Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis

NCT06998628 | Recruiting Phase 2

• 1 other identifier: 78956
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

will receive the traditional therapy of RA for three months.

Drug: Methotrexate

Pentoxifylline group

ACTIVE COMPARATOR

will receive 400 mg pentoxifylline two times daily plus the traditional therapy of RA for three months.

Drug: Methotrexate; Drug: Pentoxifylline

Interventions

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.

Control group; Pentoxifylline group

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

Pentoxifylline group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead
• Prof. Sahar Kamal Hegazy, Professor of Clinical Pharmacy, Faculty of Pharmacy - Tanta University: collaborator
• Dr. Mustafa Adel Mustafa Elmenawy Lecturer of Rheumatology and Rehabilitation, Faculty of Medicine - El-Azhar University - Damietta: collaborator

Study Sites (1)

Faculty of Medicine, Al-Azhar University

Damietta, Damietta Governorate, 34511, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; Pentoxifylline

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Theobromine; Xanthines; Purinones; Purines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)