Trial Outcomes & Findings for A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612) (NCT NCT00687401)

Results Overview

PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

215 participants

Primary outcome timeframe

10 weeks

Results posted on

2017-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab 5 mg/kg Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Overall Study STARTED	159
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab 5 mg/kg Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Overall Study Protocol Violation	7
Overall Study Adverse Event	6
Overall Study Lack of Efficacy	6
Overall Study Withdrawal by Subject	4
Overall Study Did not return for visit	3
Overall Study For reasons different from those above	4

Baseline Characteristics

A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab 5 mg/kg n=159 Participants Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Age, Continuous	44.15 years STANDARD_DEVIATION 12.80 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: Intent to Treat Population (ITT): 159 participants out of the 215 enrolled patients who received at least one dose of the study drug. Per Protocol Population (PP): 138 participants not withdrawn from the study due to major protocol violation and who have received the three infusions of the study drug planned by the protocol.

PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).

Outcome measures

Outcome measures
Measure	Intent to Treat Population n=159 Participants Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).	Per Protocol Population n=138 Participants Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score	111 Participants	111 Participants

Adverse Events

Infliximab 5 mg/kg

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab 5 mg/kg n=159 participants at risk Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Infections and infestations pneumonia legionella	0.63% 1/159 • Number of events 1
Skin and subcutaneous tissue disorders erythema	0.63% 1/159 • Number of events 1

Other adverse events

Other adverse events
Measure	Infliximab 5 mg/kg n=159 participants at risk Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
General disorders pyrexia	5.7% 9/159 • Number of events 10
Musculoskeletal and connective tissue disorders arthralgia	5.0% 8/159 • Number of events 11

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No specific time period restrictions. If the parties disagree concerning the accuracy and appropriateness of the data analysis and presentation, and/or confidentiality of information, the Sponsor and the Investigator will make good faith efforts to resolve any issues or disagreement.
Publication restrictions are in place

Restriction type: OTHER