ChangE From Any Systemic psoriasiS therapY to Raptiva

NCT ID: NCT00697593

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-04-30

Brief Summary

To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.

Conditions

Chronic Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Efalizumab

Group Type: EXPERIMENTAL

Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)

Intervention Type: DRUG

Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.

Interventions

Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)

Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Are at least 18 years old.

2. Have plaque psoriasis with an sPGA score of at least moderate or severe at time of initiation of previous systemic treatment.

3. Are transitioning from methotrexate, cyclosporine, retinoids, PUVA or NBUVB and initiating treatment with Raptiva according to the decision of the investigator and in accordance with the indication and the recommendations of the Raptiva Investigator Brochure, i.e. to which they have failed to respond, have a contraindication to or are intolerant of other systemic therapies.

4. Agree to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.

5. Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care.

6. Women of childbearing potential must use appropriate contraception during treatment and up to the last study visit (safety follow-up visit). For men, it is also mandatory to practice contraception during participation in the trial, as there are no existing data on the effect of Raptiva on spermatogenesis.

7. Discontinuation of any investigational drug or treatment 3 months prior to study start or as per washout requirements from previous protocol.

No primary vaccinations (e.g., tetanus, booster, influenza vaccine) for at least 14 days prior to first dose of study drug.For the purposes of this trial, women of childbearing potential is defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive."

Exclusion Criteria

1. Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:

• Hypersensitivity to Raptiva or to any of the excipients.
• Subjects with history of malignancies.
• History of active tuberculosis (TB) or currently undergoing treatment for TB. Purified Protein Derivative (PPD) testing or chest X-ray is required for high-risk subjects. Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded.
• Subjects with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
• Subjects with immunodeficiencies.

2. Simultaneous participation in another clinical trial.

3. Subjects experiencing a psoriasis exacerbation during screening period.

4. Subjects who have previously been on Raptiva treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the subject can be included in this study.

5. History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).

6. History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia.

7. Hepatic enzyme levels =/>3 times the upper limit of normal or serum creatinine level =/>2 times the upper limit of normal.

8. Pregnant or breast-feeding.

9. Any medical condition (prior or existing) that, in the judgment of the investigator or sponsor, could jeopardize the subject's safety following exposure to study drug.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

Principal Investigators

Nicole Selenko-Gebauer

Role: STUDY_DIRECTOR

Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

Locations

Probity Medical Research

City Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

27809

Identifier Type: -

Identifier Source: org_study_id