A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00096980
First received: November 17, 2004
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

This study is an open label, randomized, multicenter study designed to compare the efficacy of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects who derive benefit from the initial 12 weeks of treatment.


Condition Intervention Phase
Psoriasis
Drug: Raptiva (efalizumab)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneously Administered Efalizumab Used in Combination With Topical Psoriasis Therapies for Prolonged Maintenance Treatment

Resource links provided by NLM:


Further study details as provided by Genentech:

Estimated Enrollment: 300
Study Start Date: February 2001
Study Completion Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Diagnosis of plaque psoriasis for >=6 months
  • A minimum Psoriasis Area and Severity Index (PASI) score of 12.0 at screening
  • Plaque psoriasis covering >=10% of total Body Surface Area (BSA)
  • In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or who has received prior systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil [MMF], thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP, etanercept)
  • 18 to 70 years old

Exclusion Criteria:

  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  • Clinically significant psoriasis flare during the 3 months prior to enrollment
  • Pregnancy or lactation
  • History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
  • History of opportunistic infections (e.g., systemic fungal infections, parasites)
  • Seropositivity for hepatitis B or C virus
  • Seropositivity for human immunodeficiency virus (HIV)
  • History of active tuberculosis (TB) or currently undergoing treatment for TB
  • Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
  • Diagnosis of hepatic cirrhosis, regardless of cause or severity
  • Hospital admission for cardiovascular or pulmonary disease within the last year
  • History of substance abuse within the last 5 years
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an immunoglobulin (Ig) Fc region (e.g., etanercept, LFA3TIP)
  • History of severe allergic reactions to or intolerance of topical corticosteroid therapies
  • Previous treatment with efalizumab
  • History of treatment with lymphocyte-depleting monoclonal antibodies or immunoadhesion molecules (e.g., anti-CD4, CTLA4-Ig, LFA3TIP)
  • WBC count <4000/uL or >14,000/uL
  • Hepatic enzymes >=3 times the upper limit of normal
  • Creatinine >=2 times the upper limit of normal
  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
  • Any medical or other condition that, in the judgment of the investigator, would significantly interfere with the subject's ability to comply with the provisions of this protocol
  • Topical therapy for psoriasis
  • Systemic therapy for psoriasis
  • Systemic immunosuppressive drugs
  • Tanning beds, booths, or home UV light sources
  • Live virus or bacteria vaccine
  • Other vaccines or allergy desensitization injections
  • Other experimental drugs or treatments
  • Nonsteroidal anti inflammatory drugs
  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.

No Contacts or Locations Provided
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00096980     History of Changes
Other Study ID Numbers: ACD2243g
Study First Received: November 17, 2004
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014