Phase 2
Completed N=12
Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy
Source: ClinicalTrials.gov NCT00368654 ↗Enrolled (actual)
12
Serious AEs
—
Results posted
Jun 2018
Primary outcomePrimary: PASI -- Psoriasis Area and Severity Index
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PASI -- Psoriasis Area and Severity Index |
— | — |
| SECONDARY Adverse Events (AE) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00368654). 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.