Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:39 PM
Study NCT ID:
NCT07398651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apremilast and Adalimumab in Psoriatic Arthritis Patients
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: