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

Abbott

Status: Completed

Conditions: Psoriatic Arthritis; Ankylosing Spondylitis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01163916

P10-272

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

252 participants in 1 patient group

Patients with RA, PsA and AS

Description:

Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) prescribed adalimumab as part of Routine Clinical Care in Russia.