Psoriatic ArthritisNCT07398651
Apremilast and Adalimumab in Psoriatic Arthritis Patients
A study testing Adalimumab and Apremilast in people with Psoriatic Arthritis and Ultrasound Assessment, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this work is to compare the efficacy of Apremilast combined with Methotrexate versus Adalimumab combined with Methotrexate Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriatic Arthritis, Ultrasound Assessment, TNF
- What is being tested?
- Adalimumab and Apremilast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2026to 30 Dec 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will include 60 adult Psoriatic arthritis patients >18 years old, fulfilling the (CASPAR) classification criteria of Psoriatic arthritis and have an inadequate response to methotrexate therapy for at least 3 months.
- Psoriatic arthritis patients with peripheral musculoskeletal domains (peripheral arthritis, dactylitis and enthesitis) as well as skin and nail domains
Who cannot join
- Patients who received previous biologic agents or Janus kinase inhibitors.
- Patients with axial and ocular involvement.
- Current or recent serious infection including tuberculosis or hepatitis B/C .
- Current or past history of malignancy (within five year).
- Pregnant or breastfeeding women or women planning pregnancy during the study period .
- Severe uncontrolled comorbidities such as heart failure, severe liver disease, or chronic kidney disease (eGFR <30 mL/min/1.73m²) .
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
Tanta University
Tanta
MennaAllah Elmalla, Assistant lecturer, +20 10 94422540, mennaallah.mohamed@med.tanta.edu.eg
About this study
Official title: Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients
The aim of this work is to compare the efficacy of Apremilast combined with Methotrexate versus Adalimumab combined with Methotrexate
Read the detailed description
Psoriatic arthritis is a heterogeneous chronic systemic auto-immune disease, with variable musculoskeletal involvement as well as skin and nail disease . Up to 30% of patients with psoriasis may develop Psoriatic arthritis over the course of their lifetime. Musculoskeletal manifestations of Psoriatic arthritis include peripheral arthritis, spondylitis, dactylitis and enthesitis.
The pathogenesis of Psoriatic arthritis is still unclear, due to the heterogeneity of the pathogenic pathways involved, the variable clinical manifestations, and different responses to treatment.
A predisposing genetic background in the presence of environmental factors, such as infections, microbiota (dysbiosis), obesity, biomechanical stress could activate the immune system and precipitate the onset of the disease.
Objectives:
- Assessment of the effect of the studied drugs on the disease activity clinically and laboratory in PsA patients.
- Assessment of the effect of the studied drugs on functional status of PsA patients.
- Evaluation of the effect of the studied drugs on the musculoskeletal ultrasound findings of PsA patients
Objectives:
- Assessment of the effect of the studied drugs on the disease activity clinically and laboratory in PsA patients.
- Assessment of the effect of the studied drugs on functional status of PsA patients.
- Evaluation of the effect of the studied drugs on the musculoskeletal ultrasound findings of PsA patients
Musculoskeletal ultrasound is considered one of the most important tools in studying the effects of rheumatic diseases on musculoskeletal structures.
It is demonstrated that ultrasound is more sensitive than conventional radiography and clinical examination for the assessment of inflammatory and structural changes in inflammatory arthritis, including Psoriatic arthritis, and particularly synovitis, enthesitis, tenosynovitis, and bursitis.
The treatment of Psoriatic arthritis requires attention to the active domains present in each patient. If the major active domain is peripheral arthritis, treatment usually begins with non-steroidal anti-inflammatory drugs to control symptoms of pain and mild inflammation. If these drugs fail to control disease activity, a conventional synthetic DMARDs is usually prescribed, most commonly methotrexate. Leflunomide and sulfasalazine have also been used in the management of peripheral joint disease. The European Alliance of Associations for Rheumatology guidelines on the management of Psoriatic arthritis with drug therapies suggest that if patients do not attain a satisfactory response
- Conditions
- Psoriatic Arthritis, Ultrasound Assessment, TNF
- Being tested
- Adalimumab, Apremilast
- Keywords
- Psoriatic Arthritis Patients:, Apremilast, Adalimumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
PsA patients who will receive Adalimumab with methotrexate therapy for 3 months
ApremilastDrug
PsA patients who will receive Apremilast with methotrexate therapy for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | consists of 30 PsA patients who will receive Adalimumab with methotrexate therapy for 3 months. Receives: Drug: Adalimumab |
| Group II | Experimental | consists of 30 PsA patients who will receive Apremilast with methotrexate therapy for 3 months. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Index for Psoriatic Arthritis
Assessment of disease activity in psoriatic arthritis patients by Disease Activity Index for Psoriatic Arthritis
Measured: 3 months
Secondary outcomes (2)
Health assessment questionnaire disability index
Functional assessment Using health assessment questionnaire disability index
Measured: 3 months
Psoriasis Area and Severity Index
Psoriasis Area and Severity Index (PASI) for skin involvement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MenaaAllah Mohamed Elmalla, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398651
- Sponsor's protocol ID
- 36265MD4108/12 / 25
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data ill be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients
- ClinicalTrials.gov ID
- NCT07398651
- Acronym / sponsor ID
- 36265MD4108/12 / 25
- Conditions
- Psoriatic Arthritis, Ultrasound Assessment, TNF
- Keywords
- Psoriatic Arthritis Patients:, Apremilast, Adalimumab
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Feb 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.
