Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis

Horus University

Status and phase: Enrolling; Phase 2

Conditions: Rheumatoid Arthritis (RA); Rheumatoid Arthritis

Treatments: Drug: Placebo Group; Drug: Roflumilast 500 Mcg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07632846

MDP.26.03.216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Roflumilast Group

Experimental group

Treatment:

Drug: Roflumilast 500 Mcg Oral Tablet

Placebo Group

Experimental group

Treatment:

Drug: Placebo Group