Menu
Recruiting NCT07632846

Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis

Phase II Interventional Rheumatoid Arthritis Rheumatoid Arthritis (RA)

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: Roflumilast 500 Mcg Oral Tablet, Placebo Group.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Rheumatoid Arthritis (RA). Basic parameters: 18 years — 60 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 →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

rheumatoid arthritis. Roflumilast, a selective phosphodiesterase-4 inhibitor, reduces the production of pro-inflammatory cytokines, This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of roflumilast as add-on therapy to standard DMARD treatment in patients with rheumatoid arthritis. Eligible participants will be randomized into two parallel groups to receive either roflumilast, or placebo for a duration of three months.

Clinical assessments will include evaluation of disease activity scores, inflammatory biomarkers, and patient-reported outcomes. Safety and tolerability will be monitored throughout the study period. The findings of this study may provide evidence for novel adjunctive therapeutic strategies in the management of rheumatoid arthritis.

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.

Primary outcome measures

  • Change in Disease Activity Score (DAS28) [Time frame: 12 weeks]
Secondary outcome measures (1)
  • 2. Change in serum inflammatory biomarkers [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.
  • Disease Activity Score in 28 joints (DAS28) greater than 2.6.
  • Age between 18 and 60 years.
  • Male and female patients.
  • Patients receiving methotrexate in addition to standard conventional therapy.
  • Ability to provide written informed consent.

Exclusion criteria

  • Exclusion Criteria:
  • Patients with renal or hepatic disease.
  • Known hypersensitivity to the study medications.
  • Current use of antioxidant supplements.
  • History of psychiatric disorders.
  • Use of oral prednisolone at a dose greater than 15 mg per day.
  • Current treatment with biological disease modifying antirheumatic drugs.
  • Pregnant or breastfeeding patients.
  • History of cardiac arrhythmias or prolonged QT interval.
  • Use of medications known to prolong the QT interval

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
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Pharmacy, Horus University in Egypt — Al Mansurah

Identifiers

NCT: NCT07632846 · MDP.26.03.216

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