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Completed

NCT Number: NCT03339089

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

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.

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Key information

Conditions

Ankylosing Spondylitis (AS) Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Rheumatic Diseases Rheumatoid Arthritis (RA) Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340, Shenzhen, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Assessing drug persistence

    Time frame: Up to Week 52

    This is measured using drug survival rate.

  2. Change from baseline in Healthcare Resource Utilization (HCRU)

    Time frame: From Week 0 to Week 52

    This is assessed using the HCRU questionnaire.

  3. Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Ankylosing spondylitis (AS)

    Time frame: Up to Week 52

    WPAI questionnaire will be used to measure work absenteeism, work presenteeism, and daily activity impairment.

  4. Change from Baseline in Dermatology Life Quality Index (DLQI) in participants with Psoriasis (Ps)

    Time frame: Up to Week 52

    The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool in psoriasis clinical research.

  5. Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Rheumatoid Arthritis (RA)

    Time frame: Up to Week 52

    WPAI questionnaire will be used to measure work absenteeism, work presenteeism, and daily activity impairment.

  6. Change from baseline in Clinical Disease Activity Index (CDAI) in participants with Rheumatoid Arthritis (RA)

    Time frame: Up to Week 52

    The CDAI is used to evaluate disease activity.

  7. Percentage of participants achieving low disease activity (CDAI 2.8-10) in participants with Rheumatoid Arthritis (RA)

    Time frame: Up to Week 52

    The CDAI is used to evaluate disease activity.

  8. Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with Ankylosing spondylitis (AS)

    Time frame: Up to Week 52

    BASDAI score is determined using a simple, self-reported questionnaire.

  9. Percentage of participants achieving remission (CDAI<=2.8) in participants with Rheumatoid Arthritis (RA)

    Time frame: Up to Week 52

    The CDAI is used to evaluate disease activity.

  10. Change from baseline in EQ-5D Visual analog scale (VAS)

    Time frame: From Week 0 to Week 52

    It is a patient-reported outcome (PRO) questionnaires used to assess quality of life (QoL).

  11. Change from baseline in EQ-5D index score up to Week 52

    Time frame: From Week 0 to Week 52

    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.

  12. Proportion of participants achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in participants with Ankylosing spondylitis (AS)

    Time frame: Up to Week 52

    BASDAI score is determined using a simple, self-reported questionnaire.

  13. Change from baseline in Psoriasis Area and Severity Index (PASI) in participants with Psoriasis (Ps)

    Time frame: Up to Week 52

    PASI provides a quantitative assessment of psoriasis disease state.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Acronym: ADMIT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2017
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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