Trial Outcomes & Findings for A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent (NCT NCT00336973)

NCT ID: NCT00336973

Last Updated: 2015-07-23

Results Overview

The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 73 participants
• Primary outcome timeframe: Day 84
• Results posted on: 2015-07-23

Participant Flow

Participant milestones

Measure	Efalizumab After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Overall Study STARTED	66
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent

Baseline characteristics by cohort

Measure	Efalizumab n=66 Participants After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Age, Continuous	45.6 years STANDARD_DEVIATION 12.48 • n=93 Participants
Sex: Female, Male Female	24 Participants n=93 Participants
Sex: Female, Male Male	42 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 84

Population: Intent-to-treat (ITT)

The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe

Outcome measures

Measure	Efalizumab n=66 Participants After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)	34.8 percentage Interval 0.235 to 0.476

SECONDARY outcome

Timeframe: Day 168

Population: Intent-to-treat (ITT)

The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe

Outcome measures

Measure	Efalizumab n=66 Participants After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)	31.8 percentage Interval 0.209 to 0.444

SECONDARY outcome

Timeframe: Day 84

Population: Intent-to-treat (ITT)

The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe

Outcome measures

Measure	Efalizumab n=66 Participants After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)	9.1 percentage Interval 0.034 to 0.187

SECONDARY outcome

Timeframe: Day 168

Population: Intent-to-treat (ITT)

The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe

Outcome measures

Measure	Efalizumab n=66 Participants After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)	21.2 percentage Interval 0.121 to 0.33

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications Specialist

Genentech, Inc.

Phone: 800-821-8590

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER