Clinical trial NCT02362074: Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis
Official title: Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-02-12
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS)
timeFrame: From Month 0 to Month 6
measure: Change in Financial Loss
timeFrame: From Month 0 to Month 6
Secondary outcomes:
measure: Change in Rheumatoid Arthritis-Work Instability (RA-WIS)
timeFrame: From Month 0 to Month 12, 18 and 24
measure: Change in the Financial Loss
timeFrame: From Month 0 to Month 12, 18 and 24
measure: Change in patient pain
timeFrame: From Month 0 to Month 24
measure: Change in Tender Joint Count (TJC)
timeFrame: From Month 0 to Month 24
measure: Change in Disease Activity Score (DAS) 28
timeFrame: From Month 0 to Month 24
measure: Change in patient assessment of Global Disease Activity
timeFrame: From Month 0 to Month 24
measure: Change in Swollen Joint Count (SJC)
timeFrame: From Month 0 to Month 24
measure: Change in physician's assessment of Global Disease Activity
timeFrame: From Month 0 to Month 24
measure: Change in Health Assessment Questionnaire (HAQ)
timeFrame: From Month 0 to Month 24
measure: Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR)
timeFrame: From Month 0 to Month 24
measure: Rate of Remission per Disease Activity Scale (DAS) 28
timeFrame: From Month 0 to Month 24
measure: Rate of Achieving Low Disease Activity (LDA) per Disease Activity Score (DAS) 28
timeFrame: From Month 0 to Month 24
measure: Rate of Remission Per Clinical Disease Activity Index (CDAI)
timeFrame: From Month 0 to Month 24
measure: Rate of Achieving Low Disease Activity (LDA) per CDAI
timeFrame: From Month 0 to Month 24
measure: Rate of Remission per Simplified Disease Activity Index (SDAI)
timeFrame: From Month 0 to Month 24
measure: Rate of Achieving Low Disease Activity (LDA) per SDAI
timeFrame: From Month 0 to Month 24
Other outcomes:
Locations:
city: Cranbrook
country: Canada
facility: Pont, Cranbrook, BC, CA /ID# 134511
state: British Columbia
city: Penticton
country: Canada
facility: Drs. M & W Teo Inc. /ID# 148641
state: British Columbia
city: Vancouver
country: Canada
facility: The Arthritis Research Center /ID# 147466
state: British Columbia
city: Vancouver
country: Canada
facility: Kur, Vancouver, CA /ID# 135371
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 134830
state: Manitoba
city: St. John's
country: Canada
facility: Nexus Clinical Research /ID# 135411
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: St. Clare's Mercy Hospital /ID# 136737
state: Newfoundland and Labrador
city: Sydney
country: Canada
facility: Dr. Juris Lazovskis Inc. /ID# 134510
state: Nova Scotia
city: Barrie
country: Canada
facility: Waterside Clinique /ID# 134190
state: Ontario
city: Brampton
country: Canada
facility: Drs Nalin and Vandana Ahluwali /ID# 136485
state: Ontario
city: Burlington
country: Canada
facility: Dr. Sanjay Dixit Medicine Professional Corporation /ID# 136486
state: Ontario
city: Dundas
country: Canada
facility: Dr. Chrisotomor Kouroukis & Dr /ID# 151189
state: Ontario
city: Hamilton
country: Canada
facility: Adachi Medicine Prof. Corp /ID# 152538
state: Ontario
city: Hamilton
country: Canada
facility: West Mountain Medical Center /ID# 134832
state: Ontario
city: Mississauga
country: Canada
facility: Dr. Martin M.S. Lee Med Prof C /ID# 138333
state: Ontario
city: Mississauga
country: Canada
facility: Brandusa Florica Med Prof Corp /ID# 134829
state: Ontario
city: Mississauga
country: Canada
facility: Montgomery, Mississauga, CA /ID# 136943
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology /ID# 134834
state: Ontario
city: Niagara Falls
country: Canada
facility: Rajwinder S. Dhillon Medicine /ID# 147756
state: Ontario
city: Ottawa
country: Canada
facility: Capital North Therapeutics Res /ID# 134835
state: Ontario
city: Owen Sound
country: Canada
facility: Setty, Owen Sound, CA /ID# 134189
state: Ontario
city: Peterborough
country: Canada
facility: The Medical Centre /ID# 134833
state: Ontario
city: Toronto
country: Canada
facility: Involved Medicine /ID# 163880
state: Ontario
city: Toronto
country: Canada
facility: Dr. Samuel K Silverberg /ID# 136496
state: Ontario
city: Montreal
country: Canada
facility: Institut de Rhum. de Montreal /ID# 135289
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital /ID# 204168
state: Quebec
city: Montreal
country: Canada
facility: PSS Medical Inc. /ID# 134193
state: Quebec
city: Montréal
country: Canada
facility: Clinique de Rhumatologie de Montréal /ID# 162186
state: Quebec
city: Rimouski
country: Canada
facility: Ctr. de Rheum de l'est du QC /ID# 135410
state: Quebec
city: Westmount
country: Canada
facility: Rheum Disease Ctr of Montreal /ID# 135372
state: Quebec
city: Saskatoon
country: Canada
facility: Dr. Latha Naik /ID# 135813
state: Saskatchewan
city: Quebec
country: Canada
facility: Chuq - Chul /Id# 137054
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: