Trial Outcomes & Findings for Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (NCT NCT01117480)
NCT ID: NCT01117480
Last Updated: 2016-02-24
Results Overview
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 the Subject's Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Recruitment status
COMPLETED
Target enrollment
1013 participants
Primary outcome timeframe
Month 0, 6, 12, 18 and 24
Results posted on
2016-02-24
Participant Flow
Participant milestones
| Measure |
Moderate-to-severe Rheumatoid Arthritis
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Overall Study
STARTED
|
1013
|
|
Overall Study
COMPLETED
|
985
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Moderate-to-severe Rheumatoid Arthritis
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Overall Study
Protocol Violation
|
8
|
|
Overall Study
Did Not Start Adalimumab Therapy
|
20
|
Baseline Characteristics
Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA
Baseline characteristics by cohort
| Measure |
Moderate-to-severe Rheumatoid Arthritis
n=985 Participants
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
751 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=5 Participants
|
|
Disease duration
|
10.0 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Disease Activity Score 28 (DAS-28)
|
5.14 units on a scale
STANDARD_DEVIATION 1.60 • n=5 Participants
|
|
Health Assessment Questionnaire (HAQ)
|
1.39 units on a scale
STANDARD_DEVIATION 0.72 • n=5 Participants
|
|
Rheumatoid Arthritis Disease Activity Index (RADAI)
|
5.4 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 0, 6, 12, 18 and 24Population: Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for DAS-28.
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 the Subject's Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Moderate-to-severe Rheumatoid Arthritis
n=921 Participants
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
Month 24
|
16 percentage of participants
|
|
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
Month 0
|
11 percentage of participants
|
|
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
Month 6
|
13 percentage of participants
|
|
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
Month 12
|
16 percentage of participants
|
|
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
Month 18
|
15 percentage of participants
|
SECONDARY outcome
Timeframe: Month 0, 6, 12, 18 and 24Population: Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for HAQ.
Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), 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 zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
Outcome measures
| Measure |
Moderate-to-severe Rheumatoid Arthritis
n=972 Participants
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
Month 18
|
-0.37 units on a scale
Standard Deviation 0.63
|
|
Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
Month 0
|
1.39 units on a scale
Standard Deviation 0.72
|
|
Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
Month 6
|
-0.31 units on a scale
Standard Deviation 0.56
|
|
Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
Month 12
|
-0.34 units on a scale
Standard Deviation 0.61
|
|
Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
Month 24
|
-0.37 units on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Month 0, 6, 12, 18 and 24Population: Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for RADAI.
The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 3 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
Outcome measures
| Measure |
Moderate-to-severe Rheumatoid Arthritis
n=972 Participants
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
Month 18
|
-1.88 units on a scale
Standard Deviation 2.32
|
|
Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
Month 0
|
5.4 units on a scale
Standard Deviation 2.1
|
|
Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
Month 6
|
-1.55 units on a scale
Standard Deviation 2.14
|
|
Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
Month 12
|
-1.77 units on a scale
Standard Deviation 2.30
|
|
Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
Month 24
|
-1.93 units on a scale
Standard Deviation 2.39
|
Adverse Events
Moderate-to-severe Rheumatoid Arthritis
Serious events: 43 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Moderate-to-severe Rheumatoid Arthritis
n=985 participants at risk
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Cardiac disorders
Cardiac disorder
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
2/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
General disorders
Death
|
0.20%
2/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
General disorders
Impaired healing
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
Appendicitis
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
Arthritis infective
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
Herpes zoster
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
Intestinal tuberculosis
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
Pneumonia
|
0.20%
2/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.30%
3/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis bacterial
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiolipoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.30%
3/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuropathy peripheral
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Surgical and medical procedures
Eye operation
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Surgical and medical procedures
Knee operation
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Surgical and medical procedures
Pharyngeal operation
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.10%
1/985 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Information
AbbVie
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