Clinical trial NCT00697593: ChangE From Any Systemic psoriasiS therapY to Raptiva
Official title: A Phase IV Open Label Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Transitioning From Previous Systemic Antipsoriasis Therapies (Methotrexate, Cyclosporine, Retinoids or Psoralen-Ultraviolet Light A (PUVA), Narrow-Band Ultraviolet Light B (NBUVB) to Raptiva 1mg/kg/ Week Therapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Plaque Psoriasis
Keywords: Efalizumab
Chronic Plaque Psoriasis
Transition from systemic therapies on to Efalizumab
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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

Primary outcomes:
measure: Hematology - Hematocrit
timeFrame: Week 12 / Early Termination
measure: Hematology - Hemoglobin
timeFrame: Week 12 / Early Termination
measure: Hematology - Red Blood Cell Count
timeFrame: Week 12 / Early Termination
measure: Hematology - White Blood Cell Count
timeFrame: Week 12 / Early Termination
measure: Hematology - Neutrophils
timeFrame: Week 12 / Early Termination
measure: Hematology - Eosinophils
timeFrame: Week 12 / Early Termination
measure: Hematology - Basophils
timeFrame: Week 12 / Early Termination
measure: Hematology - Monocytes
timeFrame: Week 12 / Early Termination
measure: Hematology - Lymphocytes
timeFrame: Week 12 / Early Termination
measure: Hematology - Platelet Count
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Sodium
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Potassium
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Creatinine
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Total Bilirubin
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Aspartate Transaminase (AST)
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Alanine Transaminase (ALT)
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Alkaline Phosphatase
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Glutamyl Transferase
timeFrame: Week 12 / Early Termination
measure: Biochemistry - Urea
timeFrame: Week 12 / Early Termination
measure: Biochemistry - C-Reactive Protein (CRP)
timeFrame: Week 12 / Early Termination
measure: Urinalysis - pH
timeFrame: Week 12 / Early Termination
measure: Urinalysis - Protein
timeFrame: Week 12 / Early Termination
measure: Urinalysis - Ketones
timeFrame: Week 12 / Early Termination
measure: Urinalysis - Glucose
timeFrame: Week 12 / Early Termination
measure: Urinalysis - Blood
timeFrame: Week 12 / Early Termination
measure: Urinalysis - Nitrite
timeFrame: Week 12 / Early Termination
measure: Urinalysis - Leukocytes Esterase
timeFrame: Week 12 / Early Termination
measure: Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis
timeFrame: Week 12 / Early Termination
Secondary outcomes:
measure: Static Physician's Global Assessment (sPGA)
timeFrame: 12 Weeks/Early Termination
Other outcomes:
Locations:
city: City Waterloo
country: Canada
facility: Probity Medical Research
state: Ontario
Study officials:
affiliation: Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
name: Nicole Selenko-Gebauer
role: STUDY_DIRECTOR
References: