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OpenTrials
Completed

NCT Number: NCT01079988

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cyclosporins

Drug

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.

Retinoids

Drug

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.

Systemic corticosteroids

Drug

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.

methotrexate

Drug

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.

Systemic corticosteroids/methotrexate

Drug

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.

Primary outcomes

  1. Physician's Global Assessment (PGA) of Change Over Time (Good or Better)

    Time frame: 12 weeks

    The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline:

    Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74%

Secondary outcomes

  1. Patient's Global Psoriasis Assessment (PGPA)

    Time frame: 12 weeks

    The PGPA consisted of a single self-explanatory item:

    On a scale from 0 to 10, with 0 being no psoriasis and 10 the worst psoriasis that you can imagine, please rate the state of your psoriasis right now.

    Note: Consider only your skin condition and do not consider other aspects that may be related to your psoriasis (such as psoriatic arthritis).

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Phase IV Open Label, Multicentre, Investigational Study of the Therapeutic Options for Subjects Discontinuing Efalizumab Therapy and Experiencing Inflammatory Disease Recurrence

Important dates

Study start
2004
Primary completion
2004
Study completion
2005
First posted
Mar 3, 2010
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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