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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01079988
First received: March 2, 2010
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Cyclosporins
Drug: Retinoids
Drug: Systemic corticosteroids
Drug: Methotrexate
Drug: Systemic corticosteroids/methotrexate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV Open Label, Multicentre, Investigational Study of the Therapeutic Options for Subjects Discontinuing Efalizumab Therapy and Experiencing Inflammatory Disease Recurrence

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Physician's Global Assessment (PGA) of Change Over Time (Good or Better) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Patient's Global Psoriasis Assessment (PGPA) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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).



Enrollment: 41
Study Start Date: February 2004
Study Completion Date: April 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyclosporin
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.
Drug: Cyclosporins
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.
Experimental: Retinoids
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.
Drug: Retinoids
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.
Experimental: Systemic corticosteroids
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.
Drug: Systemic corticosteroids
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.
Experimental: Methotrexate
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.
Drug: Methotrexate
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.
Experimental: Systemic corticosteroids/methotrexate

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.

Drug: Systemic corticosteroids/methotrexate
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079988

Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Patrick Natta, MD Merck Serono SA
  More Information

Publications:
Papp KA, Toth D, Rosoph L, on behalf of the 25180 study group. Approaches to discontinuing efalizumab: results of an open-label study comparing different transitioning therapies. Abstract for presentation at EADV2005, Sofia, Bulgaria, 19-22 May 2005

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01079988     History of Changes
Other Study ID Numbers: 25180
Study First Received: March 2, 2010
Results First Received: April 12, 2010
Last Updated: January 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by Merck KGaA:
Psoriasis
Discontinuation of efalizumab
Managing inflammatory recurrence

Additional relevant MeSH terms:
Psoriasis
Recurrence
Skin Diseases, Papulosquamous
Skin Diseases
Disease Attributes
Pathologic Processes
Methotrexate
Cyclosporine
Cyclosporins
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014