NCT00442650

CompletedPhase 3

Efalizumab for Treatment of Patients With Moderate to Severe...

Merck KGaA, Darmstadt, Germany Source

Compare

Other study identifiers

Sponsor study identifier

25030

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

January 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2005

Actual (reported)

Study Completion

December 2005

Actual (reported)

Brief Summary

Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments involved physical examination, disease activity assessments, clinical laboratory tests (haematology, blood chemistry and standard urinalysis), evaluation of the Psoriasis Area and Severity Index (PASI), the Physician's Global Assessment (PGA), the Patient's Global Psoriasis Assessment (PGPA), the SF-36 Health Survey and psoriatic body surface area (BSA). The 12-week treatment period was followed by a 12-week follow-up (FU) period, during which other antipsoriatic medications were allowed. The same assessments were also performed in the 12-week FU period.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: December 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2005
Actual (reported)
Study Completion
December 2005
Actual (reported)
First Submitted
February 28, 2007
Actual (reported)
First Posted
March 2, 2007
Actual (reported)

Last Updated: November 21, 2016
Status Verified: March 2009
Last Update Submitted: November 18, 2016

Conditions

Moderate to Severe Psoriasis

Interventions

EfalizumabDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed informed consent
Plaque psoriasis covering ³10% of total BSA

Sponsors & Collaborators

Merck KGaA, Darmstadt, Germany
Industrylead

Study Sites (1)

Merck Serono Medical Information Office

Geneva, Switzerland

Related Publications (1)

Tsai TF, Liu MT, Liao YH, Licu D. Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study. J Eur Acad Dermatol Venereol. 2008 Mar;22(3):345-52. doi: 10.1111/j.1468-3083.2007.02430.x. Epub 2007 Nov 14.
PMID: 18005021RESULT

MeSH Terms

Interventions

efalizumab

Study Officials

Daiana Licu, MD
Merck Serono International SA
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 2, 2007

Study Start

January 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2005

Actual (reported)

NCT00096603

A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g

Phase 3Completed

NCT00109252

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

Phase 3Completed

NCT00287118

A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis

Phase 4Completed

NCT00382512

A Study to Evaluate the Effects of Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis

Phase 1Completed

NCT00184366

Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

Terminated

NCT00312026

A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet

Phase 4Completed

Diagnosis of plaque psoriasis for at least 6 months

A minimum PASI score of 12.0 at screening

In the opinion of the investigator, candidate for systemic therapy for psoriasis

Body weight of £120 kg

to 75 years old

For women of childbearing potential and for men whose partner can become pregnant, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study (including the FU period).

Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study

Willingness to enter Study

You may not qualify if:

Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies or fusion proteins that contain an Ig Fc region
Clinically significant psoriasis flare during screening or at the time of enrollment that would necessitate immediate relief for that patient
History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
History of opportunistic infections (e.g., systemic fungal infections, parasites)
Seropositivity for human immunodeficiency virus (HIV)
Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded.
Pregnancy or lactation
WBC count \<4000/mL or \>14,000/mL
Patients with an history of clinically significant thrombocytopenia, bleeding disorder or a platelet count \<100,000/mL
Seropositivity for hepatitis B or C virus
Patients will undergo testing during screening. Patients who are positive for hepatitis B antigen or hepatitis C antibody will be excluded.
Hepatic enzymes ³3 times the upper limit of normal
History of active tuberculosis (TB) or currently undergoing treatment for TB
Chest X-ray within 3 months of Day 0 is required for all patients. Patients with a positive chest X-ray consistent with TB infection will be excluded.
+16 more criteria

Contact the study team to confirm eligibility.

Study Completion

December 2005

Actual (reported)

Last Updated

November 21, 2016

Record last verified: 2009-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00442650
Data provider: ClinicalTrials.gov
Source updated: 2016-11-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:24 UTC

Locations

CH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations