A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01464021

Enrollment

Registered

2011-11-03

Start date

2011-12-31

Completion date

2012-12-31

Last updated

2014-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Study, prospective, Rheumatoid, Observational study, Arthritis, Adalimumab

Brief summary

A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (RA) in China.

Detailed description

This post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for RA patients using commercially available adalimumab administered subcutaneously (SC). Adalimumab effectiveness will be assessed based on data from clinic visits beginning at Baseline and continuing per standard of care for RA. The primary objective is to evaluate the effectiveness of adalimumab in improving patients' disease activity measured by Disease Activity Score (DAS28) at Week 12. The maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections. The study was terminated due to low enrollment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female patient greater than or equal to 18 years of age with diagnosis of RA (Rheumatoid Arthritis) and no history of chronic arthritis before age 16. 2. Patient meets the requirements for treatment with adalimumab per the local product label. 3. Patient is naïve to adalimumab, and has not used any other immunomodulatory biologic\* DMARD (Disease Modifying Antirheumatic Drugs) in the past 8 weeks before the Baseline visit (\*rituximab may not have been used in the past 104 weeks before the Baseline visit). 4. Patient must be able and willing to provide written authorization (or informed consent where applicable) to disclose and use personal health information and comply with the requirements of this study protocol as well as agree to data being collected by Abbott.

Exclusion criteria

1. Patient is currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the Baseline visit. 2. Prior clinically active TB (tuberculosis): if patient has had prior clinically active TB, there should be documentation that a full course of appropriate anti-TB therapy was completed or an ongoing full course of appropriate anti-TB therapy has been started before initiation of adalimumab in accordance with the local product label; otherwise, the patient will not be eligible to participate in this study. 3. Patient who intends to take less than 6 consecutive (every other week) injections of adalimumab. 4. Patients should not be enrolled if they cannot be treated with adalimumab in accordance with the local product label or if the Investigator determines that they should not be enrolled based on his/her clinical judgment.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response	Week 12	A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1

Secondary

Measure	Time frame	Description
Percent Change From Baseline in Tender and Swollen Joint Counts	Weeks 4, 8, 12, 26	Change in number of tender joints and swollen joints for 28 assessed joints.
Percent Change From Baseline in C-reactive Protein	Weeks 4, 8, 12, 26	C-reactive protein level in serum (mg/dL)
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Weeks 4, 8, 12, 26	Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation.
Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)	Weeks 4, 8, 12, 26	The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \> 5.1 indicates high disease activity, ≤ 5.1 indicates moderate disease activity, ≤ 3.2 indicates low disease activity, and ≤ 2.6 indicates clinical remission.
Percent Change From Baseline in Patient's Assessment of Pain	Weeks 4, 8, 12, 26	A horizontal VAS (100 mm) measure of the participant's assessment of RA pain, where the participant was asked to place a vertical mark on the line to indicate how much pain they have had due to RA in the past week, ranging from 0 mm (no pain) to 100 mm (pain as bad as it could be).
Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity	Weeks 4, 8, 12, 26	A horizontal VAS (100 mm) measure of the physician's global assessment of the participant's current RA disease activity, ranging from 0 mm (very good condition) to 100 mm (very bad condition).
Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)	Weeks 4, 8, 12, 26	The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Percent Change From Baseline in Patient's Global Assessment of Disease Activity	Weeks 4, 8, 12, 26	A horizontal Visual Analog Scale (VAS) (100 mm) measure of the participant's global assessment of RA disease activity, where the participant was asked to place a vertical mark on the line to indicate how well their RA has been within the last 24 hours, ranging from 0 mm (very well) to 100 mm (very poorly).

Countries

China

Participant flow

Participants by arm

Arm	Count
Adalimumab Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.	26
Total	26

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lack of Efficacy	1
Overall Study	Lost to Follow-up	1
Overall Study	various	11
Overall Study	Withdrawal by Subject	13

Baseline characteristics

Characteristic	Adalimumab
Age, Continuous	45.0 years STANDARD_DEVIATION 11.17
Race/Ethnicity, Customized Asian	26 participants
Sex: Female, Male Female	21 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	1 / 26
serious Total, serious adverse events	0 / 26

Outcome results

Primary

Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response

A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1

Time frame: Week 12

Population: Participants who received at least 6 consecutive injections of adalimumab (every other week) and have the necessary clinical data for both the Baseline and the Week 12 visit available.

Arm	Measure	Value (NUMBER)
Adalimumab	Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response	9 participants

Secondary