Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)

Rheumatoid Arthritis Clinical Trial

— PASSION  

Official title:

A Post-Marketing Observational Study (PMOS) to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With Rheumatoid Arthritis (PASSION Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383421
• Other study ID #: P12-072
• Status: Completed
• Phase: N/A
• First received: June 26, 2011
• Last updated: April 27, 2016
• Start date: September 2011
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de SaludAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCzech Republic: State Institute for Drug ControlUnited States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsSlovakia: State Institute for Drug ControlPortugal: National Pharmacy and Medicines InstituteGermany: Ministry of HealthSpain: Ministry of Health and ConsumptionUnited Kingdom: Department of HealthNetherlands: Medicines Evaluation Board (MEB)Israel: Ministry of HealthCanada: Health CanadaGreece: Ministry of Health and WelfareFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

Post-marketing observational study to determine the effectiveness and patient satisfaction with adalimumab treatment in patients with Rheumatoid Arthritis in relation to utilization of a Patient Support Program (PSP).

Description:

This study is a non-confirmatory study to explore and describe the effectiveness of adalimumab on Rheumatoid Arthritis (RA) treatment course and patient satisfaction over time in context with utilization of a Patient Support Program (PSP). The main objectives are to examine the effectiveness of adalimumab treatment with respect to PSPs by means of Health Assessment Questionnaire Disability Index (HAQ-DI), Disease Activity Score (DAS28) results, and European League Against Rheumatism (EULAR) response criteria, as well as to evaluate the contribution of PSP to disease control, treatment continuation over time, patient's satisfaction, and PSP utilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1036
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Male or female aged at least 18 years that has been newly prescribed adalimumab therapy according to the local product label, with the first dose corresponding to the Enrollment/Baseline visit.

• Patient with a diagnosis of moderate to severe Rheumatoid Arthritis (RA), who has had insufficient response to one or more Disease-Modifying Antirheumatic Drugs (DMARDs), and has a prescription of adalimumab according to the local regulations.

• Patients should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB (per local requirements and according to the local product label).

• Patients must be able and willing to provide written authorization to disclose and use personal health information (and informed consent where applicable) and comply with the requirements of this study protocol as well as agree to data being collected and provided to AbbVie.

Exclusion Criteria:

• Patients should not be enrolled if they cannot be treated in accordance with the local adalimumab product label.

• Patients treated with > 1 prior biologic Disease-modifying Anti-rheumatic Drug (DMARD) for Rheumatoid Arthritis (RA). Any prior treatment with adalimumab is prohibited.

