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 currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01845818
First received: May 1, 2013
Last updated: July 22, 2014
Last verified: July 2014
  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 Impairmment- 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 Impairmment- 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 Impairmment- 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: December 2016
Estimated Primary Completion Date: December 2016 (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
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

Contacts
Contact: Simonne Lens, MD 0032 (0)10 477 811 Be.medicalinformation@abbvie.com
Contact: Maria Van den Enden, MD 0032 (0)10 477 811 Be.medicalinformation@abbvie.com

Locations
Belgium
Site Reference ID/Investigator# 99196 Recruiting
Aalst, Belgium, 9300
Principal Investigator: Site Reference ID/Investigator# 99196         
Site Reference ID/Investigator# 105396 Not yet recruiting
Amel, Belgium, 4770
Principal Investigator: Site Reference ID/Investigator# 105396         
Site Reference ID/Investigator# 118995 Not yet recruiting
Bonheiden, Belgium, 2820
Principal Investigator: Site Reference ID/Investigator# 118995         
Site Reference ID/Investigator# 119295 Withdrawn
Bonheiden, Belgium, 2820
Site Reference ID/Investigator# 99199 Not yet recruiting
Bruges, Belgium, 8000
Principal Investigator: Site Reference ID/Investigator# 99199         
Site Reference ID/Investigator# 99200 Withdrawn
Brussels, Belgium, 1180
Site Reference ID/Investigator# 99136 Not yet recruiting
Brussels, Belgium, 1190
Principal Investigator: Site Reference ID/Investigator# 99136         
Site Reference ID/Investigator# 99137 Not yet recruiting
Brussels, Belgium, 1050
Principal Investigator: Site Reference ID/Investigator# 99137         
Site Reference ID/Investigator# 105375 Not yet recruiting
Brussels, Belgium, 1040
Principal Investigator: Site Reference ID/Investigator# 105375         
Site Reference ID/Investigator# 105378 Not yet recruiting
Brussels, Belgium, 1070
Principal Investigator: Site Reference ID/Investigator# 105378         
Site Reference ID/Investigator# 118996 Not yet recruiting
Brussels, Belgium, 1081
Principal Investigator: Site Reference ID/Investigator# 118996         
Site Reference ID/Investigator# 99224 Not yet recruiting
Ceroux-Mousty, Belgium, 1341
Principal Investigator: Site Reference ID/Investigator# 99224         
Site Reference ID/Investigator# 116517 Withdrawn
Charleroi, Belgium, 6000
Site Reference ID/Investigator# 99221 Not yet recruiting
Ciney, Belgium, 5590
Principal Investigator: Site Reference ID/Investigator# 99221         
Site Reference ID/Investigator# 99135 Not yet recruiting
Edegem, Belgium, 2650
Principal Investigator: Site Reference ID/Investigator# 99135         
Site Reference ID/Investigator# 99217 Not yet recruiting
Erembodegem, Belgium, 9320
Principal Investigator: Site Reference ID/Investigator# 99217         
Site Reference ID/Investigator# 99219 Recruiting
Flemalle, Belgium, 4400
Principal Investigator: Site Reference ID/Investigator# 99219         
Site Reference ID/Investigator# 99218 Recruiting
Forchies-la-Marche, Belgium, 6141
Principal Investigator: Site Reference ID/Investigator# 99218         
Site Reference ID/Investigator# 99202 Recruiting
Genk, Belgium, 3600
Principal Investigator: Site Reference ID/Investigator# 99202         
Site Reference ID/Investigator# 99220 Not yet recruiting
Ghent, Belgium, B-9000
Principal Investigator: Site Reference ID/Investigator# 99220         
Site Reference ID/Investigator# 99195 Not yet recruiting
Gilly, Belgium, 6060
Principal Investigator: Site Reference ID/Investigator# 99195         
Site Reference ID/Investigator# 99201 Recruiting
Gistel, Belgium, 8470
Principal Investigator: Site Reference ID/Investigator# 99201         
Site Reference ID/Investigator# 105397 Not yet recruiting
Heist-op-den-Berg, Belgium, 2220
Principal Investigator: Site Reference ID/Investigator# 105397         
Site Reference ID/Investigator# 105379 Not yet recruiting
Heusy, Belgium, 4802
Principal Investigator: Site Reference ID/Investigator# 105379         
Site Reference ID/Investigator# 99223 Withdrawn
Jambes, Belgium, 5100
Site Reference ID/Investigator# 99138 Not yet recruiting
Liege, Belgium, 4000
Principal Investigator: Site Reference ID/Investigator# 99138         
Site Reference ID/Investigator# 99215 Not yet recruiting
Lokeren, Belgium, 9160
Principal Investigator: Site Reference ID/Investigator# 99215         
Site Reference ID/Investigator# 99222 Not yet recruiting
Mechelen, Belgium, 2800
Principal Investigator: Site Reference ID/Investigator# 99222         
Site Reference ID/Investigator# 99225 Not yet recruiting
Merelbeke, Belgium, 9820
Principal Investigator: Site Reference ID/Investigator# 99225         
Site Reference ID/Investigator# 105377 Not yet recruiting
Neder-Over-Heembeek, Belgium, 1200
Principal Investigator: Site Reference ID/Investigator# 105377         
Site Reference ID/Investigator# 124175 Not yet recruiting
Ostend, Belgium, 8400
Principal Investigator: Site Reference ID/Investigator# 124175         
Site Reference ID/Investigator# 99216 Not yet recruiting
Oudenaarde, Belgium, 9700
Principal Investigator: Site Reference ID/Investigator# 99216         
Site Reference ID/Investigator# 99139 Not yet recruiting
Roeselare, Belgium, 8800
Principal Investigator: Site Reference ID/Investigator# 99139         
Site Reference ID/Investigator# 99197 Not yet recruiting
Sijsele, Belgium, 8340
Principal Investigator: Site Reference ID/Investigator# 99197         
Site Reference ID/Investigator# 105376 Not yet recruiting
Sint-Niklaas, Belgium, 9100
Principal Investigator: Site Reference ID/Investigator# 105376         
Site Reference ID/Investigator# 105395 Not yet recruiting
St. Vith, Belgium, 4780
Principal Investigator: Site Reference ID/Investigator# 105395         
Site Reference ID/Investigator# 99198 Not yet recruiting
Turnhout, Belgium, 2300
Principal Investigator: Site Reference ID/Investigator# 99198         
Site Reference ID/Investigator# 105380 Not yet recruiting
Verviers, Belgium, 4800
Principal Investigator: Site Reference ID/Investigator# 105380         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Simonne Lens, MD AbbVie sa
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01845818     History of Changes
Other Study ID Numbers: P13-990
Study First Received: May 1, 2013
Last Updated: July 22, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by AbbVie:
work productivity
multicenter study

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

ClinicalTrials.gov processed this record on July 24, 2014