Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis (P @ Work)

Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis.

The purpose of this study is to describe the impact of treatment with adalimumab on work related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated in Canada.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 401

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Chuq - Chul /Id# 137054
  • British Columbia
    • Cranbrook, British Columbia, Canada, V1C 2R7
      • Pont, Cranbrook, BC, CA /ID# 134511
    • Penticton, British Columbia, Canada, V2A 4Z1
      • Drs. M & W Teo Inc. /ID# 148641
    • Vancouver, British Columbia, Canada, V5Z 1L7
      • The Arthritis Research Center /ID# 147466
    • Vancouver, British Columbia, Canada, V5Z 3Y1
      • Kur, Vancouver, CA /ID# 135371
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Manitoba Clinic /ID# 134830
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 5E8
      • Nexus Clinical Research /ID# 135411
    • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
      • St. Clare's Mercy Hospital /ID# 136737
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1S 3N1
      • Dr. Juris Lazovskis Inc. /ID# 134510
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Waterside Clinique /ID# 134190
    • Brampton, Ontario, Canada, L6T 0G1
      • Drs Nalin and Vandana Ahluwali /ID# 136485
    • Burlington, Ontario, Canada, L7L 0B7
      • Dr. Sanjay Dixit Medicine Professional Corporation /ID# 136486
    • Dundas, Ontario, Canada, L9H 1B7
      • Dr. Chrisotomor Kouroukis & Dr /ID# 151189
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Adachi Medicine Prof. Corp /ID# 152538
    • Hamilton, Ontario, Canada, L9C 5N2
      • West Mountain Medical Center /ID# 134832
    • Mississauga, Ontario, Canada, L5A 1W4
      • Dr. Martin M.S. Lee Med Prof C /ID# 138333
    • Mississauga, Ontario, Canada, L5A 3V8
      • Brandusa Florica Med Prof Corp /ID# 134829
    • Mississauga, Ontario, Canada, L5A 3V8
      • Montgomery, Mississauga, CA /ID# 136943
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley Rheumatology /ID# 134834
    • Niagara Falls, Ontario, Canada, L2E 6A6
      • Rajwinder S. Dhillon Medicine /ID# 147756
    • Ottawa, Ontario, Canada, K1Y 4G2
      • Capital North Therapeutics Res /ID# 134835
    • Owen Sound, Ontario, Canada, N4K 1S4
      • Setty, Owen Sound, CA /ID# 134189
    • Peterborough, Ontario, Canada, K9J 7B3
      • The Medical Centre /ID# 134833
    • Toronto, Ontario, Canada, M3H 5S4
      • Involved Medicine /ID# 163880
    • Toronto, Ontario, Canada, M9V 4B8
      • Dr. Samuel K Silverberg /ID# 136496
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
      • Institut de Rhum. de Montreal /ID# 135289
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital /ID# 204168
    • Montreal, Quebec, Canada, H3T 1Y3
      • PSS Medical Inc. /ID# 134193
    • Montréal, Quebec, Canada, H4N 1C6
      • Clinique de Rhumatologie de Montréal /ID# 162186
    • Rimouski, Quebec, Canada, G5L 8W1
      • Ctr. de Rheum de l'est du QC /ID# 135410
    • Westmount, Quebec, Canada, H3Z 2Z3
      • Rheum Disease Ctr of Montreal /ID# 135372
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 3H3
      • Dr. Latha Naik /ID# 135813

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This is a Multi-Center Canadian Observational Study that will enroll rheumatoid arthristis (RA) subjects for whom the treating physician has decided to treat with adalimumab.

Description

Inclusion Criteria:

1. Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab
2. Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS
3. Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB
4. Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol.

Exclusion Criteria:

1. Subject cannot or will not sign a patient authorization
2. Subject with a known hypersensitivity to Adalimumab, or any of its components
3. Presence of any condition that, in the opinion of the treating physician, prohibits the subject from participating in the study or obscures the assessment of the treatment of RA
4. Subjects currently participating in an investigational clinical trial
5. Subjects treated with >1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited
6. Subjects previously treated with targeted synthetic disease modifying agent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adalimumab subjects; Subjects starting Adalimumab treatment at time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS)	This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.	From Month 0 to Month 6
Change in Financial Loss	This is patient reported assessment of financial burden of RA.	From Month 0 to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rheumatoid Arthritis-Work Instability (RA-WIS)	This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.	From Month 0 to Month 12, 18 and 24
Change in the Financial Loss	This is patient reported assessment of financial burden of RA.	From Month 0 to Month 12, 18 and 24
Change in patient pain	Pain is assessed using Visual Analogue Scale (VAS)	From Month 0 to Month 24
Change in Tender Joint Count (TJC)	This is assessed by the physician.	From Month 0 to Month 24
Change in Disease Activity Score (DAS) 28	Disease activity assessment is done by the physician.	From Month 0 to Month 24
Change in patient assessment of Global Disease Activity	It is assessed using VAS.	From Month 0 to Month 24
Change in Swollen Joint Count (SJC)	This is assessed by the physician.	From Month 0 to Month 24
Change in physician's assessment of Global Disease Activity	It is assessed using VAS.	From Month 0 to Month 24
Change in Health Assessment Questionnaire (HAQ)	This is patient reported functional assessment.	From Month 0 to Month 24
Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR)	CRP/ESR values are measured as an inflammatory parameter. Low CRP and ESR values mean less inflammation.	From Month 0 to Month 24
Rate of Remission per Disease Activity Scale (DAS) 28	The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score less than 2.6 indicates clinical remission.	From Month 0 to Month 24
Rate of Achieving Low Disease Activity (LDA) per Disease Activity Score (DAS) 28	The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores range from 0 to 10 with LDA defined as a score from 2.6 to < 3.2.	From Month 0 to Month 24
Rate of Remission Per Clinical Disease Activity Index (CDAI)	The CDAI is used to evaluate disease activity in patients with Rheumatoid Arthritis.	From Month 0 to Month 24
Rate of Achieving Low Disease Activity (LDA) per CDAI	The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10.	From Month 0 to Month 24
Rate of Remission per Simplified Disease Activity Index (SDAI)	The SDAI is a validated measure of rheumatoid arthritis disease activity. Scores on the SDAI range from 0 to 86 with a SDAI score ≤3.3 indicating clinical remission.	From Month 0 to Month 24
Rate of Achieving Low Disease Activity (LDA) per SDAI	The SDAI is a validated measure of rheumatoid arthritis disease activity. Scores on the SDAI range from 0 to 86 with a SDAI score <11 indicating LDA.	From Month 0 to Month 24

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2015
• Primary Completion (Actual): March 6, 2020
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: P14-455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No