A Long-Term Efficacy and Safety Study of Infliximab in the Treatment of Moderate to Severe Plaque-type Psoriasis - RESTORE II

Phase 1

• Conditions: Moderate to severe plaque-type psoriasis; MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2005-005367-28-GB
• Lead Sponsor: Schering-Plough Research Institute, a division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-01-09
• Study Start: 2012-02-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

The subject must meet ALL of the criteria listed below for entry: 1. Subjects must have met all inclusion/exclusion criteria in Study P04271. 2. Subjects must have been originally randomized to infliximab in Study P04271. 3. Subjects must have completed the full 26 weeks of Study P04271. 4. Subjects must have remained on infliximab for the full 22 weeks of treatment in Study P04271. 5. Subjects must have achieved an improvement in Psoriasis Area and Severity Index (PASI) score =75% from Baseline of Study P04271 to Week 26 of Study P04271. 6. Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study. 7. Subjects are considered eligible according to the following tuberculosis (TB) criteria: a. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; b. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication. 8. Subjects’ Baseline (Visit 1) clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be within the following parameters: a. Hemoglobin =10 g/dL b. White blood cells =3.5 x 10 9/L c. Neutrophils =1.5 x 10 9/L d. Platelets =100 x 10 9/L e. Serum creatinine <1.5 mg/dL (or <133 µmol/L) f. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase levels as outlined in Table 2 g. Total bilirubin < 2 x upper limit of normal 9. Subjects must be free of any clinically significant disease (other than plaque-type psoriasis or psoriatic arthritis) that would interfere with the study evaluations. 10. Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules. 11. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must continue using such measures until 6 months after receiving the last infusion of study medication. 12. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The subject will be excluded from entry if ANY of the criteria listed below are met: 1. Subjects who have any significant ongoing AEs or AEs from P04271 that would prohibit further treatment with infliximab at the time of entry. 2. Subjects originally randomized to methotrexate or subjects who received methotrexate at any time during their participation in Study P04271. 3. Subjects who have non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular). 4. Subjects who have current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium). 5. Female subjects who are pregnant, nursing, and both men and women who are planning pregnancy during the study period or during the 6 months after receiving of the last infusion of study medication. 6. 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. 7. Subjects who are staff personnel directly involved with this study. 8. Subjects who are family members of the investigational study staff.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective of this trial is to assess the long-term safety of maintenance therapy versus intermittent therapy with infliximab in subjects with moderate to severe plaque-type psoriasis.;Primary end point(s): The primary endpoint is the PASI75 (Psoriasis Area and Severity Index) response rate at Week 128 (PASI75 is defined as the proportion of subjects achieving a =75% improvement in PASI from the original Baseline in Study P04271).;Main Objective: The primary objective of this trial is to assess the efficacy of long-term maintenance therapy versus intermittent therapy with infliximab (5 mg/kg by body weight) in adult subjects (aged 18-75 years) diagnosed with moderate to severe plaque-type psoriasis who have remained on 22 weeks of treatment with infliximab in Study P04271, and completed the full 26 weeks of Study P04271.