Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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 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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Monotherapy with Raptiva alone |
|
| B | Experimental | Combination therapy with both Raptiva and Methotrexate |
|
| C | Experimental | Continue Raptiva, discontinue methotrexate |
|
| D | Experimental | Continue combination therapy with both Raptiva and Methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Initial dose 5 mg, then 15 mg per week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PASI -- Psoriasis Area and Severity Index | (PASI) - given by numerical score, the index shows the severity of psoriasis. | 16 vs. 36 weeks, depending on study arm |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | measured by whether or not AE was serious | 16 vs. 36 weeks, depending on study arm |
Not provided
Inclusion Criteria:
We are seeking adults who:
You will:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chai Sue Lee, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center Department of Dermatology | Sacramento | California | 95816 | United States |
Not provided
| Label | URL |
|---|---|
| University of California-Davis Department of Dermatology Clinical Research | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A-Monotherapy With Raptiva Alone | Monotherapy with Raptiva alone Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg |
| FG001 | 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 |
| FG002 | C-Continue Raptiva, Discontinue Methotrexate | Continue Raptiva, discontinue methotrexate Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A-Monotherapy With Raptiva Alone | Monotherapy with Raptiva alone Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg |
| BG001 | B-Combination Therapy With Both Raptiva and Methotrexate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PASI -- Psoriasis Area and Severity Index | (PASI) - given by numerical score, the index shows the severity of psoriasis. | data not collected | Posted | 16 vs. 36 weeks, depending on study arm |
|
Not provided
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A-Monotherapy With Raptiva Alone | Monotherapy with Raptiva alone Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chai Sue Lee | Kaiser Permanente (Current), UC Davis (Previous) | lam.nguyen@ucdmc.ucdavis.edu |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| C472181 | efalizumab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Raptiva |
| Drug |
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg |
|
|
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
| BG002 | C-Continue Raptiva, Discontinue Methotrexate | Continue Raptiva, discontinue methotrexate Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| C-Continue Raptiva, Discontinue Methotrexate |
Continue Raptiva, discontinue methotrexate Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg |
| OG003 | 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 |
|
| Secondary | Adverse Events (AE) | measured by whether or not AE was serious | Data not collected | Posted | 16 vs. 36 weeks, depending on study arm |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | C-Continue Raptiva, Discontinue Methotrexate | Continue Raptiva, discontinue methotrexate Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |