Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Drug: Systemic corticosteroids; Drug: Retinoids; Drug: Systemic corticosteroids/methotrexate; Drug: Methotrexate; Drug: Cyclosporins

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079988

25180

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 5 patient groups

Cyclosporin

Experimental group

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.

Treatment:

Drug: Cyclosporins

Retinoids

Experimental group

Description:

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.

Treatment:

Drug: Retinoids

Systemic corticosteroids

Experimental group

Description:

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.

Treatment:

Drug: Systemic corticosteroids

Methotrexate

Experimental group

Description:

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.

Treatment:

Drug: Methotrexate

Systemic corticosteroids/methotrexate

Experimental group

Description:

Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. 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.

Treatment:

Drug: Systemic corticosteroids/methotrexate