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Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)

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ClinicalTrials.gov Identifier: NCT01117480
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Moderate-to-severe Rheumatoid Arthritis
Enrollment 1013
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Moderate-to-severe Rheumatoid Arthritis
Hide Arm/Group Description Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
Period Title: Overall Study
Started 1013
Completed 985
Not Completed 28
Reason Not Completed
Protocol Violation             8
Did Not Start Adalimumab Therapy             20
Arm/Group Title Moderate-to-severe Rheumatoid Arthritis
Hide Arm/Group Description Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
Overall Number of Baseline Participants 985
Hide Baseline Analysis Population Description
Baseline analyses accounts for Intention to treat (ITT) population (all participants who received at least 1 dose of study drug).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 985 participants
55.4  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 985 participants
Female
751
  76.2%
Male
234
  23.8%
Disease duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 985 participants
10.0  (9.8)
Disease Activity Score 28 (DAS-28)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 985 participants
5.14  (1.60)
[1]
Measure Description:

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 total of 64 participants had DAS-28 information missing/ unavailable at baseline. These participants were excluded from the efficacy analysis.

Health Assessment Questionnaire (HAQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 985 participants
1.39  (0.72)
[1]
Measure Description:

HAQ-DI is a participant-reported questionnaire 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); which were summed and averaged to provide an overall score ranging from 0 to 3.

A total of 13 participants had HAQ information missing/ unavailable at baseline. These participants were excluded from the efficacy analysis.

Rheumatoid Arthritis Disease Activity Index (RADAI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 985 participants
5.4  (2.1)
[1]
Measure Description:

The RADAI is a questionnaire used for measuring disease activity. The index consists of 6 questions: (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 RADAI total score is the sum of individual items divided by 5 (range 0-10).

A total of 13 participants had RADAI information missing/ unavailable at baseline. These participants were excluded from the efficacy analysis.

1.Primary Outcome
Title Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
Hide Description 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.
Time Frame Month 0, 6, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for DAS-28.
Arm/Group Title Moderate-to-severe Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
Overall Number of Participants Analyzed 921
Measure Type: Number
Unit of Measure: percentage of participants
Month 0 11
Month 6 13
Month 12 16
Month 18 15
Month 24 16
2.Secondary Outcome
Title Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
Hide Description 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.
Time Frame Month 0, 6, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for HAQ.
Arm/Group Title Moderate-to-severe Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
Overall Number of Participants Analyzed 972
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 0 1.39  (0.72)
Month 6 -0.31  (0.56)
Month 12 -0.34  (0.61)
Month 18 -0.37  (0.63)
Month 24 -0.37  (0.65)
3.Secondary Outcome
Title Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
Hide Description 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.
Time Frame Month 0, 6, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for RADAI.
Arm/Group Title Moderate-to-severe Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
Overall Number of Participants Analyzed 972
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 0 5.4  (2.1)
Month 6 -1.55  (2.14)
Month 12 -1.77  (2.30)
Month 18 -1.88  (2.32)
Month 24 -1.93  (2.39)
Time Frame 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.
Adverse Event Reporting Description Non serious adverse events were not collected for this study.
 
Arm/Group Title Moderate-to-severe Rheumatoid Arthritis
Hide Arm/Group Description Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
All-Cause Mortality
Moderate-to-severe Rheumatoid Arthritis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Moderate-to-severe Rheumatoid Arthritis
Affected / at Risk (%)
Total   43/985 (4.37%) 
Blood and lymphatic system disorders   
Leukopenia  1  1/985 (0.10%) 
Cardiac disorders   
Cardiac disorder  1  1/985 (0.10%) 
Myocardial infarction  1  2/985 (0.20%) 
Gastrointestinal disorders   
Gastric ulcer perforation  1  1/985 (0.10%) 
Pancreatitis  1  1/985 (0.10%) 
Small intestinal obstruction  1  1/985 (0.10%) 
General disorders   
Death  1  2/985 (0.20%) 
Impaired healing  1  1/985 (0.10%) 
Infections and infestations   
Appendicitis  1  1/985 (0.10%) 
Arthritis infective  1  1/985 (0.10%) 
Escherichia urinary tract infection  1  1/985 (0.10%) 
Herpes zoster  1  1/985 (0.10%) 
Intestinal tuberculosis  1  1/985 (0.10%) 
Pneumonia  1  2/985 (0.20%) 
Staphylococcal sepsis  1  1/985 (0.10%) 
Injury, poisoning and procedural complications   
Fall  1  3/985 (0.30%) 
Musculoskeletal and connective tissue disorders   
Arthritis bacterial  1  1/985 (0.10%) 
Intervertebral disc degeneration  1  1/985 (0.10%) 
Joint effusion  1  1/985 (0.10%) 
Lupus-like syndrome  1  1/985 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma  1  1/985 (0.10%) 
Adenocarcinoma of colon  1  1/985 (0.10%) 
Angiolipoma  1  1/985 (0.10%) 
Basal cell carcinoma  1  1/985 (0.10%) 
Bladder cancer  1  1/985 (0.10%) 
Bladder transitional cell carcinoma  1  1/985 (0.10%) 
Colon cancer metastatic  1  1/985 (0.10%) 
Diffuse large B-cell lymphoma  1  1/985 (0.10%) 
Endometrial adenocarcinoma  1  1/985 (0.10%) 
Invasive breast carcinoma  1  1/985 (0.10%) 
Lentigo maligna  1  1/985 (0.10%) 
Lung adenocarcinoma  1  1/985 (0.10%) 
Neoplasm malignant  1  3/985 (0.30%) 
Non-Hodgkin's lymphoma  1  1/985 (0.10%) 
Pharyngeal cancer  1  1/985 (0.10%) 
Small cell carcinoma  1  1/985 (0.10%) 
Thyroid cancer  1  1/985 (0.10%) 
Neuropathy peripheral  1  1/985 (0.10%) 
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  1/985 (0.10%) 
Pneumothorax  1  1/985 (0.10%) 
Skin and subcutaneous tissue disorders   
Stevens-Johnson syndrome  1  1/985 (0.10%) 
Surgical and medical procedures   
Cholecystectomy  1  1/985 (0.10%) 
Coronary artery bypass  1  1/985 (0.10%) 
Eye operation  1  1/985 (0.10%) 
Joint arthroplasty  1  1/985 (0.10%) 
Knee operation  1  1/985 (0.10%) 
Pharyngeal operation  1  1/985 (0.10%) 
Spinal fusion surgery  1  1/985 (0.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Moderate-to-severe Rheumatoid Arthritis
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Information
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01117480     History of Changes
Other Study ID Numbers: PMOS-CANA-04-01
First Submitted: May 4, 2010
First Posted: May 5, 2010
Results First Submitted: December 11, 2015
Results First Posted: February 24, 2016
Last Update Posted: February 24, 2016