Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis

Sponsor
Horus University
Study ID
NCT07566351
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast administered orally as add-on therapy to standard disease-modifying antirheumatic drugs
  • Desloratadine — DRUG
    Desloratadine administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.
  • Placebo — DRUG
    Matching placebo administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.

Study Details

Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and disability. Although standard disease-modifying antirheumatic drugs (DMARDs) are effective for many patients, some individuals continue to experience active disease and inflammation. The aim of this study is to evaluate the effectiveness and safety of adding either roflumilast or desloratadine to standard DMARD therapy in patients with rheumatoid arthritis. Participants will be randomly assigned to receive either roflumilast, desloratadine, or placebo in addition to their usual treatment. The study will assess changes in disease activity, inflammatory biomarkers, and patient-reported outcomes over a three-month follow-up period. The results of this study may help identify new add-on treatment options to improve disease control in patients with rheumatoid arthritis.

Key Dates

Start date
Apr 23, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast
    Participants will receive roflumilast in addition to standard disease-modifying antirheumatic drug therapy.
  • Experimental: Desloratadine
    Participants will receive desloratadine in addition to standard disease-modifying antirheumatic drug therapy.
  • Experimental: Placebo
    Participants will receive placebo in addition to standard disease-modifying antirheumatic drug therapy.

Primary Outcome Measure

Change in Disease Activity Score (DAS28) [ Time Frame: Baseline to 12 weeks ]

Central Contacts

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