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Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis

NCT07632846 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-08

No results posted yet for this study

Summary

Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and reduced physical function. Although standard disease-modifying antirheumatic drugs are effective for many patients, some individuals continue to have active disease.

The purpose of this study is to evaluate the effectiveness and safety of adding roflumilast to standard therapy in patients with active rheumatoid arthritis. Participants will receive either roflumilast or placebo in addition to their usual treatment.

The study will assess changes in disease activity and inflammatory markers over a follow-up period of approximately 12 weeks. The results of this study may help determine whether roflumilast could be a useful add-on treatment option for patients with rheumatoid arthritis.

Conditions

Interventions

DRUG

Roflumilast 500 Mcg Oral Tablet

Roflumilast is an oral phosphodiesterase 4 inhibitor administered as add on therapy to standard disease modifying antirheumatic drug treatment. It is used to evaluate its potential anti-inflammatory effects on disease activity and inflammatory markers in patients with active rheumatoid arthritis.

DRUG

Placebo Group

Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.

Sponsors & Collaborators

  • Horus University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-19
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632846 on ClinicalTrials.gov