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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:
NCT01177800
First received: August 5, 2010
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Psoriasis
Drug: Placebo
Drug: Infliximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Infliximab in the Treatment of Chinese Subjects With Moderate to Severe Plaque-type Psoriasis

Resource links provided by NLM:


Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:

Primary Outcome Measures:
  • Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI) [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10 [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]
    The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.

  • Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score <= 1 at week 10 were reported.


Other Outcome Measures:
  • Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
    The DLQI is a dermatology-specific QOL instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.

  • Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Baseline up to end of study (Week 26) ] [ Designated as safety issue: Yes ]
    The AE is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); significant disability; congenital (occurred before birth, due to parent's genetic input) anomaly.


Enrollment: 129
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infliximab
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
Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm
Drug: Infliximab
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.
Other Name: Remicade
Experimental: Placebo
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
Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm
Drug: Infliximab
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.
Other Name: Remicade

Detailed Description:

This is a double-blind (neither physician nor participant knows the treatment that the participant receives), multicenter (when more than one hospital or medical school team work on a medical research study) and placebo-controlled study of infliximab in participants with moderate to severe plaque-type psoriasis. All the eligible participants will be randomly assigned to infliximab and placebo groups. The infliximab group will receive 5 milligram per kilogram (mg/kg) infliximab infusions (a fluid or a medicine delivered into a vein by way of a needle) intravenously (into a vein) at Week 0, 2 and 6 in the induction treatment phase followed by maintenance regimen of the intervention every 8 weeks up to 26 weeks. Placebo infusions will also be given at Week 10, 12 and 16. The placebo group will receive placebo infusion at Week 0, 2, 6, 14 and 22. At Week 10, participants in placebo group will then receive infliximab induction therapy. Efficacy of the participants will primarily be evaluated by percentage of participants who achieve a Psoriasis Area and Severity Index 75 (PASI) response at Week 10. Participants' safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177800

Locations
China
Beijing, China
Beijng, China
Dalian, China
Jinan, China
Nanjing, China
Shanghai, China
Xi'An, China
Xian, China
Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial Xian-Janssen Pharmaceutical Ltd.
  More Information

No publications provided

Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01177800     History of Changes
Other Study ID Numbers: CR013804, REMICADEPSO3004
Study First Received: August 5, 2010
Results First Received: June 6, 2013
Last Updated: September 4, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Psoriasis
Infliximab
Remicade

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Antibodies, Monoclonal
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Immunologic Factors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014