A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis

NCT01177800 | Completed Phase 3 Results

• 2 other identifiers: CR013804REMICADEPSO3004
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine the superiority and efficacy of infliximab induction therapy in chinese participants with moderate to severe plaque-type psoriasis (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial).

Conditions

Psoriasis

Keywords

Psoriasis; Infliximab; Remicade

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI)

  The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.

  Week 10

Secondary Outcomes (2)

• Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10

  Baseline and Week 10

• Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10

  Week 10

Other Outcomes (2)

• Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26

  Baseline and Week 26

• Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

  Baseline up to end of study (Week 26)

Study Arms (2)

Infliximab

EXPERIMENTAL

5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab will be given at Week 10, 12 and 16. Total duration of treatment will be 26 weeks.

Drug: Placebo; Drug: Infliximab

Placebo

EXPERIMENTAL

Placebo infusion, matched to infliximab will be given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants will receive 5 mg/kg infliximab intravenously. Placebo infusion will be again given at Week 14 and 22. Total duration of treatment will be 26 weeks.

Drug: Placebo; Drug: Infliximab

Interventions

Placebo DRUG

Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm

Infliximab; Placebo

Infliximab DRUG

5 mg/kg infusion given intravenously at Week 0,2,6 (induction treatment phase) and at Week 14 and 22 in maintenance phase in infliximab arm and at Week 12 and 16 in Placebo arm.

Also known as: Remicade

Infliximab; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The body weight should be less than or equal to 80 kilogram
• Participants who had a diagnosis of plaque-type psoriasis (scaly skin rash) greater than or equal to 6 months before Screening (participants with concurrent psoriatic arthritis \[joint pain\] may be enrolled)
• Participants who had plaque-type psoriasis covering greater than or equal to 10 percent of total body surface area, Psoriasis Area Severity Index (PASI) score greater than or equal to 12 at Screening and at the Baseline
• Participants who are candidates for systemic treatment of psoriasis
• Females of childbearing potential and all men must be using adequate birth control measures and agree to use these measures and should not become pregnant (carrying an unborn baby) or plan to become pregnant up to 6 months after receiving last infusion of study drug

You may not qualify if:

• Participants who have nonplaque forms of psoriasis ( for example, erythrodermic, guttate, or pustular), or have current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Participants who are pregnant, nursing or planning to become pregnant within one year while enrolled in the study
• Participants who had previous treatment with infliximab
• Participants who have received agents targeted at reducing tumour necrosis factor or any biologic treatment within the previous 3 months
• Participants who have used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent, whichever is longer

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (7)

Unknown Facility

Beijing, China

Location

Unknown Facility

Beijng, China

Location

Unknown Facility

Dalian, China

Location

Unknown Facility

Jinan, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Xi'an, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Therapeutic Area Physician
• Organization: Beijing, China R&D

+86 010 58218358

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 9, 2010
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 12, 2014
• Results First Posted: March 17, 2014

Record last verified: 2014-09

Locations

CN (7)