Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis

ConditionRheumatoid Arthritis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with retinal or cerebral hemorrhage.

Patients with renal and hepatic dysfunction.

Patients with hypersensitivity to study medications.

Pregnant and lactating females.

Trial design

Design model

Parallel

Treatments tested in this trial

Methotrexate
Drug
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.
Pentoxifylline
Drug
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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Control groupActive comparator 1 intervention

Group B: Pentoxifylline groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

change in Disease Activity Score (DAS28)

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.

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Dr. Mustafa Adel Mustafa Elmenawy Lecturer of Rheumatology and Rehabilitation, Faculty of Medicine - El-Azhar University - Damietta

Collaborator

Source ClinicalTrials.gov

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