Psoriasis
Conditions
Brief summary
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
Detailed description
The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate. The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly
Interventions
DRUGMethotrexate
Initial dose 5 mg, then 15 mg per week
DRUGRaptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
Sponsors
Genentech, Inc.
University of California, Davis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Moderate to severe plaque-type psoriasis * A candidate for systemic therapy or phototherapy * Not using prescription systemic therapies for psoriasis prior to starting the study * Not using efalizumab within 3 months prior to starting the study We are seeking adults who: * Have moderate to severe plaque-type psoriasis * Are generally healthy * Are not hypersensitive to Raptiva® (efalizumab) or any of its components. * Are not pregnant or lactating women You will: * Be interviewed and examined * Have blood drawn * Be injecting the study medication
Exclusion criteria
* Hypersensitivity to Raptiva or any of its components * Pregnant or lactating women * History of liver disease or abnormal liver enzymes * History of chronic infection or malignancy * History of significant hematologic abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PASI -- Psoriasis Area and Severity Index | 16 vs. 36 weeks, depending on study arm | (PASI) - given by numerical score, the index shows the severity of psoriasis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AE) | 16 vs. 36 weeks, depending on study arm | measured by whether or not AE was serious |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A-Monotherapy With Raptiva Alone Monotherapy with Raptiva alone
Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg | 3 |
| B-Combination Therapy With Both Raptiva and Methotrexate Combination therapy with both Raptiva and Methotrexate
Methotrexate: Initial dose 5 mg, then 15 mg per week
Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg | 3 |
| C-Continue Raptiva, Discontinue Methotrexate Continue Raptiva, discontinue methotrexate
Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg | 3 |
| D-Continue Combination Therapy With Both Raptiva and Methotrex Continue combination therapy with both Raptiva and Methotrexate
Methotrexate: Initial dose 5 mg, then 15 mg per week
Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | A-Monotherapy With Raptiva Alone | B-Combination Therapy With Both Raptiva and Methotrexate | C-Continue Raptiva, Discontinue Methotrexate | D-Continue Combination Therapy With Both Raptiva and Methotrex | Total |
|---|---|---|---|---|---|
| Age, Continuous | NA years | NA years | NA years | NA years | NA years |
| Region of Enrollment United States | 3 participants | 3 participants | 3 participants | 3 participants | 12 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
PASI -- Psoriasis Area and Severity Index
(PASI) - given by numerical score, the index shows the severity of psoriasis.
Time frame: 16 vs. 36 weeks, depending on study arm
Population: data not collected
Secondary
Adverse Events (AE)
measured by whether or not AE was serious
Time frame: 16 vs. 36 weeks, depending on study arm
Population: Data not collected