receives: Drug: Raloxifene hydrochloride |
| Placebo | Placebo comparator | 20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of DAS-28 criteria
Measured: 3 months
Assessing of complications
Measured: 3 months
Secondary outcomes (5)
DAS-28 criteria
Measured: 12 months
Complications
Measured: 12 months
EULAR criteria
Measured: 12 months
HAQ-DI criteria
Measured: 12 months
Assessing of Bone Marrow Density score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Saeidi Shahri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Saeidi Shahri, Mashhad University of Medical Sciences
- Investigators
- Maryam Sahebari, Professor, Study director, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982083
- Sponsor's protocol ID
- 931755
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2016
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35585813
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02982083
- Acronym / sponsor ID
- 931755
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Raloxifene, Disease activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sara Saeidi ShahriUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evista | Active comparator | Drug: Raloxifene hydrochloride20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year. |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients with history of thrombotic events
- Patients suffering from another rheumatic diseases simultaneously
- Patients with sever symptoms of menopause
- Patients with known psychological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raloxifene hydrochlorideAlso: Evista20 patients consume raloxifene hydrochloride oral tablet daily for one year. | Drug | Evista |
| Placebo Oral Tablet20 patients consume placebo oral tablets daily for one year. | Drug | Placebo |
Primary outcome
Evaluation of DAS-28 criteria
Time frame: 3 months
Assessing of complications
Time frame: 3 months
5 secondary outcomes
DAS-28 criteria
Time frame: 12 months
Complications
Time frame: 12 months
EULAR criteria
Time frame: 12 months
HAQ-DI criteria
Time frame: 12 months
Assessing of Bone Marrow Density score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 35585813Sahebari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Sahebari, Professor study director
Mashhad University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Raloxifene hydrochloride in people with Rheumatoid Arthritis, run by Sara Saeidi Shahri.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of DAS-28 criteria (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.