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

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00287118
First received: February 2, 2006
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

Phase IIIb, open-label, multi-centre study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered SC for 24 weeks.


Condition Intervention Phase
Candidates for Systemic Therapy for Psoriasis
Drug: efalizumab=Raptiva
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Proportion of patients achieving or maintaining a PGA (Physician Global Assessment) 7 points score, rated Excellent, or Cleared at week 24. [ Time Frame: PGA, PASI, DLQI, PSSI, PPASI to be collected at baseline, weeks 4, 8, 12, and 24 or early termination ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: October 2004
Study Completion Date: October 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: efalizumab=Raptiva
Each patient will receive an initial conditioning dose of 0.7 mg/kg/week followed by 1.0 mg/kg/week study drug during the treatment period, 23 weeks. If four or more consecutive doses have been missed, dosing should resume with the conditioning dose of 0.7 mg/kg and then continue receiving 1mg/kg/week thereafter. Study drug will be administered by SC injection.

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A)In the opinion of the investigator, candidate for systemic therapy for psoriasis could include:
  • Patients with moderate to severe plaque psoriasis defined by PASI >10 and BSA>10-
  • Patients with the following may also be deemed to require systemic therapy in the judgement of the physician:
  • Severe psychosocial disability (in the judgement of the physician),or - Nail psoriasis, or
  • Scalp psoriasis, or
  • Palmar plantar psoriasis etc OR
  • B)Subjects who have completed the CLEAR study IMP 24011 and who wish to continue Raptiva (efalizumab) therapy.
  • Body weight of 120 kg
  • 18 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 up to 3 months after the last dose of Raptiva
  • Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
  • Agreement to participate in the study
  • Signed informed consent
  • Discontinuation of any systemic psoriasis treatment prior to commencement of the study drug. No washout period is required for these agents prior to starting study and receiving first dose of study drug (Raptiva)
  • Discontinuation of all biologic agents (other than Raptiva) 3 months prior to receiving first dose of study drug (Raptiva)
  • Discontinuation of PUVA, UVB treatment 28 days prior to commencement of receiving first dose of study drug.
  • Discontinuation of any investigational drug or treatment 3 months prior to study day 0 or as per washout requirements from previous protocol
  • No vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to first dose of study drug
  • Treatment regimens of b blockers, ACE inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to first dose of study drug (SD 0)

Exclusion Criteria:

  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  • Active rebound of psoriasis during or following discontinuation of the previous Raptiva treatment( PASI >125% from baseline and/or new predominant morphology of psoriasis) when reason was adverse event or lack of efficacy of Raptiva. If it was due to another non drug reason (vaccination , or infection) then the patient can be included in this study.
  • History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
  • 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/L or >14,000/L
  • Patient with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count < 100,000 cells/L
  • Seropositivity for hepatitis B or C virus Patients will undergo testing at screening. Patients who are positive for hepatitis B antigen or hepatitis C antibody will be excluded.
  • Hepatic enzymes> 3 times the upper limit of normal
  • History of active tuberculosis (TB) or currently undergoing treatment for TB within one year prior to study day 0. Chest X-ray (within 3 months prior to SD0) is required for high-risk patients (appendix J). Patients with a positive 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.
  • Diagnosis of hepatic cirrhosis, regardless of cause or severity
  • Serum creatinine >2 times the upper limit of normal
  • Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
  • History of substance abuse within the last 5 years
  • Any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287118

Locations
Switzerland
Medical Information Switzerland
Geneva, Switzerland
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Daiana Licu, M.D. Sponsor GmbH
  More Information

No publications provided

Responsible Party: Mauro Placchi, PhD, Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00287118     History of Changes
Other Study ID Numbers: 25161, CONTROL I Study
Study First Received: February 2, 2006
Last Updated: February 17, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

ClinicalTrials.gov processed this record on July 22, 2014