Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 70

Pentoxifylline added to methotrexate for rheumatoid arthritis inflammation

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

Run by Tanta University · NCT06998628 · Data updated 2026-11-12

This trial tests whether adding pentoxifylline to standard methotrexate treatment reduces inflammation and improves symptoms in adults with active rheumatoid arthritis.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment50 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Damietta, Damietta Governorate)
StatusRecruiting
StartedJune 2, 2025
Main results expectedMay 30, 2027
Study endsSeptember 30, 2027
Registry record updatedOctober 5, 2026
Trial IDNCT06998628 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–70 years old with active rheumatoid arthritis (DAS28 > 2.6) who are receiving conventional DMARD therapy and do not have contraindicating liver, kidney, bleeding, or pregnancy-related issues are ideal candidates.

Probably not a fit

People in remission, those already taking biologic or synthetic DMARDs, pregnant or breastfeeding individuals, or patients with significant hepatic, renal, or bleeding disorders are unlikely to benefit or are not eligible for this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study conducted at Egyptian university sites testing pentoxifylline as an anti-inflammatory adjunct to conventional disease‑modifying therapy (methotrexate) in adults with active rheumatoid arthritis. Eligible participants are adults aged 18–70 with active disease (DAS28 > 2.6) who are already on conventional DMARDs; patients on biologic or synthetic DMARDs, pregnant or lactating individuals, and those with significant liver, kidney, or bleeding disorders are excluded. The study compares clinical disease activity and inflammatory markers over the treatment period to see if pentoxifylline provides additional benefit. Safety and tolerability, including adverse events related to hepatic, renal, or bleeding risks, are monitored throughout the trial.

Why it matters

Potential benefit: If successful, adding pentoxifylline could offer a well‑tolerated, low‑cost oral option to further reduce joint inflammation and improve symptoms when used with methotrexate.

How similar studies have gone: Pentoxifylline has known anti‑inflammatory effects and small prior studies in inflammatory conditions, including limited RA research, suggest possible benefit but the evidence remains inconclusive.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Faculty of Medicine, Al-Azhar University
    Damietta, Damietta Governorate, Egypt
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.