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

NCT ID: NCT03339089

Last Updated: 2022-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-18

Study Completion Date

2021-07-08

Brief Summary

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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.

Detailed Description

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Conditions

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Ankylosing Spondylitis (AS) Psoriasis Rheumatoid Arthritis (RA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Rheumatoid Arthritis (RA)

This group/ cohort includes participants with RA.

No interventions assigned to this group

Participants with Plaque Psoriasis (Ps)

This group/ cohort includes participants with Ps.

No interventions assigned to this group

Participants with Ankylosing spondylitis (AS)

This group/ cohort includes participants with AS.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340

Shenzhen, Guangdong, China

Site Status

AbbVie China /ID# 164373

Shanghai, Shanghai Municipality, China

Site Status

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

Chengdu, Sichuan, China

Site Status

Zhejiang Province People's Hospital /ID# 209342

Hangzhou, Zhejiang, China

Site Status

Sir Run Run Shaw Hospital /ID# 210820

Hangzhou, Zhejiang, China

Site Status

The First Hospital of Jiaxing /ID# 213686

Jiaxing, Zhejiang, China

Site Status

The Second Hospital of Jiaxing /ID# 210744

Jiaxing, Zhejiang, China

Site Status

Jinhua Municipal Central Hospital /ID# 209339

Jinhua, Zhejiang, China

Site Status

Sichuan Provincial orthopedic hospital /ID# 209341

Chengdu, , China

Site Status

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

Chengdu, , China

Site Status

Countries

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China

Related Links

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Other Identifiers

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P16-828

Identifier Type: -

Identifier Source: org_study_id

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