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Sponsored by: |
Merck KGaA |
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Information provided by: | Merck KGaA |
ClinicalTrials.gov Identifier: | NCT00697593 |
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 |
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Chronic Plaque Psoriasis |
Drug: Efalizumab - anti CD11a recombinant human MAb |
Phase IV |
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. |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:
Contact: Canadian Local Medical Information | 905-919-0162 |
Canada, Ontario | |
Probity Medical Research | Recruiting |
City Waterloo, Ontario, Canada, N2J 1C4 | |
Contact: Kim Papp 519-579-9535 |
Study Director: | Nicole Selenko-Gebauer | Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany |
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: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00697593 History of Changes |
Health Authority: | Canada: Health Canada |
Efalizumab Chronic Plaque Psoriasis Transition from systemic therapies on to Efalizumab |
Cyclosporine Skin Diseases Psoriasis |
Methotrexate Cyclosporins Skin Diseases, Papulosquamous |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |