Efalizumab |
Raptiva |
Clinical Trial: A Study to Evaluate Raptiva in Adults with Plaque Psoriasis Previously Enrolled in Study ACD2390g
This study has been completed.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Psoriasis | Drug: Raptiva (efalizumab) | Phase III |
MedlinePlus related topics: Psoriasis
Study Type: Interventional
Study Design: Treatment, Open Label
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
Eligibility
Genders Eligible for Study: Both
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)
More Information
Record last reviewed: April 2005
Last Updated: April 25, 2005
Record first received: April 25, 2005
ClinicalTrials.gov Identifier: NCT00109252
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005
Resources
- Efalizumab (Drug Digest)
- Raptiva (Drug Digest)

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