Apremilast and Adalimumab in Psoriatic Arthritis Patients

Tanta University

Status: Begins enrollment in 8 months

Conditions: Ultrasound Assessment; Psoriatic Arthritis; TNF

Treatments: Drug: Adalimumab; Drug: Apremilast

Study type: Interventional

Funder types: Other

Identifiers

NCT07398651

36265MD4108/12 / 25

Details and patient eligibility

About

The aim of this work is to compare the efficacy of Apremilast combined with Methotrexate versus Adalimumab combined with Methotrexate

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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) .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group I

Experimental group

Description:

consists of 30 PsA patients who will receive Adalimumab with methotrexate therapy for 3 months.

Treatment:

Drug: Adalimumab

Group II

Experimental group

Description:

consists of 30 PsA patients who will receive Apremilast with methotrexate therapy for 3 months.

Treatment:

Drug: Apremilast