Rheumatoid Arthritis
Conditions
Brief summary
Rheumatoid arthritis (RA) is a long-term inflammatory condition that leads to gradual damage of joints lined by synovial membranes, along with various potential effects outside of the joints. While RA can affect any joint, it typically involves the metacarpophalangeal, proximal interphalangeal, and metatarsophalangeal joints, as well as the wrists and knees. Symptoms related to the joints and surrounding tissues include swelling, tenderness upon touch, morning stiffness, and significant difficulty moving the affected joints
Interventions
DRUGMethotrexate
Methotrexate (MTX) is a chemotherapy agent and immune-system suppressant. It is used to treat cancer, autoimmune diseases, and ectopic pregnancies. Types of cancers it is used for including breast cancer, leukemia, lung cancer, lymphoma, gestational trophoblastic disease, and osteosarcoma. Methotrexate is also used to treat rheumatoid arthritis and other inflammatory conditions.
DRUGPentoxifylline
Pentoxifylline (also known as oxpentifylline) is a methylxanthine derivative with strong hemorrheologic effects. In the United States, it is primarily used to treat intermittent claudication. Studies in both humans and animals have demonstrated that pentoxifylline therapy induces various physiological changes at the cellular level
Sponsors
Prof. Sahar Kamal Hegazy, Professor of Clinical Pharmacy, Faculty of Pharmacy - Tanta University
Dr. Mustafa Adel Mustafa Elmenawy Lecturer of Rheumatology and Rehabilitation, Faculty of Medicine - El-Azhar University - Damietta
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) \[9\] i.e., 28 joints disease activity score (DAS 28) \>2.6. * Patients receiving the conventional DMARDs. * Both sexes. * Age range between 18and 70 years old
Exclusion criteria
* Patients with retinal or cerebral hemorrhage. * Patients with renal and hepatic dysfunction. * Patients with hypersensitivity to study medications. * Pregnant and lactating females. * Patients receiving biological or synthetic DMARDs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Disease Activity Score (DAS28) | 3 months | Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) according to the following formula: DAS28-CRP = \[0.56\*√ (tender joint count) + 0.28\*√ (swollen joint count) + 0.36\*ln (CRP+1)\] \*1.10 + 1.15\] will be done where sever disease activity ≥ 5.1, moderate disease activity from 3.2 to 5.1, mild disease activity from 2.6 to 3.2, and remission \<2.6. |
Countries
Egypt
Outcome results
None listed