Rheumatoid arthritis. Rheumatoid arthritis with rheumatoid factor
Conditions
Interventions
Intervention 1: Intervention group: The intervention group includes patients with rheumatoid arthritis who will continue their routine therapy including methotrexate (7.5-25 mg/weekly), prednisolone (
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: Definite diagnosis of rheumatoid arthritis according to the American College of Rheumatology criteria and DAS28 score Patients in the early phase of diagnosis (before major therapeutic changes) Receiving stable doses of standard triple therapy including methotrexate, prednisolone, and hydroxychloroquine No use of vitamin supplements or antioxidant compounds within the last two months Willingness and ability to participate in the study and providing written informed consent
Exclusion criteria
Exclusion criteria: Presence of other autoimmune diseases, uncontrolled hypertension, diabetes, heart failure, chronic kidney disease, hepatic or endocrine disorders Pregnancy or lactation Use of sedative drugs, oral contraceptives, antioxidant supplements, or omega-3 during the past month Smoking or alcohol consumption Body mass index > 30 kg/m2 Known hypersensitivity to melatonin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum PD-1 level. Timepoint: At baseline and 12 weeks after intervention. Method of measurement: 5 milliliter of fasting venous blood will drone and after serum separation, serum level of PD-1 using a commercial ELISA kit per manufacturer’s instructions will be measured. All assays performed in the same laboratory and preferably with a single lot. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical signs and disease activity. Timepoint: At baseline and 12 weeks after intervention. Method of measurement: DAS28 score will be calculated based on the count of 28 tender and swollen joints, erythrocyte sedimentation rate or C-reactive protein, and patient’s global assessment using a visual analogue scale. All assessments will be performed by a rheumatologist. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadreza Nakhjawani
Tabriz University of Medical Sciences
Outcome results
None listed