A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00109252
First received: April 26, 2005
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.


Condition Intervention Phase
Psoriasis
Drug: Raptiva (efalizumab)
Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab Followed by Efalizumab Taper in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

Resource links provided by NLM:


Further study details as provided by Genentech:

Estimated Enrollment: 0
Study Start Date: January 2002
Study Completion Date: April 2003
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Previous participation in Study ACD2390g
  • For women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study
  • Willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources throughout the study

Exclusion Criteria:

  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab
  • Systemic therapy for psoriasis (ET Day 0 through FU Day 84 or upon relapse or unusual presentation of psoriasis in the FU period, whichever occurs first)
  • Systemic immunosuppressive drugs for other indications (ET Day 0 through FU Day 84)
  • Topical therapies for psoriasis (ET Day 0 through ET Day 84)
  • Live virus or bacteria vaccines (ET Day 0 through FU Day 84)
  • Other vaccines or allergy desensitization (it is recommended that these be scheduled after FU Day 84)
  • Other experimental drugs or treatments (ET Day 0 through FU Day 84)
  • Beta-Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between ET Day 0 and TT Day 84)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00109252     History of Changes
Other Study ID Numbers: ACD2391g
Study First Received: April 26, 2005
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Plaque Psoriasis
Topical

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

ClinicalTrials.gov processed this record on April 15, 2014