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OpenTrials
Completed

NCT Number: NCT00368654

Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California, Davis Medical Center Department of Dermatology

Sacramento, California, 95816, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

Initial dose 5 mg, then 15 mg per week

Raptiva

Drug

Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg

Other names: Efalizumab

Primary outcomes

  1. PASI -- Psoriasis Area and Severity Index

    Time frame: 16 vs. 36 weeks, depending on study arm

    (PASI) - given by numerical score, the index shows the severity of psoriasis.

Secondary outcomes

  1. Adverse Events (AE)

    Time frame: 16 vs. 36 weeks, depending on study arm

    measured by whether or not AE was serious

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

An Open-Label Study to Evaluate Whether a Short-Term Course of Methotrexate in Psoriasis Patients Treated With Efalizumab is Safe and Increases Efficacy

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 25, 2006
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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