Rheumatoid ArthritisPhase 2NCT07632846
Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis
A Phase 2 study testing Roflumilast 500 Mcg Oral Tablet in people with Rheumatoid Arthritis and Rheumatoid Arthritis (RA), run by Horus University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
- What is being tested?
- Roflumilast 500 Mcg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnant or breastfeeding patients.
- History of cardiac arrhythmias or prolonged QT interval.
- Use of medications known to prolong the QT interval
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Pharmacy, Horus University in Egypt
Al Mansurah
Amira Mashaly, 01028275001, amashaly@horus.edu.eg
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
- Being tested
- Roflumilast 500 Mcg Oral Tablet, Placebo Group
- Keywords
- Roflumilast, Rheumatoid arthritis, Randomized controlled trial, Phosphodiesterase-4 inhibitor, Add-on therapy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast 500 Mcg Oral TabletDrug
Also called Roflumilast
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 GroupDrug
Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast Group | Experimental | Not described Receives: Drug: Roflumilast 500 Mcg Oral Tablet |
| Placebo Group | Experimental | Not described Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
2. Change in serum inflammatory biomarkers
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start19 May 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to two group to receive either roflumilast or placebo in addition to standard therapy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Fawzy Mohamed Mashaly, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632846
- Sponsor's protocol ID
- MDP.26.03.216
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07632846
- Acronym / sponsor ID
- MDP.26.03.216
- Conditions
- Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
- Keywords
- Roflumilast, Rheumatoid arthritis, Randomized controlled trial, Phosphodiesterase-4 inhibitor, Add-on therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to two group to receive either roflumilast or placebo in addition to standard therapy.
| Arm | Type | Receives |
|---|---|---|
| Roflumilast Group | Experimental | Drug: Roflumilast 500 Mcg Oral Tablet |
| Placebo Group | Experimental | Drug: Placebo Group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast 500 Mcg Oral TabletAlso: RoflumilastRoflumilast 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. | Drug | Roflumilast Group |
| Placebo GroupMatching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast. | Drug | Placebo Group |
Primary outcome
Change in Disease Activity Score (DAS28)
Time frame: 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.
1 secondary outcome
2. Change in serum inflammatory biomarkers
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast 500 Mcg Oral Tablet in people with Rheumatoid Arthritis and Rheumatoid Arthritis (RA), run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Mashaly (01028275001, amashaly@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Score (DAS28) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.