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Trial record 82 of 2725 for:    Rheumatoid Arthritis

Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis (DALI)

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ClinicalTrials.gov Identifier: NCT01078571
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : October 25, 2011
Last Update Posted : October 28, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Biological: adalimumab (HUMIRA®)
Enrollment 705
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab Treatment
Hide Arm/Group Description Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
Period Title: Overall Study
Started 705
Safety Population 675
Intent-to-treat (ITT) Population 591
Completed 590
Not Completed 115
Reason Not Completed
Adverse Event             36
Lack of effectiveness             36
Reason not reported             21
Withdrawal by Subject             12
Lost to Follow-up             8
Protocol Violation             2
Arm/Group Title Adalimumab (Humira)
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 591
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 591 participants
54.15  (12.43)
[1]
Measure Description: Based on the ITT population minus 5 who did not report their age (586).
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 591 participants
Female 461
Male 127
Gender not reported 3
[1]
Measure Description: Based on the ITT population (591).
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 591 participants
591
[1]
Measure Description: Based on the ITT population (591).
Time from Diagnosis of Rheumatoid Arthritis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 591 participants
8.56  (6.86)
[1]
Measure Description: The number of years since the participant first received a diagnosis of rheumatoid arthritis. Based on the ITT population minus 91 who did not report the time since first diagnosis (500).
Positivity of the Rheumatoid Factor   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 591 participants
Positive for Rheumatoid Factor 460
Negative for Rheumatoid Factor 114
Rheumatoid Factor Results Unknown or Missing 17
[1]
Measure Description: The number of participants testing positive or negative for rheumatoid factor. Based on the ITT population (591).
Previous Rheumatoid Arthritis Treatment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 591 participants
Had previous rheumatoid arthritis treatment 588
No previous rheumatoid arthritis treatment 3
[1]
Measure Description: Whether or not participants had taken medication for rheumatoid arthritis within the last 5 years. Based on the ITT population (591).
1.Primary Outcome
Title Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment
Hide Description The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.
Time Frame Baseline, 1, 4, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the safety population of all participants who took at least 1 dose of adalimumab (675 participants).
Arm/Group Title Adalimumab Treatment
Hide Arm/Group Description:
Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
Overall Number of Participants Analyzed 675
Measure Type: Number
Unit of Measure: Participants
Overall: Experienced a serious adverse event 28
Overall: Experienced a non-serious AE 184
Overall: Discontinued from study due to an AE 36
Incidence: At least 1 AE at Baseline 53
-- Incidence: At least 1 AE at 1 month 49
-- Incidence: At least 1 AE at 4 months 50
-- Incidence: At least 1 AE at 6 months 47
-- Incidence: At least 1 AE at 12 months 51
Incidence: At least 1 SAE at Baseline 4
-- Incidence: At least 1 SAE at 1 month 4
-- Incidence: At least 1 SAE at 4 months 6
-- Incidence: At least 1 SAE at 6 months 6
-- Incidence: At least 1 SAE at 12 months 8
2.Secondary Outcome
Title Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).
Hide Description The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to final is presented.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Mean change from baseline to 12 months included the ITT population of 310 de novo and 281 participants treated greater than 4 months.
Arm/Group Title Adalimumab (De Novo) Adalimumab (Treated for Greater Than 4 Months)
Hide Arm/Group Description:
Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.
Participants who had been taking adalimumab for 4 months or longer.
Overall Number of Participants Analyzed 310 281
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.62  (1.61) 0.21  (1.23)
3.Secondary Outcome
Title Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).
Hide Description The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The percentage reduction of baseline values is presented.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Mean reduction from baseline to 12 months was calculated for the ITT population of 310 de novo and 279 participants treated greater than 4 months.
Arm/Group Title Adalimumab (De Novo) Adalimumab (Treated for Greater Than 4 Months)
Hide Arm/Group Description:
Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.
Participants who had been taking adalimumab for 4 months or longer.
Overall Number of Participants Analyzed 310 279
Mean (Standard Deviation)
Unit of Measure: Percentage reduction
0.28  (0.34) 0.01  (0.42)
4.Secondary Outcome
Title Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.
Hide Description The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.
Time Frame Baseline, 1, 4, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted in the ITT population of 591 participants who had assessments at each time point. The number of de novo participants and participants treated greater than 4 months who were analyzed at each time point are given in parentheses.
Arm/Group Title Adalimumab (De Novo) Adalimumab (Treated for Greater Than 4 Months)
Hide Arm/Group Description:
Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.
Participants who had been taking adalimumab for 4 months or longer.
Overall Number of Participants Analyzed 310 281
Mean (Standard Deviation)
Unit of Measure: Joints
Painful Joints at Baseline (n=310 and n =281) 7.93  (6.31) 2.22  (3.39)
-- At 1 month (n=277 and n=203) 4.11  (5.13) 1.67  (3.07)
-- At 4 months (n=292 and n=271) 2.99  (4.14) 1.76  (2.99)
-- At 6 months (n=269 and n=267) 2.53  (3.42) 1.71  (2.86)
-- At 12 months (n=255 and n=262) 2.46  (3.33) 1.61  (3.03)
Swollen Joints at Baseline (n=310 and n=281) 6.19  (5.01) 1.39  (2.41)
-- At 1 month (n=277 and n= 204) 2.94  (3.89) 1.03  (2.16)
-- At 4 months (n=292 and n=272) 2.33  (3.39) 1.04  (2.10)
-- At 6 months (n=269 and n=266) 2.53  (3.42) 1.00  (2.02)
-- At 12 months (n=255 and n=262) 1.73  (2.83) 0.97  (2.00)
5.Secondary Outcome
Title Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.
Hide Description Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.
Arm/Group Title Adalimumab (De Novo) Adalimumab (Treated for Greater Than 4 Months)
Hide Arm/Group Description:
Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.
Participants who had been taking adalimumab for 4 months or longer.
Overall Number of Participants Analyzed 305 280
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.44  (0.67) 0.05  (0.48)
6.Secondary Outcome
Title Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.
Hide Description Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.
Time Frame Baseline and 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.
Arm/Group Title Adalimumab (De Novo) Adalimumab (Treatment for Greater Than 4 Months)
Hide Arm/Group Description:
Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.
Participants who had been taking adalimumab for 4 months or longer.
Overall Number of Participants Analyzed 297 238
Mean (Standard Deviation)
Unit of Measure: Percentage change
0.25  (0.79) -0.09  (1.54)
7.Secondary Outcome
Title Radiological Evaluation of Rheumatoid Arthritis (RA).
Hide Description Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted in the intent-to-treat population (591 participants total).
Arm/Group Title Adalimumab (De Novo) Adalimumab (Treated for Greater Than 4 Months
Hide Arm/Group Description:
Those participants to whom adalimumab had been prescribed for the first time four months or less before the baseline visit were classified as "de novo" participants.
Participants who had been taking adalimumab for 4 months or longer.
Overall Number of Participants Analyzed 310 281
Measure Type: Number
Unit of Measure: Participant
Total number evaluated or not reported at Baseline 310 281
a) Radiological erosions present 153 156
b) Radiological erosions not present 75 57
c) Radiological erosions unknown 54 50
Total evaluated or not reported at 12 months 310 281
a) Radiological erosions present 58 97
b) Radiological erosions not present 49 45
c) Radiological erosions unknown 135 97
Time Frame All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab.
Adverse Event Reporting Description The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
 