The aim of this work is to compare the efficacy of Apremilast combined with Methotrexate versus Adalimumab combined with Methotrexate
Detailed description
Psoriatic arthritis is a heterogeneous chronic systemic auto-immune disease, with variable musculoskeletal involvement as well as skin and nail disease . Up to 30% of patients with psoriasis may develop Psoriatic arthritis over the course of their lifetime. Musculoskeletal manifestations of Psoriatic arthritis include peripheral arthritis, spondylitis, dactylitis and enthesitis.
The pathogenesis of Psoriatic arthritis is still unclear, due to the heterogeneity of the pathogenic pathways involved, the variable clinical manifestations, and different responses to treatment.
A predisposing genetic background in the presence of environmental factors, such as infections, microbiota (dysbiosis), obesity, biomechanical stress could activate the immune system and precipitate the onset of the disease.
Objectives:
- Assessment of the effect of the studied drugs on the disease activity clinically and laboratory in PsA patients.
- Assessment of the effect of the studied drugs on functional status of PsA patients.
- Evaluation of the effect of the studied drugs on the musculoskeletal ultrasound findings of PsA patients
Objectives:
- Assessment of the effect of the studied drugs on the disease activity clinically and laboratory in PsA patients.
- Assessment of the effect of the studied drugs on functional status of PsA patients.
- Evaluation of the effect of the studied drugs on the musculoskeletal ultrasound findings of PsA patients
Musculoskeletal ultrasound is considered one of the most important tools in studying the effects of rheumatic diseases on musculoskeletal structures.
It is demonstrated that ultrasound is more sensitive than conventional radiography and clinical examination for the assessment of inflammatory and structural changes in inflammatory arthritis, including Psoriatic arthritis, and particularly synovitis, enthesitis, tenosynovitis, and bursitis.
The treatment of Psoriatic arthritis requires attention to the active domains present in each patient. If the major active domain is peripheral arthritis, treatment usually begins with non-steroidal anti-inflammatory drugs to control symptoms of pain and mild inflammation. If these drugs fail to control disease activity, a conventional synthetic DMARDs is usually prescribed, most commonly methotrexate. Leflunomide and sulfasalazine have also been used in the management of peripheral joint disease. The European Alliance of Associations for Rheumatology guidelines on the management of Psoriatic arthritis with drug therapies suggest that if patients do not attain a satisfactory response
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Adalimumabconsists of 30 PsA patients who will receive Adalimumab with methotrexate therapy for 3 months. |
| Group II | Experimental | Drug: Apremilastconsists of 30 PsA patients who will receive Apremilast with methotrexate therapy for 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- This study will include 60 adult Psoriatic arthritis patients >18 years old, fulfilling the (CASPAR) classification criteria of Psoriatic arthritis and have an inadequate response to methotrexate therapy for at least 3 months.
Key exclusion criteria (6 listed)
- Patients who received previous biologic agents or Janus kinase inhibitors.
- Patients with axial and ocular involvement.
- Current or recent serious infection including tuberculosis or hepatitis B/C .
- Current or past history of malignancy (within five year).
- Pregnant or breastfeeding women or women planning pregnancy during the study period .
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 |
|---|---|---|
| AdalimumabPsA patients who will receive Adalimumab with methotrexate therapy for 3 months | Drug | Group I |
| ApremilastPsA patients who will receive Apremilast with methotrexate therapy for 3 months | Drug | Group II |
Primary outcome
Disease Activity Index for Psoriatic Arthritis
Time frame: 3 months
Assessment of disease activity in psoriatic arthritis patients by Disease Activity Index for Psoriatic Arthritis
2 secondary outcomes
Health assessment questionnaire disability index
Time frame: 3 months
Psoriasis Area and Severity Index
Time frame: 3 months
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 Sep 2026.
- Individual participant dataSharing planned: Yes. All data ill be available if it needed
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
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Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
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A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
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Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
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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 study testing Adalimumab and Apremilast in people with Psoriatic Arthritis and Ultrasound Assessment, run by Tanta 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Sep 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.
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 MennaAllah Elmalla, Assistant lecturer (+20 10 94422540, mennaallah.mohamed@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Index for Psoriatic Arthritis (time frame: 3 months). 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 Sep 2026.