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

NCT03339089 | Completed

• 1 other identifier: P16-828
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 10

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.

Conditions

Ankylosing Spondylitis (AS); Psoriasis; Rheumatoid Arthritis (RA)

Keywords

rheumatoid arthritis; plaque psoriasis; ankylosing spondylitis; Immune-Mediated Inflammatory Diseases; Chinese Patients

Outcome Measures

Primary Outcomes (1)

• Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up 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.

  From Week 0 to Week 24

Secondary Outcomes (13)

• 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 Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Ankylosing spondylitis (AS)

  Up to Week 52

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

  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

Study Arms (3)

Participants with Rheumatoid Arthritis (RA)

This group/ cohort includes participants with RA.

Participants with Plaque Psoriasis (Ps)

This group/ cohort includes participants with Ps.

Participants with Ankylosing spondylitis (AS)

This group/ cohort includes participants with AS.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese participants diagnosed with rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis, for whom adalimumab (Humira®) treatment has already been decided as per local label, will be recruited from within the clinical setting of each rheumatologist or dermatologist participating in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340

Shenzhen, Guangdong, 518040, China

Location

AbbVie China /ID# 164373

Shanghai, Shanghai Municipality, 200041, China

Location

The First affiliated hospital of chengdu medical university /ID# 210745

Chengdu, Sichuan, 610500, China

Location

Zhejiang Province People's Hospital /ID# 209342

Hangzhou, Zhejiang, 310014, China

Location

Sir Run Run Shaw Hospital /ID# 210820

Hangzhou, Zhejiang, 310018, China

Location

The First Hospital of Jiaxing /ID# 213686

Jiaxing, Zhejiang, 314000, China

Location

The Second Hospital of Jiaxing /ID# 210744

Jiaxing, Zhejiang, 314033, China

Location

Jinhua Municipal Central Hospital /ID# 209339

Jinhua, Zhejiang, 321000, China

Location

Sichuan Provincial orthopedic hospital /ID# 209341

Chengdu, 610041, China

Location

West China Hospital, SCU West China School of Medicine, SCU /ID# 209333

Chengdu, 610041, China

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Spondylitis, Ankylosing; Psoriasis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: May 18, 2018
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

CN (10)