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

NCT00287118 | Completed Phase 4 Results

• 2 other identifiers: 25161CONTROL I Study
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.

Conditions

Candidates for Systemic Therapy for Psoriasis; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24

  The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.

  Week 24

Study Arms (1)

Efalizumab

EXPERIMENTAL

Drug: Efalizumab

Interventions

Efalizumab DRUG

Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.

Also known as: Raptiva

Efalizumab

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A) In the opinion of the investigator, candidate for systemic therapy for psoriasis could include:
• Patients with moderate to severe plaque psoriasis defined by Psoriasis Area and Severity Index (PASI) less than (\>) 10 and body surface area (BSA) greater than (\>) 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 investigational medicinal product (IMP) 24011 (NCT00256139) and who wish to continue Raptiva (efalizumab) therapy.
• 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 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 ultraviolet (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)

You may not qualify if:

• 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
• White blood cell (WBC) count \<4000 per Liter (L) or \>14,000/L
• Patient with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count \< 00,000 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 Study Day 0) is required for high-risk patients. 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Medical Information Switzerland

Geneva, Switzerland

Location

Related Publications (1)

• Stengel FM, Petri V, Campbell GA, Dorantes GL, Lopez M, Galimberti RL, Valdez RP, de Arruda LF, Guerra MA, Chouela EN, Licu D; International IMP25161 Study Group. Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results. Arch Drug Inf. 2009 Dec;2(4):71-78. doi: 10.1111/j.1753-5174.2009.00024.x.

  PMID: 20098510 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: October 27, 2004
• Primary Completion: May 30, 2006
• Study Completion: May 30, 2006
• Last Updated: April 3, 2018
• Results First Posted: April 3, 2018

Record last verified: 2017-08

Locations

CH (1)