Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis

Sponsor
Horus University
Study ID
NCT07632846
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Roflumilast 500 Mcg Oral Tablet — DRUG
    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.
  • Placebo Group — DRUG
    Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
May 19, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Roflumilast Group
  • Experimental: Placebo Group

Primary Outcome Measure

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

Central Contacts

Find similar trials

Nationwide
Rheumatoid arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

Related Studies