Apremilast and Adalimumab in Psoriatic Arthritis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adalimumab, Apremilast.
- Who it may be relevant to
- Registry conditions: Psoriatic Arthritis, Ultrasound Assessment, TNF. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients
Overview
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
Interventions
- Drug Adalimumab
PsA patients who will receive Adalimumab with methotrexate therapy for 3 months - Drug Apremilast
PsA patients who will receive Apremilast with methotrexate therapy for 3 months
Primary outcome measures
- Disease Activity Index for Psoriatic Arthritis [Time frame: 3 months]
Secondary outcome measures (2)
- Health assessment questionnaire disability index [Time frame: 3 months]
- Psoriasis Area and Severity Index [Time frame: 3 months]
Eligibility criteria
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) .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07398651 · 36265MD4108/12 / 25