- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02362074
Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis (P @ Work)
9. februar 2021 opdateret af: AbbVie
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
401
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Quebec, Canada, G1V 4G2
- Chuq - Chul /Id# 137054
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British Columbia
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Cranbrook, British Columbia, Canada, V1C 2R7
- Pont, Cranbrook, BC, CA /ID# 134511
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Penticton, British Columbia, Canada, V2A 4Z1
- Drs. M & W Teo Inc. /ID# 148641
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Vancouver, British Columbia, Canada, V5Z 1L7
- The Arthritis Research Center /ID# 147466
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Vancouver, British Columbia, Canada, V5Z 3Y1
- Kur, Vancouver, CA /ID# 135371
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M3
- Manitoba Clinic /ID# 134830
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 5E8
- Nexus Clinical Research /ID# 135411
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St. John's, Newfoundland and Labrador, Canada, A1C 5B8
- St. Clare's Mercy Hospital /ID# 136737
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Nova Scotia
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Sydney, Nova Scotia, Canada, B1S 3N1
- Dr. Juris Lazovskis Inc. /ID# 134510
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Ontario
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Barrie, Ontario, Canada, L4M 6L2
- Waterside Clinique /ID# 134190
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Brampton, Ontario, Canada, L6T 0G1
- Drs Nalin and Vandana Ahluwali /ID# 136485
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Burlington, Ontario, Canada, L7L 0B7
- Dr. Sanjay Dixit Medicine Professional Corporation /ID# 136486
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Dundas, Ontario, Canada, L9H 1B7
- Dr. Chrisotomor Kouroukis & Dr /ID# 151189
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Hamilton, Ontario, Canada, L8N 1Y2
- Adachi Medicine Prof. Corp /ID# 152538
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Hamilton, Ontario, Canada, L9C 5N2
- West Mountain Medical Center /ID# 134832
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Mississauga, Ontario, Canada, L5A 1W4
- Dr. Martin M.S. Lee Med Prof C /ID# 138333
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Mississauga, Ontario, Canada, L5A 3V8
- Brandusa Florica Med Prof Corp /ID# 134829
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Mississauga, Ontario, Canada, L5A 3V8
- Montgomery, Mississauga, CA /ID# 136943
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Mississauga, Ontario, Canada, L5M 2V8
- Credit Valley Rheumatology /ID# 134834
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Niagara Falls, Ontario, Canada, L2E 6A6
- Rajwinder S. Dhillon Medicine /ID# 147756
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Ottawa, Ontario, Canada, K1Y 4G2
- Capital North Therapeutics Res /ID# 134835
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Owen Sound, Ontario, Canada, N4K 1S4
- Setty, Owen Sound, CA /ID# 134189
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Peterborough, Ontario, Canada, K9J 7B3
- The Medical Centre /ID# 134833
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Toronto, Ontario, Canada, M3H 5S4
- Involved Medicine /ID# 163880
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Toronto, Ontario, Canada, M9V 4B8
- Dr. Samuel K Silverberg /ID# 136496
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Quebec
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Montreal, Quebec, Canada, H2L 1S6
- Institut de Rhum. de Montreal /ID# 135289
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital /ID# 204168
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Montreal, Quebec, Canada, H3T 1Y3
- PSS Medical Inc. /ID# 134193
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Montréal, Quebec, Canada, H4N 1C6
- Clinique de Rhumatologie de Montréal /ID# 162186
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Rimouski, Quebec, Canada, G5L 8W1
- Ctr. de Rheum de l'est du QC /ID# 135410
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Westmount, Quebec, Canada, H3Z 2Z3
- Rheum Disease Ctr of Montreal /ID# 135372
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 3H3
- Dr. Latha Naik /ID# 135813
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Adalimumab subjects
Subjects starting Adalimumab treatment at time of enrollment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS)
Tidsramme: From Month 0 to Month 6
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This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.
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From Month 0 to Month 6
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Change in Financial Loss
Tidsramme: From Month 0 to Month 6
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This is patient reported assessment of financial burden of RA.
