NCT00256139

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
793

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

November 18, 2005

Last Update Submit

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)
  • 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.

Sponsors & Collaborators

Study Sites (1)

Serono International SA

Geneva, 1202, Switzerland

Location

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

Related Links

MeSH Terms

Interventions

efalizumab

Study Officials

  • Patrick Natta, M.D.

    Sponsor GmbH

    STUDY DIRECTOR

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 1, 2003

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

CH(1)