Rheumatoid ArthritisP @ WorkNCT02362074
Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by AbbVie at 32 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 401 participants
- Where
- 32 sitesCanada
- Study dates
- 21 Jan 2015to 6 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab
- Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS
- Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB
- Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol.
Who cannot join
- Subject cannot or will not sign a patient authorization
- Subject with a known hypersensitivity to Adalimumab, or any of its components
- 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
- Subjects currently participating in an investigational clinical trial
- Subjects treated with >1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited
- Subjects previously treated with targeted synthetic disease modifying agent.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Canada32 sites
Waterside Clinique /ID# 134190
Barrie, Ontario, L4M 6L2
Drs Nalin and Vandana Ahluwali /ID# 136485
Brampton, Ontario, L6T 0G1
Dr. Sanjay Dixit Medicine Professional Corporation /ID# 136486
Burlington, Ontario, L7L 0B7
Pont, Cranbrook, BC, CA /ID# 134511
Cranbrook, British Columbia, V1C 2R7
Dr. Chrisotomor Kouroukis & Dr /ID# 151189
Dundas, Ontario, L9H 1B7
Adachi Medicine Prof. Corp /ID# 152538
Hamilton, Ontario, L8N 1Y2
West Mountain Medical Center /ID# 134832
Hamilton, Ontario, L9C 5N2
Dr. Martin M.S. Lee Med Prof C /ID# 138333
Mississauga, Ontario, L5A 1W4
Brandusa Florica Med Prof Corp /ID# 134829
Mississauga, Ontario, L5A 3V8
Montgomery, Mississauga, CA /ID# 136943
Mississauga, Ontario, L5A 3V8
Credit Valley Rheumatology /ID# 134834
Mississauga, Ontario, L5M 2V8
Institut de Rhum. de Montreal /ID# 135289
Montreal, Quebec, H2L 1S6
Jewish General Hospital /ID# 204168
Montreal, Quebec, H3T 1E2
PSS Medical Inc. /ID# 134193
Montreal, Quebec, H3T 1Y3
Clinique de Rhumatologie de Montréal /ID# 162186
Montreal, Quebec, H4N 1C6
Rajwinder S. Dhillon Medicine /ID# 147756
Niagara Falls, Ontario, L2E 6A6
Capital North Therapeutics Res /ID# 134835
Ottawa, Ontario, K1Y 4G2
Setty, Owen Sound, CA /ID# 134189
Owen Sound, Ontario, N4K 1S4
Drs. M & W Teo Inc. /ID# 148641
Penticton, British Columbia, V2A 4Z1
The Medical Centre /ID# 134833
Peterborough, Ontario, K9J 7B3
Chuq - Chul /Id# 137054
Québec, G1V 4G2
Ctr. de Rheum de l'est du QC /ID# 135410
Rimouski, Quebec, G5L 8W1
Dr. Latha Naik /ID# 135813
Saskatoon, Saskatchewan, S7K 3H3
Nexus Clinical Research /ID# 135411
St. John's, Newfoundland and Labrador, A1B 5E8
St. Clare's Mercy Hospital /ID# 136737
St. John's, Newfoundland and Labrador, A1C 5B8
Dr. Juris Lazovskis Inc. /ID# 134510
Sydney, Nova Scotia, B1S 3N1
Involved Medicine /ID# 163880
Toronto, Ontario, M3H 5S4
Dr. Samuel K Silverberg /ID# 136496
Toronto, Ontario, M9V 4B8
The Arthritis Research Center /ID# 147466
Vancouver, British Columbia, V5Z 1L7
Kur, Vancouver, CA /ID# 135371
Vancouver, British Columbia, V5Z 3Y1
Rheum Disease Ctr of Montreal /ID# 135372
Westmount, Quebec, H3Z 2Z3
Manitoba Clinic /ID# 134830
Winnipeg, Manitoba, R3A 1M3
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab subjects | Subjects starting Adalimumab treatment at time of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Month 0 to Month 6
Change in Financial Loss
This is patient reported assessment of financial burden of RA.
Measured: From Month 0 to Month 6
Secondary outcomes (16)
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.
Measured: From Month 0 to Month 12, 18 and 24
Change in the Financial Loss
This is patient reported assessment of financial burden of RA.
Measured: From Month 0 to Month 12, 18 and 24
Change in patient pain
Pain is assessed using Visual Analogue Scale (VAS)
Measured: From Month 0 to Month 24
Change in Tender Joint Count (TJC)
This is assessed by the physician.
Measured: From Month 0 to Month 24
Change in Disease Activity Score (DAS) 28
Disease activity assessment is done by the physician.
Measured: From Month 0 to Month 24
Change in patient assessment of Global Disease Activity
It is assessed using VAS.
Measured: From Month 0 to Month 24
Change in Swollen Joint Count (SJC)
This is assessed by the physician.
Measured: From Month 0 to Month 24
Change in physician's assessment of Global Disease Activity
It is assessed using VAS.
Measured: From Month 0 to Month 24
Change in Health Assessment Questionnaire (HAQ)
This is patient reported functional assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Month 0 to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study start21 Jan 2015
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362074
- Sponsor's protocol ID
- P14-455
- Acronym
- P @ Work
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2015
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT02362074
- Acronym / sponsor ID
- P @ Work / P14-455
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab subjects | – | –Subjects starting Adalimumab treatment at time of enrollment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab
- Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS
- Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB
- Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol.
Key exclusion criteria (6 listed)
- Subject cannot or will not sign a patient authorization
- Subject with a known hypersensitivity to Adalimumab, or any of its components
- 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
- Subjects currently participating in an investigational clinical trial
- Subjects treated with >1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS)
Time frame: From Month 0 to Month 6
This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.
Change in Financial Loss
Time frame: From Month 0 to Month 6
This is patient reported assessment of financial burden of RA.
16 secondary outcomes
Change in Rheumatoid Arthritis-Work Instability (RA-WIS)
Time frame: From Month 0 to Month 12, 18 and 24
Change in the Financial Loss
Time frame: From Month 0 to Month 12, 18 and 24
Change in patient pain
Time frame: From Month 0 to Month 24
Change in Tender Joint Count (TJC)
Time frame: From Month 0 to Month 24
Change in Disease Activity Score (DAS) 28
Time frame: From Month 0 to Month 24
Change in patient assessment of Global Disease Activity
Time frame: From Month 0 to Month 24
Change in Swollen Joint Count (SJC)
Time frame: From Month 0 to Month 24
Change in physician's assessment of Global Disease Activity
Time frame: From Month 0 to Month 24
Change in Health Assessment Questionnaire (HAQ)
Time frame: From Month 0 to Month 24
Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR)
Time frame: From Month 0 to Month 24
Rate of Remission per Disease Activity Scale (DAS) 28
Time frame: From Month 0 to Month 24
Rate of Achieving Low Disease Activity (LDA) per Disease Activity Score (DAS) 28
Time frame: From Month 0 to Month 24
Rate of Remission Per Clinical Disease Activity Index (CDAI)
Time frame: From Month 0 to Month 24
Rate of Achieving Low Disease Activity (LDA) per CDAI
Time frame: From Month 0 to Month 24
Rate of Remission per Simplified Disease Activity Index (SDAI)
Time frame: From Month 0 to Month 24
Rate of Achieving Low Disease Activity (LDA) per SDAI
Time frame: From Month 0 to Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by AbbVie at 32 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS) (time frame: From Month 0 to Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.