Apremilast and Adalimumab in Psoriatic Arthritis Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriatic Arthritis; Ultrasound Assessment; TNF
• Intervention / Treatment: Drug: Adalimumab; Drug: Apremilast

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MennaAllah Elmalla, Assistant lecturer; Phone Number: +20 10 94422540; Email: mennaallah.mohamed@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University
    • Contact: MennaAllah Elmalla, Assistant lecturer; Phone Number: +20 10 94422540; Email: mennaallah.mohamed@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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) .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; consists of 30 PsA patients who will receive Adalimumab with methotrexate therapy for 3 months.	Drug: Adalimumab; PsA patients who will receive Adalimumab with methotrexate therapy for 3 months
Experimental: Group II; consists of 30 PsA patients who will receive Apremilast with methotrexate therapy for 3 months.	Drug: Apremilast; PsA patients who will receive Apremilast with methotrexate therapy for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Index for Psoriatic Arthritis	Assessment of disease activity in psoriatic arthritis patients by Disease Activity Index for Psoriatic Arthritis	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health assessment questionnaire disability index	Functional assessment Using health assessment questionnaire disability index	3 months
Psoriasis Area and Severity Index	Psoriasis Area and Severity Index (PASI) for skin involvement	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Apremilast; Adalimumab; Psoriatic Arthritis Patients:
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Adalimumab; apremilast
• Other Study ID Numbers: 36265MD4108/12 / 25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data ill be available if it needed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No