Trial Outcomes & Findings for A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528) (NCT NCT00687362)

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 response 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

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

10 weeks

Results posted on

2017-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab 5 mg/kg Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Overall Study STARTED	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab 5 mg/kg Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab 5 mg/kg n=22 Participants Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Age, Continuous	37.05 years STANDARD_DEVIATION 13.15 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	19 Participants n=93 Participants
Region of Enrollment Middle East	22 participants n=93 Participants

PRIMARY outcome

Timeframe: 10 weeks

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 response 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	Infliximab 5 mg/kg n=22 Participants Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10	16 participants

Adverse Events

Infliximab 5 mg/kg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Infliximab 5 mg/kg n=22 participants at risk Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
Gastrointestinal disorders vomiting	13.6% 3/22 • Number of events 3
General disorders pyrexia	18.2% 4/22 • Number of events 5
Infections and infestations tinea versicolour	13.6% 3/22 • Number of events 3
Respiratory, thoracic and mediastinal disorders cough	13.6% 3/22 • Number of events 3
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	13.6% 3/22 • Number of events 3
Skin and subcutaneous tissue disorders psoriasis	13.6% 3/22 • Number of events 5

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI agrees not to publish/publicly present any interim results of the Study without prior written consent of Sponsor. The PI further agrees to provide 30 days written notice to Sponsor prior to submission for publication/presentation to allow Sponsor to review materials which report any results of the Study. Sponsor shall have the right to review/comment on any presentation, which include editorial rights to ensure protection of confidential information, accuracy, and fair balance.
Publication restrictions are in place

Restriction type: OTHER