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Recruiting NCT06998628

Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis

Phase II Interventional Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methotrexate, Pentoxifylline.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Drug Methotrexate
    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.
  • Drug Pentoxifylline
    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 outcome measures

  • change in Disease Activity Score (DAS28) [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine, Al-Azhar University — Damietta

Identifiers

NCT: NCT06998628 · 78956

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