N/A
Completed N=252
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
Source: ClinicalTrials.gov NCT01163916 ↗Enrolled (actual)
252
Serious AEs
0.8%
Results posted
Dec 2012
Primary outcomePrimary: Characteristics of Patients Prescribed Adalimumab: Education Level — 21; 2; 5; 34 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Characteristics of Patients Prescribed Adalimumab: Education Level |
21; 2; 5; 34; 9; 26 | — |
| PRIMARY Characteristics of Patients Prescribed Adalimumab: Occupation |
13; 5; 10; 10; 5; 12 | — |
| PRIMARY Characteristics of Patients Prescribed Adalimumab: Residence Status |
113; 33; 88; 13; 2; 3 | — |
| PRIMARY Characteristics of Patients Prescribed Adalimumab: Marital Status |
94; 24; 69; 32; 11; 21 | — |
| PRIMARY Characteristics of Patients Prescribed Adalimumab: Disease Severity |
0; 2; 0; 44; 14; 31 | — |
| PRIMARY Characteristics of Patients Prescribed Adalimumab: Duration of Disease |
71.70; 103.50; 50.90 | — |
| PRIMARY Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment |
96; 23; 20; 73; 16; 72 | — |
| SECONDARY Patient's Acceptability of Self-injections |
168; 10; 71; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Missed or Delayed Injections |
55.2; 57.1; 56.7; 21.6; 11.4; 21.1 | — |
| SECONDARY Duration of Treatment With Adalimumab |
52.10; 52.90; 52.30 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01163916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.