Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis

Phase 2

Not yet recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate; Drug: Pentoxifylline

• Registration Number: NCT06998628
• Lead Sponsor: Tanta University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study Start: 2025-05-30
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2026-05-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Methotrexate	will receive the traditional therapy of RA for three months.
Pentoxifylline group	Methotrexate	will receive 400 mg pentoxifylline two times daily plus the traditional therapy of RA for three months.
Pentoxifylline group	Pentoxifylline	will receive 400 mg pentoxifylline two times daily plus the traditional therapy of RA for three months.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Medicine, Al-Azhar University; 🇪🇬 Damietta, Egypt