Psoriasis
Conditions
Keywords
psoriasis, etanercept, acitretin
Brief summary
To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.
Detailed description
This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the improvement of their PASI and PGA scores.
Interventions
DRUGacitretin
Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.
Sponsors
Connetics Corp.
University of Medicine and Dentistry of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 \[moderate\] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept * All patients on etanercept have been tested for TB before initiation of etanercept
Exclusion criteria
* Patients \< 18 years old or \> 80 years old * Patients who are not on etanercept 50 mg SQ once weekly * Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile \[bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation\] or post-menopausal for at least 2 years, are eligible) * Inability to understand consent or comply with study requirements * Uncontrolled hypertriglyceridemia * Patients with severely impaired hepatic function * Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests * Systemic psoriasis therapies or PUVA within the past 2 weeks * UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week * Patients with epilepsy or multiple sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy | 6 months | Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy | 6 months | Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease. |
| Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy | 6 months | Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept With Acitretin patients on etanercept taking open-label acitretin | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Etanercept With Acitretin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy
Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept With Acitretin | Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy | 12.5 percent |
Secondary
Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy
Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept With Acitretin | Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy | 37.5 percent |
Secondary
Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy
Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept With Acitretin | Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy | 50 percent |