Arm/Group Title Adalimumab Treatment
Hide Arm/Group Description Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
All-Cause Mortality
Adalimumab Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab Treatment
Affected / at Risk (%)
Total   28/675 (4.15%) 
Cardiac disorders   
Acute coronary syndrome  1  1/675 (0.15%) 
Acute myocardial infarction  1  2/675 (0.30%) 
Cardiac failure  1  1/675 (0.15%) 
Pericarditis  1  1/675 (0.15%) 
Gastrointestinal disorders   
Pancreatitis acute  1  1/675 (0.15%) 
General disorders   
Pain  1  1/675 (0.15%) 
Hepatobiliary disorders   
Hypertransaminasaemia  1  1/675 (0.15%) 
Infections and infestations   
Abscess  1  1/675 (0.15%) 
Arthritis bacterial  1  2/675 (0.30%) 
Bacteraemia/listeriosis  1  1/675 (0.15%) 
Diarrhoea/pyrexia/salmonellosis  1  1/675 (0.15%) 
Herpes zoster  1  1/675 (0.15%) 
Lower respiratory tract infection  1  1/675 (0.15%) 
Respiratory tract infection  1  1/675 (0.15%) 
Upper respiratory tract infection  1  1/675 (0.15%) 
Injury, poisoning and procedural complications   
Fracture  1  1/675 (0.15%) 
Radius fracture/sternal fracture  1  1/675 (0.15%) 
Musculoskeletal and connective tissue disorders   
Lupus-like syndrome  1  1/675 (0.15%) 
Sjogren's syndrome  1  1/675 (0.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  1/675 (0.15%) 
Malignant melanoma  1  1/675 (0.15%) 
Ovarian cancer  1  1/675 (0.15%) 
Nervous system disorders   
Cerebrovascular accident  1  1/675 (0.15%) 
Dizziness  1  1/675 (0.15%) 
Psychiatric disorders   
Anxiety  1  1/675 (0.15%) 
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  1/675 (0.15%) 
Pulmonary embolism  1  1/675 (0.15%) 
Skin and subcutaneous tissue disorders   
Cutaneous lupus erythematosus  1  1/675 (0.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Adalimumab Treatment
Affected / at Risk (%)
Total   18/675 (2.67%) 
Infections and infestations   
Respiratory tract infection  1  8/675 (1.19%) 
Urinary tract infection  1  10/675 (1.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01078571     History of Changes
Other Study ID Numbers: P10-077
First Submitted: March 1, 2010
First Posted: March 2, 2010
Results First Submitted: May 27, 2011
Results First Posted: October 25, 2011
Last Update Posted: October 28, 2011