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 (SPACTIVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01845818
First received: May 1, 2013
Last updated: August 9, 2016
Last verified: August 2016
  Purpose

This observational study will document to what extend 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 patients 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 very invalidating diseases with a strong impact on the daily life of the patient, an evaluation will be performed to the effect of the disease on Quality of Life and work productivity.


Condition
Ankylosing Spondylitis
Psoriatic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study in AS and PsA Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in total work productivity impairment due to ankylosing spondylitis and psoriatic arthritis [ Time Frame: From Day 0 to 18 months ] [ Designated as safety issue: No ]
    18 months versus baseline in all patients, measured by the Work Productivity and Activity Impairment-Specific Health Problem questionnaire. (Patient reported outcome)


Secondary Outcome Measures:
  • Change in evolution of employment status and work productivity after initiation of adalimumab treatment between ankylosing spondylitis and psoriatic arthritis patients throughout the study, measured by Work Productivity and Activity Impairment [ Time Frame: From Day 0 to 18 months ] [ Designated as safety issue: No ]
  • Evolution over time of work productivity: (observed for ankylosing spondylitis and psoriatic arthritis combined and separately): Number of patients that are employed at each assessed visit [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Health Related Quality of Life - Health Assessment Questionnaire - Disability Index - Patient reported outcome (psoriatic arthritis) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Disease activity measures and clinical evaluations - Body Surface Area - psoriatic arthritis [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Health Related Quality of Life - Dermatology Life Quality Index - Patient reported outcome (psoriatic arthritis) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Health Related Quality of Life - Health Assessment Questionnaire modified for spondyloarthropathies - Patient reported outcome (ankylosing spondylitis) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Disease activity measures and clinical evaluations - Disease Activity Score 28 - Psoriatic arthritis [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Disease activity measures and clinical evaluations - Bath Ankylosing Spondylitis Disease Activity Index - ankylosing spondylitis [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Disease activity measures and clinical evaluations - Acute phase reactants (C-Reactive Protein / Erythrocyte Sedimentation Rate) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Disease activity measures and clinical evaluations - Visual Analogue Scale [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Evolution over time of work productivity:(observed for ankylosing spondylitis and psoriatic arthritis combined and separately): Percentage of missed working hours (absenteeism) due to ankylosing spondylitis/psoriatic arthritis 7 days prior to each visit [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
    The Work Productivity and Activity Impairment- Specific Health Problem, a validated questionnaire for the self-assessment of work productivity and activity impairment with reference to a specific health problem, is used. All dimensions relate to the past seven days. Scores are transformed into percentages. Higher scores indicate greater impairment.

  • Evolution over time of work productivity:(observed combined and separately):Assessment of the effect of ankylosing spondylitis or psoriatic arthritis on the ability to do regular daily activities during the 7 days prior to each visit(activity impairment) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
    The Work Productivity and Activity Impairment- Specific Health Problem, a validated questionnaire for the self-assessment of work productivity and activity impairment with reference to a specific health problem, is used. All dimensions relate to the past seven days. Scores are transformed into percentages. Higher scores indicate greater impairment.

  • Evolution over time of work productivity: (observed combined and separately): Assessment of the effect of ankylosing spondylitis or psoriatic arthritis on productivity while working during the 7 days prior to each visit (presenteeism) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
    The Work Productivity and Activity Impairment- Specific Health Problem, a validated questionnaire for the self-assessment of work productivity and activity impairment with reference to a specific health problem, is used. All dimensions relate to the past seven days. Scores are transformed into percentages. Higher scores indicate greater impairment.


Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Ankylosing Spondylitis and Psoriatic Arthritis
Patients with Ankylosing Spondylitis and Psoriatic Arthritis 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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Ankylosing Spondylitis and Psoriatic Arthritis followed in university or peripheral hospitals or peripheral private practices with experience in Ankylosing Spondylitis and Psoriatic Arthritis care.
Criteria

Inclusion Criteria:

  • Patient >= 18 years and <= 50 years
  • Patient diagnosed with Ankylosing Spondylitis or Psoriatic Arthritis
  • Patient to be initiated on Adalimumab (according to the Marketing Authorization and Belgian reimbursement criteria)
  • Patient willing to sign Informed Consent

Exclusion Criteria:

  • Any contraindication for Adalimumab as specified in the corresponding SmPC
  • Patient previously treated with biologics
  • Patient participating in other AbbVie-sponsored trials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845818

Locations
Belgium
Site Reference ID/Investigator# 99196
Aalst, Belgium, 9300
Site Reference ID/Investigator# 105396
Amel, Belgium, 4770
Site Reference ID/Investigator# 118995
Bonheiden, Belgium, 2820
Site Reference ID/Investigator# 99199
Bruges, Belgium, 8000
Site Reference ID/Investigator# 105375
Brussels, Belgium, 1040
Site Reference ID/Investigator# 105378
Brussels, Belgium, 1070
Site Reference ID/Investigator# 99136
Brussels, Belgium, 1190
Site Reference ID/Investigator# 99224
Ceroux-Mousty, Belgium, 1341
Site Reference ID/Investigator# 99221
Ciney, Belgium, 5590
Site Reference ID/Investigator# 99135
Edegem, Belgium, 2650
Site Reference ID/Investigator# 99219
Flemalle, Belgium, 4400
Site Reference ID/Investigator# 99218
Forchies-la-Marche, Belgium, 6141
Site Reference ID/Investigator# 99202
Genk, Belgium, 3600
Site Reference ID/Investigator# 99195
Gilly, Belgium, 6060
Site Reference ID/Investigator# 99201
Gistel, Belgium, 8470
Site Reference ID/Investigator# 105397
Heist-op-den-Berg, Belgium, 2220
Site Reference ID/Investigator# 105379
Heusy, Belgium, 4802
Site Reference ID/Investigator# 99138
Liege, Belgium, 4000
Site Reference ID/Investigator# 99215
Lokeren, Belgium, 9160
Site Reference ID/Investigator# 99222
Mechelen, Belgium, 2800
Site Reference ID/Investigator# 99225
Merelbeke, Belgium, 9820
Site Reference ID/Investigator# 105377
Neder-Over-Heembeek, Belgium, 1200
Site Reference ID/Investigator# 99216
Oudenaarde, Belgium, 9700
Site Reference ID/Investigator# 99139
Roeselare, Belgium, 8800
Site Reference ID/Investigator# 99197
Sijsele, Belgium, 8340
Site Reference ID/Investigator# 105376
Sint-Niklaas, Belgium, 9100
Site Reference ID/Investigator# 99198
Turnhout, Belgium, 2300
Site Reference ID/Investigator# 105380
Verviers, Belgium, 4800
Site Reference ID/Investigator# 131516
Yvoir, Belgium, 5530
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Simonne Lens, MD AbbVie sa
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01845818     History of Changes
Other Study ID Numbers: P13-990 
Study First Received: May 1, 2013
Last Updated: August 9, 2016
Health Authority: Belgium: Ethics Committee

Keywords provided by AbbVie:
work productivity
multicenter study

Additional relevant MeSH terms:
Arthritis
Spondylitis
Spondylitis, Ankylosing
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 25, 2016