Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice

NCT01754727 | Completed Results

• 1 other identifier: P13-682
• Study Type: observational
• Target: 452
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; Effectiveness; Post-marketing observational study (PMOS); Adalimumab; Humira®

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12

  The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.

  Month 0 (baseline) and Month 12

Secondary Outcomes (10)

• Percentage of Participants Achieving BASDAI 50

  Month 3, Month 6 and Month 9

• Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline

  Month 3, Month 6, Month 9 and Month 12

• Mean Change in the Number of Hospital Inpatient Days

  12 months prior to month 0 (baseline) and 12 months prior to month 12

• Mean Change in the Number of Hospitalizations

  12 months prior to month 0 (baseline) and 12 months prior to month 12

• Mean Change in the Number of Sick Leave Days

  12 months prior to month 0 (baseline) and 12 months prior to month 12

Study Arms (1)

Participants with Ankylosing Spondylitis (AS)

Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.

Eligibility Criteria

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

Study Population

Study population consisted of participants with ankylosing spondylitis (AS) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.

You may qualify if:

• Had ankylosing spondylitis (AS) and was eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines,
• Had been started on adalimumab therapy no more than one (1) month prior to the study enrollment
• Had negative result of tuberculosis (TB) screening test or was receiving tuberculosis prophylaxis as per local guidelines
• Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

You may not qualify if:

• \- Had contraindications for the treatment with adalimumab

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Liliana Iosub

  AbbVie

  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: December 19, 2012
• First Posted: December 21, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01