Trial Outcomes & Findings for A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China (NCT NCT01464021)

NCT ID: NCT01464021

Last Updated: 2014-03-06

Results Overview

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

• Recruitment status: TERMINATED
• Target enrollment: 26 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2014-03-06

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	26
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	13
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	1
Overall Study various	11

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Adalimumab n=26 Participants 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.
Age, Continuous	45.0 years STANDARD_DEVIATION 11.17 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Adalimumab n=13 Participants 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.
Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response	9 participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 26

Population: Participants who received at least one injection of adalimumab and have the necessary clinical data available

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.

Outcome measures

Measure	Adalimumab n=15 Participants 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.
Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR) Week 4, n=15	-34.2 percent change Standard Deviation 18.96
Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR) Week 8, n=12	-38.0 percent change Standard Deviation 28.33
Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR) Week 12, n=13	-42.4 percent change Standard Deviation 25.66
Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR) Week 26, n=3	-62.4 percent change Standard Deviation 26.14

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 26

Population: Participants who received at least one injection of adalimumab and have the necessary clinical data available.

Change in number of tender joints and swollen joints for 28 assessed joints.

Outcome measures

Measure	Adalimumab n=19 Participants 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.
Percent Change From Baseline in Tender and Swollen Joint Counts Week 4 tender joint count, n=19	-47.9 Percent change Standard Deviation 38.64
Percent Change From Baseline in Tender and Swollen Joint Counts Week 8 tender joint count, n= 14	-44.4 Percent change Standard Deviation 69.89
Percent Change From Baseline in Tender and Swollen Joint Counts Week 12 tender joint count, n= 13	-65.0 Percent change Standard Deviation 42.89
Percent Change From Baseline in Tender and Swollen Joint Counts Week 26 tender joint count, n= 4	-93.8 Percent change Standard Deviation 12.50
Percent Change From Baseline in Tender and Swollen Joint Counts Week 4 swollen joint count, n=19	-45.7 Percent change Standard Deviation 39.33
Percent Change From Baseline in Tender and Swollen Joint Counts Week 8 swollen joint count, n=14	-43.9 Percent change Standard Deviation 69.70
Percent Change From Baseline in Tender and Swollen Joint Counts Week 12 swollen joint count, n=13	-56.4 Percent change Standard Deviation 55.75
Percent Change From Baseline in Tender and Swollen Joint Counts Week 26 swollen joint count, n=4	-96.9 Percent change Standard Deviation 6.25

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 26

Population: Participants who received at least one injection of adalimumab and have the necessary clinical data available.

C-reactive protein level in serum (mg/dL)

Outcome measures

Measure	Adalimumab n=13 Participants 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.
Percent Change From Baseline in C-reactive Protein Week 8, n=11	-14.6 percent change Standard Deviation 91.82
Percent Change From Baseline in C-reactive Protein Week 12, n=11	33.7 percent change Standard Deviation 175.17
Percent Change From Baseline in C-reactive Protein Week 26, n=3	-82.3 percent change Standard Deviation 29.23
Percent Change From Baseline in C-reactive Protein Week 4, n=13	206.4 percent change Standard Deviation 808.73

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 26

Population: Participants who received at least one injection of adalimumab and have the necessary clinical data available.

Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation.

Outcome measures

Measure	Adalimumab n=16 Participants 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.
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Week 4, n=16	-50.7 percent change Standard Deviation 29.60
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Week 8, n=12	-48.0 percent change Standard Deviation 35.77
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Week 12, n=13	-46.5 percent change Standard Deviation 42.14
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Week 26, n=3	-68.0 percent change Standard Deviation 35.91

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 26

Population: Participants who received at least one injection of adalimumab and have the necessary clinical data available.

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).

Outcome measures

Measure	Adalimumab n=19 Participants 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.
Percent Change From Baseline in Patient's Global Assessment of Disease Activity Week 4, n=19	-44.8 percent change Standard Deviation 26.70
Percent Change From Baseline in Patient's Global Assessment of Disease Activity Week 8, n=14	-55.5 percent change Standard Deviation 37.91
Percent Change From Baseline in Patient's Global Assessment of Disease Activity Week 12, n=13	-55.8 percent change Standard Deviation 42.69
Percent Change From Baseline in Patient's Global Assessment of Disease Activity Week 26, n=4	-66.0 percent change Standard Deviation 34.35

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 26

Population: Participants who received at least one injection of adalimumab and have the necessary clinical data available.

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).

Outcome measures

Measure	Adalimumab n=19 Participants 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.
Percent Change From Baseline in Patient's Assessment of Pain Week 4, n=19	-48.8 percent change Standard Deviation 28.10
Percent Change From Baseline in Patient's Assessment of Pain Week 8, n=14	-57.9 percent change Standard Deviation 38.01
Percent Change From Baseline in Patient's Assessment of Pain Week 12, n=13	-54.1 percent change Standard Deviation 43.01
Percent Change From Baseline in Patient's Assessment of Pain Week 26, n=4	-67.2 percent change Standard Deviation 34.02

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 26

Population: Participants who received at least one injection of adalimumab and have the necessary clinical data available.

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).

Outcome measures

Measure	Adalimumab n=19 Participants 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.
Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity Week 4, n=19	-45.7 percent change Standard Deviation 27.56
Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity Week 8, n=14	-55.9 percent change Standard Deviation 35.03
Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity Week 12, n=13	-53.3 percent change Standard Deviation 39.04
Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity Week 26, n=4	-63.4 percent change Standard Deviation 32.15

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 26

Population: Participants who received at least one injection of adalimumab and have the necessary clinical data available.

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).

Outcome measures

Measure	Adalimumab n=15 Participants 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.
Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Week 12, n=12	-62.3 percent change Standard Deviation 42.27
Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Week 26, n=3	-97.6 percent change Standard Deviation 4.12
Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Week 4, n=15	-47.7 percent change Standard Deviation 47.24
Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Week 8, n=10	-58.2 percent change Standard Deviation 45.53

Adverse Events

Adalimumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Adalimumab n=26 participants at risk 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.
Infections and infestations Upper Respiratory Tract Infection	3.8% 1/26 • From the time of signing of participant authorization or informed consent until 70 days following the last dose of study adalimumab.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER