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RecruitingNCT06998628Updated Oct 5, 2026

Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis

A Phase 2 interventional study of Methotrexate and Pentoxifylline in Rheumatoid Arthritis, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Updated Oct 5, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's planned enrollment of 50 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Control group

    will receive the traditional therapy of RA for three months.

    Drug: Methotrexate

  • Active comparator
    Pentoxifylline group

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

    Drug: Methotrexate · Drug: Pentoxifylline

Interventions

  • DrugMethotrexate

    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.

  • DrugPentoxifylline

    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

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine, Al-Azhar University
    Damietta, Damietta Governorate 34511, Egypt
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Primary completion
May 30, 2026→May 30, 2027
Oct 5, 2026
Study completion
Sep 30, 2026→Sep 30, 2027
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Primary completion May 30, 2026→May 30, 2027
    Study completion Sep 30, 2026→Sep 30, 2027
    + 3 other changes: verification date, oversight details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06998628
Lead sponsor
Tanta University
Collaborators
Dr. Mustafa Adel Mustafa Elmenawy Lecturer of Rheumatology and Rehabilitation, Faculty of Medicine - El-Azhar University - Damietta
Responsible party
Shrouk Ali Mohamed Elsies (Demonstrator, Tanta University) — Principal investigator
First posted
May 31, 2025
Start date
Jun 2, 2025
Primary completion
May 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Oct 5, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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