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From Month 0 to Month 6
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Rheumatoid Arthritis-Work Instability (RA-WIS)
Tidsramme: From Month 0 to Month 12, 18 and 24
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This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.
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From Month 0 to Month 12, 18 and 24
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Change in the Financial Loss
Tidsramme: From Month 0 to Month 12, 18 and 24
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This is patient reported assessment of financial burden of RA.
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From Month 0 to Month 12, 18 and 24
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Change in patient pain
Tidsramme: From Month 0 to Month 24
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Pain is assessed using Visual Analogue Scale (VAS)
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From Month 0 to Month 24
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Change in Tender Joint Count (TJC)
Tidsramme: From Month 0 to Month 24
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This is assessed by the physician.
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From Month 0 to Month 24
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Change in Disease Activity Score (DAS) 28
Tidsramme: From Month 0 to Month 24
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Disease activity assessment is done by the physician.
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From Month 0 to Month 24
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Change in patient assessment of Global Disease Activity
Tidsramme: From Month 0 to Month 24
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It is assessed using VAS.
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From Month 0 to Month 24
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Change in Swollen Joint Count (SJC)
Tidsramme: From Month 0 to Month 24
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This is assessed by the physician.
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From Month 0 to Month 24
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Change in physician's assessment of Global Disease Activity
Tidsramme: From Month 0 to Month 24
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It is assessed using VAS.
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From Month 0 to Month 24
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Change in Health Assessment Questionnaire (HAQ)
Tidsramme: From Month 0 to Month 24
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This is patient reported functional assessment.
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From Month 0 to Month 24
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Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR)
Tidsramme: From Month 0 to Month 24
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CRP/ESR values are measured as an inflammatory parameter.
Low CRP and ESR values mean less inflammation.
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From Month 0 to Month 24
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Rate of Remission per Disease Activity Scale (DAS) 28
Tidsramme: From Month 0 to Month 24
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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.
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From Month 0 to Month 24
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Rate of Achieving Low Disease Activity (LDA) per Disease Activity Score (DAS) 28
Tidsramme: From Month 0 to Month 24
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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.
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From Month 0 to Month 24
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Rate of Remission Per Clinical Disease Activity Index (CDAI)
Tidsramme: From Month 0 to Month 24
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The CDAI is used to evaluate disease activity in patients with Rheumatoid Arthritis.
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From Month 0 to Month 24
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Rate of Achieving Low Disease Activity (LDA) per CDAI
Tidsramme: From Month 0 to Month 24
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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.
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From Month 0 to Month 24
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Rate of Remission per Simplified Disease Activity Index (SDAI)
Tidsramme: From Month 0 to Month 24
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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.
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From Month 0 to Month 24
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Rate of Achieving Low Disease Activity (LDA) per SDAI
Tidsramme: From Month 0 to Month 24
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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.
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From Month 0 to Month 24
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. januar 2015
Primær færdiggørelse (Faktiske)
6. marts 2020
Studieafslutning (Faktiske)
6. marts 2020
Datoer for studieregistrering
Først indsendt
9. februar 2015
Først indsendt, der opfyldte QC-kriterier
9. februar 2015
Først opslået (Skøn)
12. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P14-455
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Rheumatoid arthritis
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Janssen Research & Development, LLCTrukket tilbageAktiv reumatoid arthritis; Rheumatoid arthritis
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Hamad Medical CorporationUkendtRHEUMATOID ARTHRITISQatar
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Richard Burt, MDAfsluttet
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Healthcare Homoeo Charitable SocietyUkendtRheumatoid arthritis.Indien
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Federal University of São PauloAfsluttetRheumatoid arthritis.Brasilien
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Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUkendt- Rheumatoid arthritisBrasilien
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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University of SalfordAfsluttetRheumatoid arthritis | Håndslidgigt | Inflammatorisk arthritisDet Forenede Kongerige
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Link America, Inc.AfsluttetSlidgigt | Rheumatoid arthritis | Post-traumatisk arthritisForenede Stater