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

NCT01163916 | Completed Results

• 1 other identifier: P10-272
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 43

Brief 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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

Keywords

Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (7)

• 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

  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).

Secondary Outcomes (3)

• Patient's Acceptability of Self-injections

  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

  For the duration of the study (up to a maximum of 18.2 months).

• Duration of Treatment With Adalimumab

  For the duration of the study (up to a maximum of 18.2 months).

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead
• Scientific Research Institute of Rheumatology, Moscow: collaborator
• Almedis: collaborator

Study Sites (43)

Site Ref # / Investigator 50728

Belgorod, 308007, Russia

Location

Site Ref # / Investigator 50737

Chelyabinsk, 454047, Russia

Location

Site Ref # / Investigator 50731

Izhevsk, 426009, Russia

Location

Site Reference ID/Investigator# 29084

Kaliningrad, 236000, Russia

Location

Site Reference ID/Investigator# 29163

Khanty-Mansiysk, 626200, Russia

Location

Site Ref # / Investigator 50746

Khanty-Mansiysk, 628600, Russia

Location

Site Ref # / Investigator 50736

Krasnogorsk, 143420, Russia

Location

Site Ref # / Investigator 50727

Lipetsk, 308036, Russia

Location

Site Ref # / Investigator 50723

Moscow, 105203, Russia

Location

Site Ref # / Investigator 50725

Moscow, 105229, Russia

Location

Site Ref # / Investigator 50742

Moscow, 109451, Russia

Location

Site Ref # / Investigator 50743

Moscow, 109451, Russia

Location

Site Ref # / Investigator 50724

Moscow, 115682, Russia

Location

Site Ref # / Investigator 50739

Moscow, 121356, Russia

Location

Site Ref # / Investigator 50732

Moscow, 123060, Russia

Location

Site Ref # / Investigator 50738

Moscow, 123098, Russia

Location

Site Ref # / Investigator 50744

Moscow, 123308, Russia

Location

Site Reference ID/Investigator# 28989

Moscow, 125009, Russia

Location

Site Reference ID/Investigator# 28990

Moscow, 125009, Russia

Location

Site Reference ID/Investigator# 29195

Moscow, 125009, Russia

Location

Site Reference ID/Investigator# 29482

Moscow, 125009, Russia

Location

Site Reference ID/Investigator# 29483

Moscow, 125009, Russia

Location

Site Ref # / Investigator 50740

Moscow, 127206, Russia

Location

Site Ref # / Investigator 50733

Moscow, 127473, Russia

Location

Site Ref # / Investigator 50745

Moscow, 127543, Russia

Location

Site Ref # / Investigator 50741

Moscow, 127642, Russia

Location

Site Reference ID/Investigator# 28956

Nizhnevartovsk, 628600, Russia

Location

Site Reference ID/Investigator# 28968

Perm, 614014, Russia

Location

Site Reference ID/Investigator# 28969

Perm, 614014, Russia

Location

Site Reference ID/Investigator# 28957

Saint Petersburg, 190000, Russia

Location

Site Reference ID/Investigator# 28997

Saint Petersburg, 190000, Russia

Location

Site Reference ID/Investigator# 28999

Saint Petersburg, 190000, Russia

Location

Site Reference ID/Investigator# 29001

Saint Petersburg, 190000, Russia

Location

Site Reference ID/Investigator# 32403

Saint Petersburg, 191015, Russia

Location

Site Ref # / Investigator 50729

Salekhard, 629001, Russia

Location

Site Reference ID/Investigator# 29008

Surgut, 628400, Russia

Location

Site Reference ID/Investigator# 32404

Tula, 300036, Russia

Location

Site Reference ID/Investigator# 29095

Ulyanovsk, 432000, Russia

Location

Site Ref # / Investigator 50734

V. Novgorod, 173008, Russia

Location

Site Ref # / Investigator 50730

Vologda, 160001, Russia

Location

Site Ref # / Investigator 50735

Voronezh, 394024, Russia

Location

Site Ref # / Investigator 50726

Voronezh, 394082, Russia

Location

Site Reference ID/Investigator# 6002

Yekaterinburg, 620000, Russia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Andrey N Strugovschikov, MD

  Abbott Russia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: July 16, 2010
• Study Start: January 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 7, 2012
• Results First Posted: December 5, 2012

Record last verified: 2012-12

Locations

RU (43)