18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24Primary· Baseline and Week 24
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-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 ze
Group
Value
95% CI
Participants With RA Receiving Adalimumab
-0.3
-0.9 – 0
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12Secondary· Baseline and Week 12
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-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 ze
Group
Value
95% CI
Participants With RA Receiving Adalimumab
-0.2
-0.9 – 0
Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24Secondary· Baseline, Week 12, and Week 24
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 PCS and MCS scores range from 1-100: higher scores indicate a better state of health and an increase
PCS T-Score Week 12
Group
Value
95% CI
Participants With RA Receiving Adalimumab
6.50
2.07 – 9.36
MCS T-Score Week 12
Group
Value
95% CI
Participants With RA Receiving Adalimumab
0.44
-3.49 – 11.00
PCS T-Score Week 24
Group
Value
95% CI
Participants With RA Receiving Adalimumab
4.90
-2.21 – 11.92
MCS T-Score Week 24
Group
Value
95% CI
Participants With RA Receiving Adalimumab
6.01
0.00 – 13.35
Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) IndexSecondary· Baseline, Week 12, and Week 24
The EQ-5D-3L measures the participant's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which has three response choices. The responses record three levels of severity ('no problems', 'having some or moderate problems', and 'being unable to do/extreme problems') within a particular EQ-5D-3L dimension. In addition, a 20 cm visual analogue scale (VAS) measures the participant's self-rated current health state on a scale from 0-100, fro
Week 12
Group
Value
95% CI
Participants With RA Receiving Adalimumab
0.11
0.07 – 0.26
Week 24
Group
Value
95% CI
Participants With RA Receiving Adalimumab
0.19
0.10 – 0.32
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment ScoreSecondary· Baseline, Week 12, and Week 24
The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the participant's rheumatoid arthritis impair the productivity while working past seven days from visit). Data were calculated using the
Week 12
Group
Value
95% CI
Participants With RA Receiving Adalimumab
-58.4
-90.0 – -16.7
Week 24
Group
Value
95% CI
Participants With RA Receiving Adalimumab
-20.0
-53.3 – 0
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment ScoreSecondary· Baseline, Week 12, and Week 24
The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. Activity impairment was calculated via WPAI question 6, the participant's rating of how much rheumatoid arthritis affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely impacted productivity) / 10 \* 100. Negative values indicate improvement from baseline.
Week 12
Group
Value
95% CI
Participants With RA Receiving Adalimumab
-10.0
-30.0 – -10.0
Week 24
Group
Value
95% CI
Participants With RA Receiving Adalimumab
-20.0
-30.0 – 0.0
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) ScoreSecondary· Baseline, Week 12, and Week 24
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-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 ze
Week 12
Group
Value
95% CI
Participants With RA Receiving Adalimumab
23
Week 24
Group
Value
95% CI
Participants With RA Receiving Adalimumab
20
Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) ScoreSecondary· Baseline, Week 12, and Week 24
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-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 ze
Week 12
Group
Value
95% CI
Participants With RA Receiving Adalimumab
50.0
Week 24
Group
Value
95% CI
Participants With RA Receiving Adalimumab
51.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 13 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02668640.