Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium

NCT01845818 | Completed Results

• 1 other identifier: P13-990
• Study Type: observational
• Target: 183
• Locations: 0 countries
• Sites: N/A

Brief Summary

This observational study will document to what extent in daily clinical practice the work productivity is affected before and after the start of adalimumab treatment. Changes in the employment status and work productivity of participants with AS and PsA before and after the start of adalimumab will be noted. The relationship between employment status, work productivity, disease activity and clinical evaluations will be evaluated. Since AS and PsA might be diseases with a strong impact on the daily life of the participant, an evaluation will be performed to the effect of the disease on quality of life and work productivity.

Conditions

Ankylosing Spondylitis; Psoriatic Arthritis

Keywords

work productivity; multicenter study

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)

  The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.

  Baseline, Month 18

Secondary Outcomes (16)

• Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately)

  Baseline, Month 18

• Number of Participants Employed at Each Assessed Visit

  Baseline, Months 3, 6, 12, 18

• Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit

  Baseline, Months 3, 6, 12, 18

• Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit

  Baseline, Months 3, 6, 12, 18

• Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit

  Baseline, Months 3, 6, 12, 18

Study Arms (1)

Ankylosing Spondylitis and Psoriatic Arthritis

Participants with AS and PsA and in whom adalimumab treatment is initiated. All medication will be prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants with AS and PsA followed in university or peripheral hospitals or peripheral private practices with experience in AS and PsA care.

You may qualify if:

• Patient \>= 18 years and \<= 50 years
• Patient diagnosed with AS or PsA
• Patient to be initiated on adalimumab (according to the Marketing Authorization and Belgian reimbursement criteria)
• Patient willing to sign informed consent

You may not qualify if:

• Any contraindication for adalimumab as specified in the corresponding Summary of Product Characteristics (SmPC)
• Patient previously treated with biologics
• Patient participating in other AbbVie-sponsored trials

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Spondylitis, Ankylosing; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: June 5, 2013
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: January 9, 2019
• Results First Posted: January 9, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share