NCT00256139

CompletedPhase 3

CLEAR Study: Clinical Experience Acquired With Raptiva Study

Merck KGaA, Darmstadt, Germany Source

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Other study identifiers

Sponsor study identifier

24011

Study Type

interventional

Actual enrollment (reported)

793

Locations

1 country

Sites

1

Timeline

Study Start

March 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2004

Actual (reported)

Study Completion

October 2004

Actual (reported)

Brief Summary

A multicentre, randomised, double blind, placebo controlled phase III study of subcutaneously administered Raptiva in the treatment of patients with moderate to severe psoriasis

Registry Overview

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

Recruitment status: completed
Actual enrollment (reported): 793 participants
Study completion date: October 2004
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

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

Study Start
March 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 2004
Actual (reported)
Study Completion
October 2004
Actual (reported)
First Submitted
November 18, 2005
Actual (reported)
First Posted
November 21, 2005
Actual (reported)

Last Updated: January 16, 2017
Status Verified: January 2017
Last Update Submitted: January 13, 2017

Conditions

Moderate to Severe Psoriasis

Interventions

RaptivaDrug

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 (see Appendix A)

Sponsors & Collaborators

Merck KGaA, Darmstadt, Germany
Industrylead

Study Sites (1)

Serono International SA

Geneva, 1202, Switzerland

Related Publications (2)

Dubertret L, Sterry W, Bos JD, Chimenti S, Shumack S, Larsen CG, Shear NH, Papp KA; CLEAR Multinational Study Group. CLinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a phase III international randomized, placebo-controlled trial. Br J Dermatol. 2006 Jul;155(1):170-81. doi: 10.1111/j.1365-2133.2006.07344.x.
PMID: 16792770RESULT
Ortonne JP, Shear N, Shumack S, Henninger E; CLEAR Multinational Study Group. Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: results of the international, randomized, placebo-controlled Phase III Clinical Experience Acquired with Raptiva (CLEAR) trial [NCT00256139]. BMC Dermatol. 2005 Dec 16;5:13. doi: 10.1186/1471-5945-5-13.
PMID: 16359548DERIVED

MeSH Terms

Interventions

efalizumab

Study Officials

Patrick Natta, M.D.
Sponsor GmbH
STUDY DIRECTOR

Enrollment

793 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 21, 2005

Study Start

March 2003

Date type not reported

This date has not been verified as actual or estimated.

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NCT01237262

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Phase 4Unknown

Diagnosis of psoriasis for at least 6 months

A minimum PASI score of 12.0 at screening (see Appendix A)

Patients who are either not controlled by, intolerant to or contraindicated to at least 2 currently available systemic therapies (e.g., photochemotherapy (PUVA), cyclosporin, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP) (defined as "high need" patients)

Body weight \<= £120 kg

to 75 years old

For women of childbearing potential, 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

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
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
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 PPD testing or chest X-ray is required for high risk patients (see Appendix I). Patients with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded.
Presence of malignancy within the past 5 years, including lymphoproliferative disorders Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
Previous treatment with Raptiva (anti-CD11a)
Diagnosis of hepatic cirrhosis, regardless of cause or severity
Serum creatinine ³2 times the upper limit of normal
+10 more criteria

Contact the study team to confirm eligibility.

Primary Completion

October 2004

Actual (reported)

Study Completion

October 2004

Actual (reported)

Last Updated

January 16, 2017

Record last verified: 2017-01

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00256139
Data provider: ClinicalTrials.gov
Source updated: 2017-01-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:28 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 (2)

Related Links

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations