Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis

NCT07632846 | Recruiting Phase 2

• 1 other identifier: MDP.26.03.216
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Rheumatoid Arthritis (RA)

Keywords

Roflumilast; Rheumatoid arthritis; Randomized controlled trial; Phosphodiesterase-4 inhibitor; Add-on therapy

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity Score (DAS28)

  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.

  12 weeks

Secondary Outcomes (1)

• 2. Change in serum inflammatory biomarkers

  12 weeks

Study Arms (2)

Roflumilast Group

EXPERIMENTAL

Drug: Roflumilast 500 Mcg Oral Tablet

Placebo Group

EXPERIMENTAL

Drug: Placebo Group

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.

Also known as: Roflumilast

Roflumilast Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Faculty of Pharmacy, Horus University in Egypt

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Roflumilast; Tablets

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Amira Mashaly

CONTACT

01028275001; amashaly@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to two group to receive either roflumilast or placebo in addition to standard therapy.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 8, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

EG (1)