Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Conditions
Keywords
Roflumilast, Rheumatoid arthritis, Randomized controlled trial, Phosphodiesterase-4 inhibitor, Add-on therapy
Brief 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.
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
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.
DRUGPlacebo Group
Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.
Sponsors
Horus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
Intervention model description
Participants are randomly assigned to two group to receive either roflumilast or placebo in addition to standard therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity Score (DAS28) | 12 weeks | Change in disease activity assessed by the Disease Activity Score in 28 joints (DAS28), calculated using tender and swollen joint counts, patient global assessment, and inflammatory markers. DAS28 values are interpreted as follows: remission is defined as a score less than 2.6, low disease activity as 2.6 to 3.2, moderate disease activity as greater than 3.2 to 5.1, and high disease activity as greater than 5.1. The outcome compares DAS28 values at baseline and after 12 weeks of treatment with roflumilast or placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2. Change in serum inflammatory biomarkers | 12 weeks | Change in serum levels of inflammatory biomarkers including interleukin-17 (IL-17), monocyte chemoattractant protein-1 (MCP 1), Cyclic adenosine monophosphate (cAMP), and malondialdehyde (MDA). |
Countries
Egypt
Contacts
CONTACTAmira Mashaly
Outcome results
None listed