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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163916
• Other study ID #: P10-272
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: December 5, 2012
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: December 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Russian Federation	Site Ref # / Investigator 50728	Belgorod
Russian Federation	Site Ref # / Investigator 50737	Chelyabinsk
Russian Federation	Site Reference ID/Investigator# 6002	Ekaterinburg
Russian Federation	Site Ref # / Investigator 50731	Izhevsk
Russian Federation	Site Reference ID/Investigator# 29084	Kaliningrad
Russian Federation	Site Ref # / Investigator 50746	Khanty Mansisk
Russian Federation	Site Reference ID/Investigator# 29163	Khanty-Mansiysk
Russian Federation	Site Ref # / Investigator 50736	Krasnogorsk
Russian Federation	Site Ref # / Investigator 50727	Lipetsk
Russian Federation	Site Ref # / Investigator 50723	Moscow
Russian Federation	Site Ref # / Investigator 50724	Moscow
Russian Federation	Site Ref # / Investigator 50725	Moscow
Russian Federation	Site Ref # / Investigator 50732	Moscow
Russian Federation	Site Ref # / Investigator 50733	Moscow
Russian Federation	Site Ref # / Investigator 50738	Moscow
Russian Federation	Site Ref # / Investigator 50739	Moscow
Russian Federation	Site Ref # / Investigator 50740	Moscow
Russian Federation	Site Ref # / Investigator 50741	Moscow
Russian Federation	Site Ref # / Investigator 50742	Moscow
Russian Federation	Site Ref # / Investigator 50743	Moscow
Russian Federation	Site Ref # / Investigator 50744	Moscow
Russian Federation	Site Ref # / Investigator 50745	Moscow
Russian Federation	Site Reference ID/Investigator# 28989	Moscow
Russian Federation	Site Reference ID/Investigator# 28990	Moscow
Russian Federation	Site Reference ID/Investigator# 29195	Moscow
Russian Federation	Site Reference ID/Investigator# 29482	Moscow
Russian Federation	Site Reference ID/Investigator# 29483	Moscow
Russian Federation	Site Reference ID/Investigator# 28956	Nizhnevartovsk
Russian Federation	Site Reference ID/Investigator# 28968	Perm
Russian Federation	Site Reference ID/Investigator# 28969	Perm
Russian Federation	Site Reference ID/Investigator# 32403	Saint Petersburg
Russian Federation	Site Ref # / Investigator 50729	Salekhard
Russian Federation	Site Reference ID/Investigator# 28957	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 28997	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 28999	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 29001	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 29008	Surgut
Russian Federation	Site Reference ID/Investigator# 32404	Tula
Russian Federation	Site Reference ID/Investigator# 29095	Ulyanovsk
Russian Federation	Site Ref # / Investigator 50734	V. Novgorod
Russian Federation	Site Ref # / Investigator 50730	Vologda
Russian Federation	Site Ref # / Investigator 50726	Voronezh
Russian Federation	Site Ref # / Investigator 50735	Voronezh

Sponsors (3)

Lead Sponsor	Collaborator
Abbott	Almedis, Scientific Research Institute of Rheumatology, Moscow

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline	No
Primary	Characteristics of Patients Prescribed Adalimumab: Occupation	Participants were asked to indicate their occupation at the Baseline visit.	Baseline	No
Primary	Characteristics of Patients Prescribed Adalimumab: Residence Status	Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.	Baseline	No
Primary	Characteristics of Patients Prescribed Adalimumab: Marital Status	Participants were asked to indicate their marital status at the Baseline visit.	Baseline	No
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.	Baseline	No
Primary	Characteristics of Patients Prescribed Adalimumab: Duration of Disease	Duration of disease was defined as the time from diagnosis until study entry.	Baseline	No
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.	Baseline and at each follow-up visit (up to a maximum of 18.2 months).	No
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.	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.	No
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.	For the duration of the study (up to a maximum of 18.2 months).	No
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.	For the duration of the study (up to a maximum of 18.2 months).	No