Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2018-08-13

Brief Summary

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The objective of this study was to assess the effectiveness of adalimumab on health and disability outcomes in participants with rheumatoid arthritis (RA) in China.

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Detailed Description

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This was a prospective, multicenter, observational study to assess the effectiveness of adalimumab on health-related quality of life (QoL) and work productivity in participants with rheumatoid arthritis (RA) in routine clinical practice in China. The decision to prescribe adalimumab for RA was based on clinical practice criteria without taking participation in this study into account. Participants were included in the study after a physician's decision of initiating adalimumab treatment. Participants were followed for 24 weeks, with scheduled study visits at baseline, Week 12 and Week 24.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with RA receiving adalimumab

40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks

Adalimumab

Intervention Type BIOLOGICAL

Pre-filled syringe, administered by subcutaneous injection

Interventions

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Adalimumab

Pre-filled syringe, administered by subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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Humira ABT-D2E7

Eligibility Criteria

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Inclusion Criteria

* Participant had a diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis)
* Participants with moderate to severe RA defined as a Disease Activity Score in 28 Joints (DAS28) Erythrocyte Sedimentation Rate (ESR) or DAS28 C-Reactive Protein (CRP) score \>3.2
* Biologically treatment naïve and initiated adalimumab at baseline visit, as per standard daily clinical practice
* Availability of clinical data of the previous 12 weeks prior to baseline
* Ability to self-complete participant questionnaires.
* Participants had signed the authorization (or informed consent where applicable) to disclose and use personal health information after having been prescribed adalimumab

Exclusion Criteria

* Participants who were pregnant or breastfeeding at enrollment or wished to become pregnant in the next 24 weeks.
* Participation in any RA-related clinical trial at the time of enrollment, at baseline, or at any point during the past 24 weeks prior to baseline
* Participants, who in the clinician's view, may not have been able to accurately report their quality of life (QoL) or prior resource utilization
* Participants, who in the clinician's view, may not have been able to adhere to adalimumab therapy over 24 weeks

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No