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Clinical Trials/NCT03339089
NCT03339089CompletedNot Applicable

Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases

AbbVie10 sites in 1 country224 target enrollmentStarted: May 18, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
224
Locations
10
Primary Endpoint
Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participants with a diagnosis of rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis
  • •Decision to initiate Humira® treatment in accordance with routine medical practice and in compliance with eligibility for adalimumab based on the local label
  • •Prior to any study-specific procedures, participant has voluntarily signed the authorization (or informed consent where applicable) to disclose and use anonymized personal health information after participate in this research.

Exclusion Criteria

  • •Inadequate response to previous standard treatment with anti-tumor necrosis factor (TNF) biological agent according to the physician's clinical judgment.
  • •Participant has been treated with adalimumab within 70 days (five half-lives) prior to the Baseline Visit.
  • •Participants discontinued due to adverse drug reaction of previous adalimumab treatment.
  • •Participants who fulfill any of the contraindications as per adalimumab label in China.
  • •Participants, who in the clinician's view, may not be able to comply with the study requirements.

Outcomes

Primary Outcomes

Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24

Time Frame: From Week 0 to Week 24

The European quality of life-5 dimensions (EQ-5D) is a simple, easy to administer, standardized and self-report instrument for health status, which is applicable to a wide range of health conditions and treatment.

Secondary Outcomes

  • Change from Baseline in Dermatology Life Quality Index (DLQI) in participants with Psoriasis (Ps)(Up to Week 52)
  • Change from baseline in Clinical Disease Activity Index (CDAI) in participants with Rheumatoid Arthritis (RA)(Up to Week 52)
  • Assessing drug persistence(Up to Week 52)
  • Change from baseline in Healthcare Resource Utilization (HCRU)(From Week 0 to Week 52)
  • Change from baseline in EQ-5D Visual analog scale (VAS)(From Week 0 to Week 52)
  • Change from baseline in Psoriasis Area and Severity Index (PASI) in participants with Psoriasis (Ps)(Up to Week 52)
  • Proportion of participants achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in participants with Ankylosing spondylitis (AS)(Up to Week 52)
  • Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Rheumatoid Arthritis (RA)(Up to Week 52)
  • Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with Ankylosing spondylitis (AS)(Up to Week 52)
  • Change from baseline in EQ-5D index score up to Week 52(From Week 0 to Week 52)
  • Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Ankylosing spondylitis (AS)(Up to Week 52)
  • Percentage of participants achieving remission (CDAI<=2.8) in participants with Rheumatoid Arthritis (RA)(Up to Week 52)
  • Percentage of participants achieving low disease activity (CDAI 2.8-10) in participants with Rheumatoid Arthritis (RA)(Up to Week 52)

Investigators

Sponsor
AbbVie
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (10)

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