Study Design

N/A

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 103416	Adelaide
Australia	Site Reference ID/Investigator# 55262	Campsie, Sydney
Australia	Site Reference ID/Investigator# 56428	Coffs Harbour
Australia	Site Reference ID/Investigator# 55263	Fitzroy
Australia	Site Reference ID/Investigator# 56427	Geelong
Australia	Site Reference ID/Investigator# 56426	Shenton Park
Australia	Site Reference ID/Investigator# 103415	West Perth
Belgium	Site Reference ID/Investigator# 56989	Aalst
Belgium	Site Reference ID/Investigator# 59366	Aalst
Belgium	Site Reference ID/Investigator# 56984	Bruges
Belgium	Site Reference ID/Investigator# 57011	Brussels
Belgium	Site Reference ID/Investigator# 57020	Brussels
Belgium	Site Reference ID/Investigator# 57019	Ceroux-Mousty
Belgium	Site Reference ID/Investigator# 57023	Champion
Belgium	Site Reference ID/Investigator# 56988	Erembodegem
Belgium	Site Reference ID/Investigator# 56990	Genk
Belgium	Site Reference ID/Investigator# 57004	Genk
Belgium	Site Reference ID/Investigator# 56987	Gistel
Belgium	Site Reference ID/Investigator# 60302	Heist-op-den-Berg
Belgium	Site Reference ID/Investigator# 57012	Heusy
Belgium	Site Reference ID/Investigator# 57010	La Louviere
Belgium	Site Reference ID/Investigator# 57006	Mechelen
Belgium	Site Reference ID/Investigator# 57014	Mons
Belgium	Site Reference ID/Investigator# 57008	Nalinnes
Belgium	Site Reference ID/Investigator# 73613	Neupre Plainevaux
Belgium	Site Reference ID/Investigator# 56991	Oudenaarde
Belgium	Site Reference ID/Investigator# 59022	Roeselare
Belgium	Site Reference ID/Investigator# 56992	Sint-Niklaas
Belgium	Site Reference ID/Investigator# 57003	Sint-Niklaas
Belgium	Site Reference ID/Investigator# 57007	Waterloo
Belgium	Site Reference ID/Investigator# 56985	Wilrijk
Czech Republic	Site Reference ID/Investigator# 55810	Brno
Czech Republic	Site Reference ID/Investigator# 55812	Bruntal
Czech Republic	Site Reference ID/Investigator# 55807	Chomutov
Czech Republic	Site Reference ID/Investigator# 55817	Hlucin
Czech Republic	Site Reference ID/Investigator# 55815	Jihlava
Czech Republic	Site Reference ID/Investigator# 55809	Kromeriz
Czech Republic	Site Reference ID/Investigator# 55811	Ostrava
Czech Republic	Site Reference ID/Investigator# 55816	Pardubice
Czech Republic	Site Reference ID/Investigator# 101335	Praha
Czech Republic	Site Reference ID/Investigator# 55814	Uherske Hradiste
Czech Republic	Site Reference ID/Investigator# 55806	Zlin
France	Site Reference ID/Investigator# 55499	Amiens
France	Site Reference ID/Investigator# 55505	Caen
France	Site Reference ID/Investigator# 55493	Cahors
France	Site Reference ID/Investigator# 55511	Clermont-Ferrand
France	Site Reference ID/Investigator# 55509	Dreux
France	Site Reference ID/Investigator# 55502	Lille
France	Site Reference ID/Investigator# 55507	Nantes Cedex 1
France	Site Reference ID/Investigator# 55504	Paris Cedex 10
France	Site Reference ID/Investigator# 55496	Vandoeuvre les Nancy
Germany	Site Reference ID/Investigator# 56686	Bernau
Germany	Site Reference ID/Investigator# 56691	Blaubeuren
Germany	Site Reference ID/Investigator# 56692	Duesseldorf
Germany	Site Reference ID/Investigator# 56891	Goslar
Germany	Site Reference ID/Investigator# 56688	Haldensleben
Germany	Site Reference ID/Investigator# 56687	Halle
Germany	Site Reference ID/Investigator# 56685	Hoyerswerda
Germany	Site Reference ID/Investigator# 56690	Offenburg
Germany	Site Reference ID/Investigator# 56693	Ratingen
Germany	Site Reference ID/Investigator# 56689	Rostock
Germany	Site Reference ID/Investigator# 56862	Seesen
Greece	Site Reference ID/Investigator# 122695	Athens
Greece	Site Reference ID/Investigator# 55427	Athens
Greece	Site Reference ID/Investigator# 55429	Athens
Greece	Site Reference ID/Investigator# 71619	Athens
Greece	Site Reference ID/Investigator# 55422	Ioanina
Greece	Site Reference ID/Investigator# 55425	Larissa
Greece	Site Reference ID/Investigator# 122715	Thessaloniki
Greece	Site Reference ID/Investigator# 55424	Thessaloniki
Greece	Site Reference ID/Investigator# 55426	Thessaloniki
Israel	Site Reference ID/Investigator# 55564	Haifa
Israel	Site Reference ID/Investigator# 75806	Haifa
Israel	Site Reference ID/Investigator# 55568	Petah Tikva
Israel	Site Reference ID/Investigator# 55569	Ramat Gan
Israel	Site Reference ID/Investigator# 55566	Tel Aviv
Israel	Site Reference ID/Investigator# 55567	Zerifin
Mexico	Site Reference ID/Investigator# 55265	Chihuahua
Mexico	Site Reference ID/Investigator# 55267	Chihuahua
