N/A Completed N=734

Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

Psoriasis

Source: ClinicalTrials.gov NCT01155570 ↗

Enrolled (actual)

734

Serious AEs

4.8%

Results posted

Oct 2013

Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs — 237; 35; 191; 24 participants

Summary

The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug: * unknown adverse drug reactions, especially clinically significant adverse reactions * incidence and conditions of occurrence of adverse reactions in the clinical setting * factors that may affect the safety and effectiveness of Humira.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs	237; 35; 191; 24; 4; 48	—
PRIMARY Physician's Global Assessment at Week 4	2.2	<0.0001 sig
PRIMARY Physician's Global Assessment At Week 8	1.8	<0.0001 sig
PRIMARY Physician's Global Assessment at Week 16	1.5	<0.0001 sig
PRIMARY Physician's Global Assessment at Week 24	1.2	<0.0001 sig
PRIMARY Psoriasis Area and Severity Index (PASI) at Week 16	5.0	<0.0001 sig
PRIMARY Psoriasis Area and Severity Index (PASI) at Week 24	4.0	<0.0001 sig
PRIMARY Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16	49.2; 52.9	—
PRIMARY Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24	58.2; 62.1	—
PRIMARY Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16	27.0; 28.7	—
PRIMARY Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24	39.3; 41.7	—
PRIMARY Dermatology Life Quality Index at Week 16	3.01	<0.0001 sig
PRIMARY Dermatology Life Quality Index at Week 24	2.30	<0.0001 sig
PRIMARY Pain Visual Analog Scale (VAS) at Week 4	26.7	<0.0001 sig
PRIMARY Pain Visual Analog Scale (VAS) at Week 16	21.3	<0.0001 sig
PRIMARY Pain Visual Analog Scale (VAS) at Week 24	16.3	<0.0001 sig
PRIMARY Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4	3.0	<0.0001 sig
PRIMARY Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16	2.4	<0.0001 sig
PRIMARY Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24	2.3	<0.0001 sig
PRIMARY Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4	2.3	<0.0001 sig
PRIMARY Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16	2.0	<0.0001 sig
PRIMARY Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24	1.8	<0.0001 sig
SECONDARY Physician's Overall Response Rating At Week 24	354; 255; 65; 16; 10	—

Eligibility Criteria

Inclusion Criteria

All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be

those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or
patients with intractable eruptions of joint signs/symptoms.

Exclusion Criteria

Contraindications according to the Package Insert include patients who have any of the following:

serious infections
tuberculosis
a history of hypersensitivity to any ingredient of Humira
demyelinating disease or a history of demyelinating disease
congestive cardiac failure.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01155570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.