Trial Outcomes & Findings for A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia (NCT NCT01387789)

NCT ID: NCT01387789

Last Updated: 2014-05-05

Results Overview

The Health Assessment Questionnaire - Disability Index (HAQ-DI) 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). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 6 months.

• Recruitment status: COMPLETED
• Target enrollment: 71 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2014-05-05

Participant Flow

Participant milestones

Measure	Scheduled to Start Adalimumab Therapy Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Study STARTED	71
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Scheduled to Start Adalimumab Therapy Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Overall Study Adverse Event	5
Overall Study Lack of Efficacy	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia

Baseline characteristics by cohort

Measure	Scheduled to Start Adalimumab Therapy n=71 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Age, Customized <30 years of age	4 participants n=5 Participants
Age, Customized 30-39 years of age	18 participants n=5 Participants
Age, Customized 40-49 years of age	16 participants n=5 Participants
Age, Customized 50-59 years of age	26 participants n=5 Participants
Age, Customized 60-69 years of age	7 participants n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Malaysia	71 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

The Health Assessment Questionnaire - Disability Index (HAQ-DI) 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). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 6 months.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=71 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months	-0.41 units on a scale Standard Deviation 0.79

PRIMARY outcome

Timeframe: Baseline and 6 months

The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=71 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months	-0.49 centimeters Standard Deviation 0.79

PRIMARY outcome

Timeframe: Baseline and 6 months

The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=71 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months Physical Component Summary	16.06 units on a scale Standard Deviation 23.02
Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months Mental Component Summary	12.30 units on a scale Standard Deviation 18.21

SECONDARY outcome

Timeframe: Baseline and 1 month

The Health Assessment Questionnaire - Disability Index (HAQ-DI) 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). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 1 month.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=71 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month	-0.30 units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: Participants with available data at this time point

The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=70 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month	-0.46 centimeters Standard Deviation 0.51

SECONDARY outcome

Timeframe: Baseline and 1 month

The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=71 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month Physical Component Summary	11.46 units on a scale Standard Deviation 16.50
Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month Mental Component Summary	6.42 units on a scale Standard Deviation 13.56

SECONDARY outcome

Timeframe: Baseline and 3 months

The Health Assessment Questionnaire - Disability Index (HAQ-DI) 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). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 3 months.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=71 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months	-0.38 units on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Participants with available data at this time point

The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=70 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months	-0.48 centimeters Standard Deviation 0.72

SECONDARY outcome

Timeframe: Baseline and 3 months

The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.

Outcome measures

Measure	Scheduled to Start Adalimumab Therapy n=71 Participants Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months Physical Component Summary	14.19 units on a scale Standard Deviation 20.54
Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months Mental Component Summary	8.77 units on a scale Standard Deviation 15.55

Adverse Events

Scheduled to Start Adalimumab Therapy

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Scheduled to Start Adalimumab Therapy n=71 participants at risk Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
Blood and lymphatic system disorders Anemia	2.8% 2/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Cardiac disorders Myocardial infarction	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Ear and labyrinth disorders Vertigo	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
General disorders Pyrexia	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Infections and infestations Bronchopneumonia	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Infections and infestations Gastroenteritis	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Infections and infestations Pneumonia	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Infections and infestations Pulmonary tuberculosis	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Respiratory, thoracic and mediastinal disorders Reflux laryngitis	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Surgical and medical procedures Antibiotic prophylaxis	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.
Vascular disorders Hypotension	1.4% 1/71 • SAEs were collected from the time the physician obtained the patient's informed consent until 30 days or 5 half-lives following the last dose of physician-prescribed treatment, an average of 250 days.

Other adverse events

Adverse event data not reported

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