Mexico	Site Reference ID/Investigator# 55269	Guadalajara, Jalisco
Mexico	Site Reference ID/Investigator# 55268	Mexico City
Mexico	Site Reference ID/Investigator# 76153	Monterrey, NL
Netherlands	Site Reference ID/Investigator# 55283	Alkmaar
Netherlands	Site Reference ID/Investigator# 55285	Gouda
Netherlands	Site Reference ID/Investigator# 55287	Leeuwarden
Netherlands	Site Reference ID/Investigator# 55284	Rotterdam
Portugal	Site Reference ID/Investigator# 55204	Lisbon
Portugal	Site Reference ID/Investigator# 55199	Ponte de Lima
Portugal	Site Reference ID/Investigator# 55202	Viseu
Puerto Rico	Site Reference ID/Investigator# 123075	Bayamon
Puerto Rico	Site Reference ID/Investigator# 55487	Caguas
Puerto Rico	Site Reference ID/Investigator# 78453	Mayaguez
Puerto Rico	Site Reference ID/Investigator# 55485	Ponce
Puerto Rico	Site Reference ID/Investigator# 54942	Vega Baja
Slovakia	Site Reference ID/Investigator# 55144	Banska Bystrica
Slovakia	Site Reference ID/Investigator# 55150	Bratislava
Slovakia	Site Reference ID/Investigator# 55147	Kosice
Slovakia	Site Reference ID/Investigator# 55148	Kosice
Slovakia	Site Reference ID/Investigator# 55145	Piestany
Slovakia	Site Reference ID/Investigator# 55146	Piestany
Slovakia	Site Reference ID/Investigator# 55149	Piestany
Slovakia	Site Reference ID/Investigator# 55152	Piestany
Switzerland	Site Reference ID/Investigator# 65962	Chur
Switzerland	Site Reference ID/Investigator# 74855	Clarens - Montreux
Switzerland	Site Reference ID/Investigator# 74856	Lausanne
United Kingdom	Site Reference ID/Investigator# 55434	Barnsley
United Kingdom	Site Reference ID/Investigator# 55438	Basingstoke, Hants
United Kingdom	Site Reference ID/Investigator# 61696	Bury St. Edmunds, Suffolk
United Kingdom	Site Reference ID/Investigator# 55433	Cambridge
United Kingdom	Site Reference ID/Investigator# 55435	Dewsbury
United Kingdom	Site Reference ID/Investigator# 55436	Glasgow
United Kingdom	Site Reference ID/Investigator# 55431	Harrogate
United Kingdom	Site Reference ID/Investigator# 55514	Leicester
United Kingdom	Site Reference ID/Investigator# 119776	London
United Kingdom	Site Reference ID/Investigator# 119777	Warrington
United Kingdom	Site Reference ID/Investigator# 57306	Westcliff on Sea
United Kingdom	Site Reference ID/Investigator# 119775	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Australia,  Belgium,  Czech Republic,  France,  Germany,  Greece,  Israel,  Mexico,  Netherlands,  Portugal,  Puerto Rico,  Slovakia,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Disease activity score DAS28 , Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), ACR 20/50/70, EULAR moderate and good responses		Baseline and Weeks 12, 24, 36, 52, 64 and 78/Premature Discontinuation	No
Other	Health outcomes assessments, including HAQ-DI, Work Productivity and Activity Impairment (WPAI), Compliance Questionnaire Rheumatology (CQR), and Treatment Satisfaction Questionnaire for Medication (TSQM) scores.		Baseline and Weeks 12, 24, 36, 52, 64 and 78/Premature Discontinuation	No
Other	Expectation regarding PSP and health management via Patient Activation Measure (PAM-13).		Baseline and Weeks 12, 24, 36, 52, 64 and 78/Premature Discontinuation	No
Other	Change in patient perceptions as measured by the Beliefs about Medicines Questionnaire (BMQ).		Baseline and Weeks 12, 24, 36, 52, 64 and 78/Premature Discontinuation	No
Other	Satisfaction with PSP as measured by PSP satisfaction assessment.		Baseline and Weeks 12, 24, 36, 52, 64 and 78/Premature Discontinuation	No
Primary	Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 78 compared to Baseline (improve of at least 0.22 in HAQ-DI).		Week 78	No
Secondary	Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 12 compared to Baseline (improve of at least 0.22 in HAQ-DI).		Week 12	No
Secondary	Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 24 compared to Baseline (improve of at least 0.22 in HAQ-DI).		Week 24	No
Secondary	Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 36 compared to Baseline (improve of at least 0.22 in HAQ-DI).		Week 36	No
Secondary	Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 52 compared to Baseline (improve of at least 0.22 in HAQ-DI).		Week 52	No
Secondary	Percentage of patients achieving Minimal Clinically Important Difference (MCID) in HAQ-DI at Week 64 compared to Baseline (improve of at least 0.22 in HAQ-DI).		Week 64	No

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