Clinical trial

Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients Treated With Adalimumab and Methotrexate: Case Control Study

Name
TWEAK in plaque psoriasis
Description
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality. Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future. To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients, effective treatment of this immune-mediated systemic inflammatory disease is required
Trial arms
Trial start
2024-06-01
Estimated PCD
2025-06-01
Trial end
2025-06-10
Status
Not yet recruiting
Treatment
Adalimumab
To suggests the role of TWEAK and the effectiveness of different treatments like adalimumab and methotrexate in managing plaque psoriasis and psoriatic arthritis.
Arms:
Group A : (Adalimumab therapy), Group B : (methotrexate therapy), Group C: (control Group):
Other names:
Methotrexate
Size
100
Primary endpoint
Treatment of psoriasis vulgaris and psoriatic arthritis
1 year
Eligibility criteria
Inclusion Criteria: * Patients of both sexes with psoriasis vulgaris and Psoriatic arthritis. * Active PsA with three or more tender and swollen joints and met the CASPAR, despite previous treatment with NSAIDs, DMARDs or anti-TNFs Exclusion Criteria: * Previously received biologic immunomodulating agents, except for those targeting TNF * Previously been treated with three or more different TNF inhibitors * Active, ongoing inflammatory diseases other than PsA * Active TB (patients with latent TB had to commence treatment for latent TB before study entry) * A history of hepatitis B or C, human immunodeficiency virus, or any active systemic infection within the 2 weeks before baseline * History of ongoing, chronic or recurrent infections, or evidence of active TB infection * History of malignancy within the past 5 years (except for basal cell carcinoma or actinic keratosis that has been treated with no evidence of recurrence in the past 3 months, in situ cervical cancer or non-invasive malignant colon polyps that had been removed) * Underlying metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious or gastrointestinal conditions which, in the opinion of the investigator, immunocomprimised the patient and/or placed the patient at unacceptable risk for participation * Pregnant or nursing (lactating) women and women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-17

1 organization

1 product

1 indication

Organization
Egymedicalpedia
Product
Adalimumab
Indication
Psoriasis