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Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( Abbott (China) )
ClinicalTrials.gov Identifier:
NCT01646073
First received: July 18, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

A study to evaluate the safety and efficacy of treatment in Chinese subjects with moderate to severe plaque psoriasis.


Condition Intervention Phase
Plaque Psoriasis
 Biological: Adalimumab
Biological: placebo
 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, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects With Moderate to Severe Plaque Psoriasis

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of subjects achieving improvement in Psoriasis Area and Severity Index [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Proportion of subjects achieving at least a 75% improvement in PASI at Week 12 relative to Baseline.


Secondary Outcome Measures:
  • Proportion of subjects achieving improvement in Psoriasis Area Severity Index [ Time Frame: Weeks 0 up to Week 24, excluding Week 12 ] [ Designated as safety issue: No ]
    Proportion of subjects achieving Psoriasis Area Severity Index 75 response at visits other than Week 12.

  • Change from baseline in Psoriasis Area Severity Index [ Time Frame: Weeks 0 up to Week 24 ] [ Designated as safety issue: No ]
    Subjects with a change in Psoriasis Area Severity Index since their Baseline visit.

  • Proportion of subjects achieving improvement in Physician Global Assessment [ Time Frame: Week 0 up to Week 24 ] [ Designated as safety issue: No ]
    Proportion of subject achieving a clear improvement in Physician Global Assessment


Estimated Enrollment: 420
Study Start Date: July 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adalimumab every other week (eow)
adalimumab eow
 Biological: Adalimumab
adalimumab eow
Other Name: ABT-D2E7, Humira
Placebo Comparator: Placebo
placebo
 Biological: placebo
placebo

Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subject greater than or equal to 18 years of age.
  • Clinical diagnosis of psoriasis for at least 6 months.
  • Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
  • Subject must be willing to receive subcutaneous injections.
  • Subject must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.

Exclusion Criteria:

  • Diagnosis of other active skin diseases or skin infections.
  • Subject has known hypersensitivity to adalimumab or it excipients.
  • Subject has chronic recurring infections or active TB.
  • Subject has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
  • Subject is known to have immune deficiency or is immunocompromised.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646073

Locations
China
Site Reference ID/Investigator# 72873
Beijing, China, 100044
Site Reference ID/Investigator# 72888
Beijing, China, 100034
Site Reference ID/Investigator# 72887
Beijing, China, 100730
Site Reference ID/Investigator# 85693
Chengdu, China, 610072
Site Reference ID/Investigator# 72976
Chongqing, China, 400038
Site Reference ID/Investigator# 72880
Dalian, China, 116011
Site Reference ID/Investigator# 72973
Guangzhou, China, 510120
Site Reference ID/Investigator# 72974
Guangzhou, China, 510630
Site Reference ID/Investigator# 72878
Hangzhou, Zhejiang, China, 310003
Site Reference ID/Investigator# 72877
Hangzhou, Zhejiang, China, 310009
Site Reference ID/Investigator# 87058
Jinan, China, 250012
Site Reference ID/Investigator# 72876
Shanghai, China, 200025
Site Reference ID/Investigator# 72875
Shanghai, China, 200433
Site Reference ID/Investigator# 72883
Shenyang, China, 110001
Site Reference ID/Investigator# 72977
Wuhan, Hubei, China, 430022
Site Reference ID/Investigator# 72975
Xi'an, China, 710032
Sponsors and Collaborators
Abbott (China)
Investigators
Study Chair: Martin Okun, MD Abbott
  More Information

No publications provided

Responsible Party: AbbVie ( Abbott (China) )
ClinicalTrials.gov Identifier: NCT01646073     History of Changes
Other Study ID Numbers: M13-606
Study First Received: July 18, 2012
Last Updated: May 9, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by AbbVie:
Plaque Psoriasis
Psoriasis
Placebo Controlled
Skin Disease
Double Blind

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

ClinicalTrials.gov processed this record on May 16, 2013