Apremilast and Adalimumab in Psoriatic Arthritis Patients

NCT07398651 | Not Yet Recruiting

• 1 other identifier: 36265MD4108/12 / 25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriatic Arthritis; Ultrasound Assessment; TNF

Keywords

Psoriatic Arthritis Patients:; Apremilast; Adalimumab

Outcome Measures

Primary Outcomes (1)

• Disease Activity Index for Psoriatic Arthritis

  Assessment of disease activity in psoriatic arthritis patients by Disease Activity Index for Psoriatic Arthritis

  3 months

Secondary Outcomes (2)

• Health assessment questionnaire disability index

  3 months

• Psoriasis Area and Severity Index

  3 months

Study Arms (2)

Group I

EXPERIMENTAL

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

Drug: Adalimumab

Group II

EXPERIMENTAL

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

Drug: Apremilast

Interventions

Adalimumab DRUG

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

Group I

Apremilast DRUG

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

Group II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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) .

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Adalimumab; apremilast

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

MennaAllah Elmalla, Assistant lecturer

CONTACT

+20 10 94422540; mennaallah.mohamed@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Rheumatology, Rehabilitation & Physical Medicine

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 10, 2026
• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)