Back to resultsStudy of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cyclosporins
Retinoids
Systemic corticosteroids
Methotrexate
Systemic corticosteroids/methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Discontinuation of efalizumab, Managing inflammatory recurrence
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cyclosporin
Retinoids
Systemic corticosteroids
Methotrexate
Systemic corticosteroids/methotrexate
Arm 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.
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.
Outcomes
Primary Outcome Measures
Physician's Global Assessment (PGA) of Change Over Time (Good or Better)
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)
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).
Full Information
NCT ID
NCT01079988
First Posted
March 2, 2010
Last Updated
January 26, 2014
Sponsor
Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01079988
Brief Title
Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence
Official Title
A Phase IV Open Label, Multicentre, Investigational Study of the Therapeutic Options for Subjects Discontinuing Efalizumab Therapy and Experiencing Inflammatory Disease Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Discontinuation of efalizumab, Managing inflammatory recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyclosporin
Arm Type
Experimental
Arm 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.
Arm Title
Retinoids
Arm Type
Experimental
Arm 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.
Arm Title
Systemic corticosteroids
Arm Type
Experimental
Arm 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.
Arm Title
Methotrexate
Arm Type
Experimental
Arm 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.
Arm Title
Systemic corticosteroids/methotrexate
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Cyclosporins
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.
Intervention Type
Drug
Intervention Name(s)
Retinoids
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Systemic corticosteroids
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Systemic corticosteroids/methotrexate
Intervention Description
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 Outcome Measure Information:
Title
Physician's Global Assessment (PGA) of Change Over Time (Good or Better)
Description
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%
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient's Global Psoriasis Assessment (PGPA)
Description
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).
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Natta, MD
Organizational Affiliation
Merck Serono SA
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Learn more about this trial
Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence
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