Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence
Condition: Psoriasis
MeSH terms: Psoriasis; Recurrence
Intervention: Cyclosporins; Retinoids; Systemic corticosteroids; Methotrexate; Systemic corticosteroids/methotrexate
Intervention description: Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.; Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.; Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.; Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.; Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.
Intervention MeSH terms: Cyclosporine; Methotrexate; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Healthy volunteers: No
Keywords: Psoriasis; Discontinuation of efalizumab; Managing inflammatory recurrence

Summary:

      This is a pilot investigational study of the appropriate therapeutic regimens to treat
      subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon
      discontinuation of efalizumab therapy and of the biological mechanisms involved in
      inflammatory disease recurrence and control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in Genentech study ACD2601g, Genentech study HUPA 600 or Serono study
             IMP24011.

          -  Inflammatory psoriasis disease recurrence occurring up to 2 months after
             discontinuation of efalizumab that required immediate therapeutic control in the
             opinion of the Investigator. Psoriasis had to be rapidly developing, symptomatic and
             inflammatory in nature.

          -  Written informed consent, given prior to any study-related procedure not part of the
             subject's normal medical care, with the understanding that the subject could withdraw
             consent at any time without prejudice to his or her future medical care.

          -  Female subjects had to be neither pregnant nor breast-feeding, and had to lack
             childbearing potential, as defined by either:

               -  Being post-menopausal or surgically sterile, or

               -  Using an accepted form of contraception.

          -  Confirmation that the subject was not pregnant had to be established by a negative
             urinary hCG test at SD1. A pregnancy test was not required if the subject was
             post-menopausal or surgically sterile.

          -  Outpatient status at the time of enrolment.

        Exclusion Criteria:

          -  Disease recurrence that was part of the natural disease progression, was not
             inflammatory in nature, and was not related to efalizumab study medication in the
             previous study.