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NCT Number: NCT06998628

Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Al-Azhar University

Damietta, Damietta Governorate, 34511, Egypt

Location status: Recruiting

Location contact

Shrouk Ali, M.Sc

CONTACT

[email protected]

01009264128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. change in Disease Activity Score (DAS28)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

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

Registry information

Official study title

Clinical Study Evaluating the Effect of Pentoxifylline as Anti Inflammatory in Patients With Rheumatoid Arthritis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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