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A Study Evaluating Infliximab Treatment for Chinese Subjects 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: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to determine the superiority and efficacy of 5mg/kg infliximab induction therapy in patients with moderate to severe plaque-type psoriasis compared with placebo. As described in the title of the trial, placebo is used as a control to the trial drug. 2 groups of eligible patients are separately given trial drug or placebo for treatment, a crossover would be met on week 10. The assessment of efficacy and safety are done in each visit until the 26 week follow up visit, when the trial is complete.


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
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Randomized,Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab in Patients With Moderate to Severe Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Infliximab
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change from baseline in the Psoriasis Area Severity Index (PASI) score at Week 10 [ Time Frame: Baseline and Week 10 visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in Dermatology Life Quality Index (DLQI) at Week 10 and 26 [ Time Frame: week 10 and week 26 after treatment ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: week 10 and week 26 after treatment ] [ Designated as safety issue: Yes ]
  • Efficacy of maintenance therapy of infiliximab at week 26. [ Time Frame: Week 26 visit ] [ Designated as safety issue: No ]
  • Change from baseline in Physician Global Assessment (PGA) score at Week 10 [ Time Frame: week 10 visit ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Infliximab 5mg/kg IV week 0 2 6 14 and 22
 Drug: Infliximab
5mg/kg IV week 0, 2, 6, 14 and 22
Placebo Comparator: 002
Placebo Placebo IV weeks 0 2 6 14 and 22
 Drug: Placebo
Placebo IV weeks 0, 2, 6,14 and 22

Detailed Description:

The primary objective of this study is to determine the safety and efficacy of 5mg/kg infliximab induction therapy in patients with moderate to severe plaque-type psoriasis compared with placebo. Secondary objectives of this study are to assess the efficacy of maintenance infliximab therapy, to assess the effects of infliximab on Dematology Life Quality Index (DLQI) and to assess the safety of infliximab therapy. Adult Chinese patients must have had a diagnosis of plaque-type psoriasis for at least 6 months prior to screening and be candidates for phototherapy or systemic therapy. In addition, patients must have a baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved. The eligible patients will be randomized to infliximab or placebo group at 2:1 ratio. A patient assigned to infliximab treatment will receive 5 mg/kg infliximab intravenous (directly into the vein) infusions at weeks 0, 2, and 6 followed by a maintenance regimen of 5mg/kg infliximab iv every 8 weeks through week 22. Placebo iv infusions will be given at weeks 10, 12, and 16 to maintain the blind. A patient assigned to placebo treatment will receive placebo infusions at weeks 0, 2, 6, 14, and 22. At week 10, patients will be crossover to infliximab therapy (5mg/kg) in a double-blind fashion and receive infliximab at week 10, 12 and 16. Infusions should be given over approximately 2 hours. Infliximab arm: 5mg/kg infliximab iv injection at week 0, 2, 6, 14, 22. Placebo injection at week 10, 12, 16. Placebo arm: placebo at week 0, 2, 6, 14, 22. Infliximab injection at week 10, 12, 16.

  Eligibility

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

Inclusion Criteria:

  • Must be of Chinese ancestry
  • The body weight should be <= 80 kg
  • Have had a diagnosis of plaque-type psoriasis >= 6 months prior to screening (subjects with concurrent psoriatic arthritis [PsA] may be enrolled)
  • Have plaque-type psoriasis covering >=10% of total BSA ,PASI score >=at screening and at the baseline
  • Are considered eligible according to the following TB screening criteria:Have no history of latent or active TB prior to screening: Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination
  • Have had no recent close contact with a person with active TB. Within 1 month prior to the first administration of study agent have a negative tuberculin skin test. Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive
  • Clinical laboratory results without clinically significant abnormalities

Exclusion Criteria:

  • Have nonplaque forms of psoriasis (eg, erythrodermic, guttate, or pustular), or have current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  • Have had previous treatment with infliximab
  • Have received within 3 months prior to first infusion or are expected to receive any live virus or bacterial vaccinations during the trial or up to 3 months after the last infusion
  • Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers
  • Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
  • Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  Contacts and Locations
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. 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
Study First Received: August 5, 2010
Last Updated: October 25, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Plaque-type Psoriasis
Infliximab
Efficacy
Safety

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Infliximab
Dermatologic Agents
 Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013