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 |
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Recruitment Status :
Completed
First Posted : July 16, 2010
Results First Posted : December 5, 2012
Last Update Posted : December 7, 2012
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| Condition or disease |
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| Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis |
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.
| Study Type : | Observational |
| Actual Enrollment : | 252 participants |
| Time Perspective: | Prospective |
| Official Title: | A Multi-Center Post Marketing Observational Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed HUMIRA® (Adalimumab) as Part of Routine Clinical Care in Russia |
| Study Start Date : | January 2008 |
| Actual Primary Completion Date : | November 2011 |
| Actual Study Completion Date : | November 2011 |
| Group/Cohort |
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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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- Characteristics of Patients Prescribed Adalimumab: Education Level [ Time Frame: Baseline ]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.
- Characteristics of Patients Prescribed Adalimumab: Occupation [ Time Frame: Baseline ]Participants were asked to indicate their occupation at the Baseline visit.
- Characteristics of Patients Prescribed Adalimumab: Residence Status [ Time Frame: Baseline ]Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
- Characteristics of Patients Prescribed Adalimumab: Marital Status [ Time Frame: Baseline ]Participants were asked to indicate their marital status at the Baseline visit.
- Characteristics of Patients Prescribed Adalimumab: Disease Severity [ Time Frame: Baseline ]Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
- Characteristics of Patients Prescribed Adalimumab: Duration of Disease [ Time Frame: Baseline ]Duration of disease was defined as the time from diagnosis until study entry.
- Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment [ Time Frame: Baseline and at each follow-up visit (up to a maximum of 18.2 months). ]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.
- Patient's Acceptability of Self-injections [ 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. ]
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.
- Percentage of Participants With Missed or Delayed Injections [ Time Frame: For the duration of the study (up to a maximum of 18.2 months). ]Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.
- Duration of Treatment With Adalimumab [ Time Frame: For the duration of the study (up to a maximum of 18.2 months). ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
- Patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
- Patients who completed Abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.
Exclusion Criteria:
The following patients will not be included in the study:
- Patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
- Hypersensitivity to adalimumab
- Pregnancy
- Lactation
- Age below 18
- Infectious diseases including tuberculosis
- Patients currently participating in another clinical trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163916
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| Study Director: | Andrey N Strugovschikov, MD | Abbott Russia |
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01163916 |
| Other Study ID Numbers: |
P10-272 |
| First Posted: | July 16, 2010 Key Record Dates |
| Results First Posted: | December 5, 2012 |
| Last Update Posted: | December 7, 2012 |
| Last Verified: | December 2012 |
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Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis |
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Spondylitis Arthritis Arthritis, Rheumatoid Arthritis, Psoriatic Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Bone Diseases, Infectious Infections Bone Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Psoriasis Skin Diseases, Papulosquamous Skin Diseases Ankylosis |