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| Name | Class |
|---|---|
| Scientific Research Institute of Rheumatology, Moscow | UNKNOWN |
| Almedis | INDUSTRY |
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The primary objective of this post-marketing observational study was to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history; current concomitant medications; other relevant medical history) of patients prescribed adalimumab (Humira®) for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) as part of routine clinical care in Russia.
This is a non-interventional, observational study in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exist that characterize patient types and adalimumab administration within the Russian population. Further, it is important to characterize the compliance, acceptability of patient self-injection, tolerability and safety profile of this therapy option with the routine clinical care.
The total follow-up for each participant was planned to be 12 months, with approximately 6 follow-up visits occurring at average intervals of 2-3 months. However, since this was an observational study, follow-up was performed according to routine clinical practice; for 127 participants the follow-up period consisted of more than 12 months and the maximum observation period lasted 18.2 months. Follow-up visits were designated sequential visit numbers (Visit 1-6), regardless of the time point at which they occurred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with RA, PsA and AS | Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) prescribed adalimumab as part of Routine Clinical Care in Russia. |
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| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of Patients Prescribed Adalimumab: Education Level | 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. | Baseline |
| Characteristics of Patients Prescribed Adalimumab: Occupation | Participants were asked to indicate their occupation at the Baseline visit. | Baseline |
| Characteristics of Patients Prescribed Adalimumab: Residence Status | Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit. | Baseline |
| Characteristics of Patients Prescribed Adalimumab: Marital Status | Participants were asked to indicate their marital status at the Baseline visit. | Baseline |
| Characteristics of Patients Prescribed Adalimumab: Disease Severity | Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice. | Baseline |
| Characteristics of Patients Prescribed Adalimumab: Duration of Disease | Duration of disease was defined as the time from diagnosis until study entry. | Baseline |
| Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Acceptability of Self-injections | 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. |
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Inclusion Criteria:
Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
Exclusion Criteria:
The following patients will not be included in the study:
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Patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis prescribed adalimumab as part of Routine Clinical Care in Russia.
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| Name | Affiliation | Role |
|---|---|---|
| Andrey N Strugovschikov, MD | Abbott Russia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 50728 | Belgorod | 308007 | Russia | |||
| Site Ref # / Investigator 50737 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis | Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia. |
| FG001 | Psoriatic Arthritis | Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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.
| Baseline and at each follow-up visit (up to a maximum of 18.2 months). |
| 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. |
| Percentage of Participants With Missed or Delayed Injections | Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days. | For the duration of the study (up to a maximum of 18.2 months). |
| Duration of Treatment With Adalimumab | 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. | For the duration of the study (up to a maximum of 18.2 months). |
| Chelyabinsk |
| 454047 |
| Russia |
| Site Ref # / Investigator 50731 | Izhevsk | 426009 | Russia |
| Site Reference ID/Investigator# 29084 | Kaliningrad | 236000 | Russia |
| Site Reference ID/Investigator# 29163 | Khanty-Mansiysk | 626200 | Russia |
| Site Ref # / Investigator 50746 | Khanty-Mansiysk | 628600 | Russia |
| Site Ref # / Investigator 50736 | Krasnogorsk | 143420 | Russia |
| Site Ref # / Investigator 50727 | Lipetsk | 308036 | Russia |
| Site Ref # / Investigator 50723 | Moscow | 105203 | Russia |
| Site Ref # / Investigator 50725 | Moscow | 105229 | Russia |
| Site Ref # / Investigator 50742 | Moscow | 109451 | Russia |
| Site Ref # / Investigator 50743 | Moscow | 109451 | Russia |
| Site Ref # / Investigator 50724 | Moscow | 115682 | Russia |
| Site Ref # / Investigator 50739 | Moscow | 121356 | Russia |
| Site Ref # / Investigator 50732 | Moscow | 123060 | Russia |
| Site Ref # / Investigator 50738 | Moscow | 123098 | Russia |
| Site Ref # / Investigator 50744 | Moscow | 123308 | Russia |
| Site Reference ID/Investigator# 28989 | Moscow | 125009 | Russia |
| Site Reference ID/Investigator# 28990 | Moscow | 125009 | Russia |
| Site Reference ID/Investigator# 29195 | Moscow | 125009 | Russia |
| Site Reference ID/Investigator# 29482 | Moscow | 125009 | Russia |
| Site Reference ID/Investigator# 29483 | Moscow | 125009 | Russia |
| Site Ref # / Investigator 50740 | Moscow | 127206 | Russia |
| Site Ref # / Investigator 50733 | Moscow | 127473 | Russia |
| Site Ref # / Investigator 50745 | Moscow | 127543 | Russia |
| Site Ref # / Investigator 50741 | Moscow | 127642 | Russia |
| Site Reference ID/Investigator# 28956 | Nizhnevartovsk | 628600 | Russia |
| Site Reference ID/Investigator# 28968 | Perm | 614014 | Russia |
| Site Reference ID/Investigator# 28969 | Perm | 614014 | Russia |
| Site Reference ID/Investigator# 28957 | Saint Petersburg | 190000 | Russia |
| Site Reference ID/Investigator# 28997 | Saint Petersburg | 190000 | Russia |
| Site Reference ID/Investigator# 28999 | Saint Petersburg | 190000 | Russia |
| Site Reference ID/Investigator# 29001 | Saint Petersburg | 190000 | Russia |
| Site Reference ID/Investigator# 32403 | Saint Petersburg | 191015 | Russia |
| Site Ref # / Investigator 50729 | Salekhard | 629001 | Russia |
| Site Reference ID/Investigator# 29008 | Surgut | 628400 | Russia |
| Site Reference ID/Investigator# 32404 | Tula | 300036 | Russia |
| Site Reference ID/Investigator# 29095 | Ulyanovsk | 432000 | Russia |
| Site Ref # / Investigator 50734 | V. Novgorod | 173008 | Russia |
| Site Ref # / Investigator 50730 | Vologda | 160001 | Russia |
| Site Ref # / Investigator 50735 | Voronezh | 394024 | Russia |
| Site Ref # / Investigator 50726 | Voronezh | 394082 | Russia |
| Site Reference ID/Investigator# 6002 | Yekaterinburg | 620000 | Russia |
| FG002 | Ankylosing Spondylitis | Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia. |
| Safety Population |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis | Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia. |
| BG001 | Psoriatic Arthritis | Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia. |
| BG002 | Ankylosing Spondylitis | Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Characteristics of Patients Prescribed Adalimumab: Education Level | 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. | Posted | Number | participants | Baseline |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Characteristics of Patients Prescribed Adalimumab: Occupation | Participants were asked to indicate their occupation at the Baseline visit. | Posted | Number | participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Characteristics of Patients Prescribed Adalimumab: Residence Status | Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit. | Posted | Number | participants | Baseline |
|
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| Secondary | Patient's Acceptability of Self-injections | 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. | 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. | Posted | Number | participants | 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. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Missed or Delayed Injections | Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days. | Safety set; the analysis only includes participants with non-missing data. | Posted | Number | percentage of participants | For the duration of the study (up to a maximum of 18.2 months). |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Characteristics of Patients Prescribed Adalimumab: Marital Status | Participants were asked to indicate their marital status at the Baseline visit. | Posted | Number | participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice. | Safety set. | Posted | Number | participants | Baseline |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Characteristics of Patients Prescribed Adalimumab: Duration of Disease | Duration of disease was defined as the time from diagnosis until study entry. | Safety set | Posted | Median | Full Range | months | Baseline |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | 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. | Safety set | Posted | Number | participants | Baseline and at each follow-up visit (up to a maximum of 18.2 months). |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Treatment With Adalimumab | 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. | Safety set. | Posted | Median | Full Range | weeks | For the duration of the study (up to a maximum of 18.2 months). |
|
|
Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rheumatoid Arthritis | Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia. | 2 | 125 | 9 | 125 | ||
| EG001 | Psoriatic Arthritis | Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia. | 0 | 35 | 0 | 35 | ||
| EG002 | Ankylosing Spondylitis | Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia. | 0 | 91 | 8 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection viral | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
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| Male |
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| University degree |
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| Current university student |
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| Other |
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Participants who were unable to self-inject. |
| OG003 | Missing | Participants for whom acceptability data were not available. |
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