Pentoxifylline added to methotrexate for rheumatoid arthritis inflammation
Clinical Study Evaluating the Effect of Pentoxifylline as Anti Inflammatory in Patients With Rheumatoid Arthritis
This trial tests whether adding pentoxifylline to standard methotrexate treatment reduces inflammation and improves symptoms in adults with active rheumatoid arthritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Damietta, Damietta Governorate) |
| Trial ID | NCT06998628 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Damietta, Damietta Governorate
- Faculty of Medicine, Al-Azhar University — Damietta, Damietta Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.