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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02982083
Recruitment Status : Not yet recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):
Sara Saeidi Shahri, Mashhad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Raloxifene hydrochloride Drug: Placebo Oral Tablet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Evista
20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.
Drug: Raloxifene hydrochloride
20 patients consume raloxifene hydrochloride oral tablet daily for one year.
Other Name: Evista

Placebo Comparator: Placebo
20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.
Drug: Placebo Oral Tablet
20 patients consume placebo oral tablets daily for one year.

Primary Outcome Measures :
  1. Evaluation of DAS-28 criteria [ Time Frame: 3 months ]
  2. Assessing of complications [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02982083

Contact: Sara Saeidi Shahri 00989156846143

Sponsors and Collaborators
Sara Saeidi Shahri

Responsible Party: Sara Saeidi Shahri, Medical Student, Mashhad University of Medical Sciences Identifier: NCT02982083     History of Changes
Other Study ID Numbers: 931755
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016

Keywords provided by Sara Saeidi Shahri, Mashhad University of Medical Sciences:
Rheumatoid arthritis
Disease activity

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Raloxifene Hydrochloride
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents