Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
ChangE From Any Systemic psoriasiS therapY to Raptiva (EASY)
This study is currently recruiting participants.
Verified by EMD Serono, June 2008
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00697593
  Purpose

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.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: Efalizumab - anti CD11a recombinant human MAb
Phase IV

MedlinePlus related topics: Psoriasis
Drug Information available for: Methotrexate Cyclosporin Cyclosporine Efalizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety Study
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 PUVA, NBUVB) to Raptiva 1mg/kg/ Week Therapy.

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • The primary endpoint is safety, and will include all AEs, SAEs, and laboratory data (haematology and biochemistry) and urinalysis at all time points, divided by tapering and previous treatment. [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary endpoint will be the efficacy of Raptiva after 12 weeks therapy, measured as the proportion of subjects who achieve an sPGA assessment of minimal or clear at Week 12 (Day 85). [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 182
Study Start Date: January 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Efalizumab - anti CD11a recombinant human 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. PPD testing or chest X-ray is required for high-risk subjects (see Appendix E). 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 ³3 times the upper limit of normal or serum creatinine level ³2 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697593

Contacts
Contact: Canadian Local Medical Information 905-919-0162

Locations
Canada, Ontario
Probity Medical Research Recruiting
City Waterloo, Ontario, Canada, N2J 1C4
Contact: Kim Papp     519-579-9535        
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Nicole Selenko-Gebauer Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

Responsible Party: Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany ( Maria Koutsopoulou )
Study ID Numbers: 27809
Study First Received: June 11, 2008
Last Updated: June 13, 2008
ClinicalTrials.gov Identifier: NCT00697593  
Health Authority: Canada: Health Canada

Keywords provided by EMD Serono:
Efalizumab
Chronic Plaque Psoriasis
Transition from systemic therapies on to Efalizumab

Study placed in the following topic categories:
Cyclosporine
Skin Diseases
Psoriasis
Methotrexate
Cyclosporins
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 15, 2009