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

Rheumatoid Arthritis Clinical Trial

— P @ Work  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362074
• Other study ID #: P14-455
• Status: Completed
• Start date: January 21, 2015
• Est. completion date: March 6, 2020

Study information

• Verified date: February 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Canada	Waterside Clinique /ID# 134190	Barrie	Ontario
Canada	Drs Nalin and Vandana Ahluwali /ID# 136485	Brampton	Ontario
Canada	Dr. Sanjay Dixit Medicine Professional Corporation /ID# 136486	Burlington	Ontario
Canada	Pont, Cranbrook, BC, CA /ID# 134511	Cranbrook	British Columbia
Canada	Dr. Chrisotomor Kouroukis & Dr /ID# 151189	Dundas	Ontario
Canada	Adachi Medicine Prof. Corp /ID# 152538	Hamilton	Ontario
Canada	West Mountain Medical Center /ID# 134832	Hamilton	Ontario
Canada	Brandusa Florica Med Prof Corp /ID# 134829	Mississauga	Ontario
Canada	Credit Valley Rheumatology /ID# 134834	Mississauga	Ontario
Canada	Dr. Martin M.S. Lee Med Prof C /ID# 138333	Mississauga	Ontario
Canada	Montgomery, Mississauga, CA /ID# 136943	Mississauga	Ontario
Canada	Institut de Rhum. de Montreal /ID# 135289	Montreal	Quebec
Canada	Jewish General Hospital /ID# 204168	Montreal	Quebec
Canada	PSS Medical Inc. /ID# 134193	Montreal	Quebec
Canada	Clinique de Rhumatologie de Montréal /ID# 162186	Montréal	Quebec
Canada	Rajwinder S. Dhillon Medicine /ID# 147756	Niagara Falls	Ontario
Canada	Capital North Therapeutics Res /ID# 134835	Ottawa	Ontario
Canada	Setty, Owen Sound, CA /ID# 134189	Owen Sound	Ontario
Canada	Drs. M & W Teo Inc. /ID# 148641	Penticton	British Columbia
Canada	The Medical Centre /ID# 134833	Peterborough	Ontario
Canada	Chuq - Chul /Id# 137054	Quebec
Canada	Ctr. de Rheum de l'est du QC /ID# 135410	Rimouski	Quebec
Canada	Dr. Latha Naik /ID# 135813	Saskatoon	Saskatchewan
Canada	Nexus Clinical Research /ID# 135411	St. John's	Newfoundland and Labrador
Canada	St. Clare's Mercy Hospital /ID# 136737	St. John's	Newfoundland and Labrador
Canada	Dr. Juris Lazovskis Inc. /ID# 134510	Sydney	Nova Scotia
Canada	Dr. Samuel K Silverberg /ID# 136496	Toronto	Ontario
Canada	Involved Medicine /ID# 163880	Toronto	Ontario
Canada	Kur, Vancouver, CA /ID# 135371	Vancouver	British Columbia
Canada	The Arthritis Research Center /ID# 147466	Vancouver	British Columbia
Canada	Rheum Disease Ctr of Montreal /ID# 135372	Westmount	Quebec
Canada	Manitoba Clinic /ID# 134830	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Financial Loss	This is patient reported assessment of financial burden of RA.	From Month 0 to Month 6
Secondary	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
Secondary	Change in the Financial Loss	This is patient reported assessment of financial burden of RA.	From Month 0 to Month 12, 18 and 24
Secondary	Change in patient pain	Pain is assessed using Visual Analogue Scale (VAS)	From Month 0 to Month 24
Secondary	Change in Tender Joint Count (TJC)	This is assessed by the physician.	From Month 0 to Month 24
Secondary	Change in Disease Activity Score (DAS) 28	Disease activity assessment is done by the physician.	From Month 0 to Month 24
Secondary	Change in patient assessment of Global Disease Activity	It is assessed using VAS.	From Month 0 to Month 24
Secondary	Change in Swollen Joint Count (SJC)	This is assessed by the physician.	From Month 0 to Month 24
Secondary	Change in physician's assessment of Global Disease Activity	It is assessed using VAS.	From Month 0 to Month 24
Secondary	Change in Health Assessment Questionnaire (HAQ)	This is patient reported functional assessment.	From Month 0 to Month 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis