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Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care

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ClinicalTrials.gov Identifier: NCT01163916
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : December 5, 2012
Last Update Posted : December 7, 2012
Sponsor:
Collaborators:
Scientific Research Institute of Rheumatology, Moscow
Almedis
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Time Perspective: Prospective
Conditions Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Enrollment 252
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia. Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia. Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Period Title: Overall Study
Started 126 35 91
Safety Population 125 [1] 35 91
Completed 96 [2] 31 [2] 71 [2]
Not Completed 30 4 20
Reason Not Completed
Withdrawal by Subject             2             0             2
Adverse Event             2             0             1
Lack of Efficacy             2             0             1
Other             24             4             16
[1]
One patient discontinued prior to receiving treatment with adalimumab due to absence of medication.
[2]
Completed 12-months treatment with adalimumab
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Total
Hide Arm/Group Description Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia. Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia. Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia. Total of all reporting groups
Overall Number of Baseline Participants 126 35 91 252
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 35 participants 91 participants 252 participants
47.0  (13.7) 42.4  (12.6) 36.2  (10.6) 42.5  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 35 participants 91 participants 252 participants
Female
93
  73.8%
18
  51.4%
23
  25.3%
134
  53.2%
Male
33
  26.2%
17
  48.6%
68
  74.7%
118
  46.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russian Federation Number Analyzed 126 participants 35 participants 91 participants 252 participants
126 35 91 252
1.Primary Outcome
Title Characteristics of Patients Prescribed Adalimumab: Education Level
Hide Description Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 126 35 91
Measure Type: Number
Unit of Measure: participants
Secondary school 21 2 5
Vocational school/college 34 9 26
University degree 64 19 51
Current university student 5 5 8
Other 2 0 1
2.Primary Outcome
Title Characteristics of Patients Prescribed Adalimumab: Occupation
Hide Description Participants were asked to indicate their occupation at the Baseline visit.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 126 35 91
Measure Type: Number
Unit of Measure: participants
Blue collar worker 13 5 10
Civil servant 10 5 12
White collar worker 52 13 38
Self-employed 8 1 9
Student 7 4 4
Retired 21 4 4
Other 15 3 14
3.Primary Outcome
Title Characteristics of Patients Prescribed Adalimumab: Residence Status
Hide Description Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 126 35 91
Measure Type: Number
Unit of Measure: participants
Permanent 113 33 88
Temporary 13 2 3
4.Primary Outcome
Title Characteristics of Patients Prescribed Adalimumab: Marital Status
Hide Description Participants were asked to indicate their marital status at the Baseline visit.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 126 35 91
Measure Type: Number
Unit of Measure: participants
Married 94 24 69
Single 32 11 21
Missing 0 0 1
5.Primary Outcome
Title Characteristics of Patients Prescribed Adalimumab: Disease Severity
Hide Description Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set.
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 125 35 91
Measure Type: Number
Unit of Measure: participants
Mild 0 2 0
Moderate 44 14 31
Severe 81 19 60
6.Primary Outcome
Title Characteristics of Patients Prescribed Adalimumab: Duration of Disease
Hide Description Duration of disease was defined as the time from diagnosis until study entry.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 125 35 91
Median (Full Range)
Unit of Measure: months
71.70
(0.1 to 370.4)
103.50
(13.2 to 597.3)
50.90
(0.0 to 376.3)
7.Primary Outcome
Title Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment
Hide Description Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.
Time Frame Baseline and at each follow-up visit (up to a maximum of 18.2 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 125 35 91
Measure Type: Number
Unit of Measure: participants
Methotrexate 96 23 20
NSAIDs 73 16 72
Corticosteroids 48 9 16
Other medications 82 18 65
8.Secondary Outcome
Title Patient's Acceptability of Self-injections
Hide Description

At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were "convenient," "inconvenient" and "unable to self-inject."

The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice.

Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization.

Time Frame Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed (251) represents the total number of participants in the safety set. The number of participants with available data at each follow-up visit were: Visit 1: 249; Visit 2: 246; Visit 3: 237; Visit 4: 205; Visit 5: 179; Visit 6: 135.
Arm/Group Title Convenient Not Convenient Need Assistance Missing
Hide Arm/Group Description:
Participants who described the acceptability of adalimumab injections as "convenient."
Participants who described the acceptability of adalimumab injections as "not convenient."
Participants who were unable to self-inject.
Participants for whom acceptability data were not available.
Overall Number of Participants Analyzed 251 251 251 251
Measure Type: Number
Unit of Measure: participants
Visit 1: 40 mg every other week 168 10 71 0
Visit 1: 40 mg once a week 0 0 0 0
Visit 2: 40 mg every other week 172 7 63 0
Visit 2: 40 mg once a week 1 0 1 0
Visit 2: Missing regimen data 2 0 0 0
Visit 3: 40 mg every other week 177 7 49 0
Visit 3: 40 mg once a week 0 0 0 0
Visit 3: Missing regimen data 4 0 0 0
Visit 4: 40 mg every other week 155 3 45 0
Visit 4: 40 mg once a week 0 0 0 0
Visit 4: Missing regimen data 2 0 0 0
Visit 5: 40 mg every other week 137 1 39 0
Visit 5: 40 mg once a week 0 0 0 0
Visit 5: Missing regimen data 0 0 1 1
Visit 6: 40 mg every other week 105 1 27 0
Visit 6: 40 mg once a week 1 0 0 0
Visit 6: Missing regimen data 0 0 0 1
9.Secondary Outcome
Title Percentage of Participants With Missed or Delayed Injections
Hide Description Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.
Time Frame For the duration of the study (up to a maximum of 18.2 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set; the analysis only includes participants with non-missing data.
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 125 35 90
Measure Type: Number
Unit of Measure: percentage of participants
No missed or delayed injections 55.2 57.1 56.7
One missed or delayed injection 21.6 11.4 21.1
Two missed or delayed injections 9.6 20.0 7.8
Three or more missed or delayed injections 13.6 11.4 14.4
10.Secondary Outcome
Title Duration of Treatment With Adalimumab
Hide Description Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.
Time Frame For the duration of the study (up to a maximum of 18.2 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety set.
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description:
Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Number of Participants Analyzed 125 35 91
Median (Full Range)
Unit of Measure: weeks
52.10
(0.1 to 74.0)
52.90
(25.1 to 81.4)
52.30
(10.3 to 78.0)
Time Frame Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Hide Arm/Group Description Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia. Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia. Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
All-Cause Mortality
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/125 (1.60%)   0/35 (0.00%)   0/91 (0.00%) 
Infections and infestations       
Bacteraemia  1  1/125 (0.80%)  0/35 (0.00%)  0/91 (0.00%) 
Purulent discharge  1  1/125 (0.80%)  0/35 (0.00%)  0/91 (0.00%) 
Injury, poisoning and procedural complications       
Wound necrosis  1  1/125 (0.80%)  0/35 (0.00%)  0/91 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/125 (7.20%)   0/35 (0.00%)   8/91 (8.79%) 
Infections and infestations       
Respiratory tract infection viral  1  9/125 (7.20%)  0/35 (0.00%)  8/91 (8.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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.
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: 800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01163916     History of Changes
Other Study ID Numbers: P10-272
First Submitted: February 26, 2010
First Posted: July 16, 2010
Results First Submitted: November 8, 2012
Results First Posted: December 5, 2012
Last Update Posted: December 7, 2012