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NCT Number: NCT07398651

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) .

Treatment and study plan

Adalimumab

Drug

PsA patients who will receive Adalimumab with methotrexate therapy for 3 months

Apremilast

Drug

PsA patients who will receive Apremilast with methotrexate therapy for 3 months

Primary outcomes

  1. 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

Secondary outcomes

  1. Health assessment questionnaire disability index

    Time frame: 3 months

    Functional assessment Using health assessment questionnaire disability index

  2. Psoriasis Area and Severity Index

    Time frame: 3 months

    Psoriasis Area and Severity Index (PASI) for skin involvement

Study contacts

Contact information is provided by the study sponsor or research team.

MennaAllah Elmalla, Assistant lecturer

CONTACT

[email protected]

+20 10 94422540

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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