Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)

Psoriasis Clinical Trial

— DOSE  

Official title:

A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00833053
• Other study ID #: P05315
• Secondary ID: EUDRACT: 2008-00
• Status: Terminated
• Phase: Phase 3
• First received: January 29, 2009
• Last updated: August 13, 2015
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.

• Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319

• Subjects must be at least 18 years old

• Subjects must be candidates for phototherapy or systemic treatment for psoriasis.

• Subjects must not be pregnant and must meet contraceptive requirements

• Subjects must meet tuberculosis screening criteria

• Subjects must meet laboratory and medical history screening requirements

Exclusion Criteria:

• Subjects for whom infliximab or methotrexate is contraindicated or not recommended.

• Subjects already using certain investigational, biological, or immunosuppressive drugs

• Subjects with certain comorbid conditions

• Subjects who currently have or have a history of certain infections

• Subjects who have recently received live virus or bacterial vaccinations

• Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Infliximab
Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
• Infliximab and methotrexate
Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28	The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.	Baseline, Week 28	No
Secondary	Number of Participants With A PASI-50 Response at Week 28	The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.	Baseline, Week 28	No
Secondary	Number of Participants With A PASI-90 Response at Week 28	The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.	Baseline, Week 28	No
Secondary	Number of Participants With A PASI-100 Response at Week 28	The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.	Baseline, Week 28	No
Secondary	Change From Baseline in Mean Participant Raw PASI Scores at Week 28	The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.	Baseline, Week 28	No
Secondary	Dermatology Life Quality Index (DLQI) at Week 28	The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.	Week 28	No
Secondary	Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28	The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.	Baseline, Week 28	No