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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00368654
First received: August 24, 2006
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Methotrexate
Drug: Raptiva
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • PASI -- psoriasis area and severity index [ Time Frame: 16 vs. 36 weeks, depending on study arm ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events, whether or not serious [ Time Frame: 16 vs. 36 weeks, depending on study arm ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Monotherapy with Raptiva alone
Drug: Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
Other Name: Efalizumab
Experimental: B
Combination therapy with both Raptiva and Methotrexate
Drug: Methotrexate
Initial dose 5 mg, then 15 mg per week
Drug: Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
Other Name: Efalizumab
Experimental: C
Continue Raptiva, discontinue methotrexate
Drug: Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
Other Name: Efalizumab
Experimental: D
Continue combination therapy with both Raptiva and Methotrexate
Drug: Methotrexate
Initial dose 5 mg, then 15 mg per week
Drug: Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
Other Name: Efalizumab

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368654

Locations
United States, California
University of California, Davis Medical Center Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Genentech
Investigators
Principal Investigator: Chai Sue Lee, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00368654     History of Changes
Other Study ID Numbers: 200513613-1
Study First Received: August 24, 2006
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014