Clinical trial NCT02925338: National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
Official title: OBSERVATOIRE NATIONAL D'UTILISATION D'INFLECTRA™ EN VIE RÉELLE.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Ulcerative Colitis
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 1431
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.

Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis

Brief summary: National, prospective, multicentre observational study designed for eligible patients treated with Inflectra.

Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.
* Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis Patients (or their legal representatives) who have received information (verbally and in writing) about the study and agreed to take part in it.
* Patients who have given their agreement for their clinical data and their medical file to be accessed by signing the information leaflet.

Exclusion Criteria:

* Patients who refuse access to their medical file for collection of: their medical data
* Patients not treated with Inflectra™.
* Patients treated with Inflectra™ for psoriasis.
* Patients with a past history of hypersensitivity to infliximab, to other murine proteins or to one of the excipients in Inflectra™.
* Patients with tuberculosis or any other severe infection such as sepsis, abscess or opportunistic infection .
* Patients with moderate to severe heart failure (NYHA III/IV)

Primary outcomes:
measure: Percentage of Participants Without Treatment Failure During 2-Years of Observation
timeFrame: 2 years post inclusion in the study
measure: Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy
timeFrame: Data collected and recorded at study inclusion visit
measure: Time Between Diagnosis and Inclusion in Study
timeFrame: Data collected and recorded at study inclusion visit
measure: Time Between Diagnosis and the First Inflectra Infusion
timeFrame: Data collected and recorded at study inclusion visit
measure: Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study
timeFrame: Data collected and recorded at study inclusion visit
measure: Number of Participants With Reasons for Discontinuation of Previous Biotherapy
timeFrame: Data collected and recorded at study inclusion visit
measure: Duration of Previous Biotherapies
timeFrame: Data collected and recorded at study inclusion visit
measure: Mean of Number of Doses Administered in Previous Biotherapy
timeFrame: Data collected and recorded at study inclusion visit
measure: Last Dosage Administered of a Previous Biotherapy
timeFrame: Data collected and recorded at study inclusion visit
measure: Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra
timeFrame: Data collected and recorded at study inclusion visit
Secondary outcomes:
measure: Physician Global Assessment (PGA) of Disease for RA, SpA and PA
timeFrame: 24 months
measure: Mean Administered Dose of Inflectra (in mg)
timeFrame: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
measure: Mean Administered Posology of Inflectra (in mg/kg)
timeFrame: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
measure: Cumulative Dose
timeFrame: Inclusion visit up to 6-Month visit, Inclusion visit up to 12-Month visit, Inclusion visit up to 18-Month visit, and Inclusion visit up to 24-Month visit
measure: Mean Infusion Time
timeFrame: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
measure: Mean Time Between Infusions
timeFrame: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
measure: Mean Duration of Post-infusion Monitoring at the Hospital
timeFrame: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
measure: Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Mayo Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Pediatric Ulcerative Colitis Activity Index (PUCAI) Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Colitis Endoscopic Index of Severity (UCEIS) Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Harvey-Bradshaw Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Simple Disease Activity Index (SDAI) Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Health Assessment Questionnaire (HAQ) Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Absolute Variation in Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) Score Compared With Baseline at Month 6, 12, 18, and 24
timeFrame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
measure: Cook and Medley Score at Baseline
timeFrame: Baseline (data recorded at inclusion visit)
measure: Stress Score
timeFrame: Baseline (inclusion visit) up to Month 12
measure: General Anxiety Disorder (GAD7) Score
timeFrame: Baseline (inclusion visit) through post each infusion (during 2 years)
measure: Number of Participants With Immunogenicity Assay at Inclusion Visit
timeFrame: Baseline (data recorded at inclusion visit)
measure: Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit
timeFrame: Baseline (data recorded at inclusion visit)
measure: Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit
timeFrame: Baseline (data recorded at inclusion visit)
measure: Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit
timeFrame: Baseline (data recorded at inclusion visit)
measure: Infliximab Trough Level (IFX-TL) at Inclusion Visit
timeFrame: Before infusion at baseline (data recorded at inclusion visit)
measure: Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit)
timeFrame: Inclusion visit up to 6-Month visit, 6-Month visit up to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
measure: Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit)
timeFrame: Inclusion visit up to 6-Month visit, 6-Month visit up to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
measure: Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit)
timeFrame: Before every infusion occurred during: inclusion visit up to 6-Month visit; 6-Month visit up to 12-Month visit; 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre
state: Alsace
city: Nantes cedex 1
country: France
facility: Service de rhumatologie - CHU Nantes, Hopital Hotel Dieu
state: Loire-atlantique
city: Clermont Ferrand Cedex
country: France
facility: Centre Hospitalier Universitaire Gabriel Montpied
state: Puy-de-dôme
city: Aix En Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Aix-En-Provence
country: France
facility: Chi Aix Pertuis
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Besancon
country: France
facility: Centre Hospitalier Regional de Besancon, Service de Gastrologie
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Bordeaux Cedex
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
city: Bordeaux
country: France
facility: Hopital Saint Andre - Chu Bordeaux
city: Bordeaux
country: France
facility: CHU - Hôpital Pellegrin-tripode
city: Bruges
country: France
facility: Clinique Jean Vila
city: Bruges
country: France
facility: Clinique Jean Vilar
city: Caen
country: France
facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
city: Cannes Cedex
country: France
facility: Ch de Cannes Hopital Pierre Nouveau
city: Cannes
country: France
facility: Centre Hospitalier de Cannes Hopital Pierre Nouveau
city: Cannes
country: France
facility: Centre Hospitalier de Cannes
city: Carcassonne
country: France
facility: Centre Hospitalier Carcassonne, Service de Rhumatologie
city: Cholet
country: France
facility: Centre Hospitalier de Cholet Service d'Hépato-Gastro-Entérologie
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Clermont Ferrand
country: France
facility: Centre Hospitalier Estaing, Service de Medicine Interne
city: Clichy
country: France
facility: Hopital Beaujon
city: Contamine Sur Avre
country: France
facility: Centre Hospitalier
city: Creteil
country: France
facility: Chu Henri Mondor
city: Echirolles
country: France
facility: CHU de Grenoble - Hopital Sud
city: GRENOBLE Cedex 9
country: France
facility: Hopital Nord
city: Grenoble
country: France
facility: CHU De Grenoble
city: La Roche Sur Yon
country: France
facility: CHD Vendee
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: Centre Hospitalier de Lille Hopital Roger Salengro
city: Limoges
country: France
facility: CHU Limoges - Hôpital Dupuytren
city: Little Cedex
country: France
facility: Hospital Huriez, CHRU de Lille
city: Lomme
country: France
facility: Hopital Saint Philibert
city: Lyon
country: France
facility: Hopital Edouard Herriot Pav H
city: Metz Tessy
country: France
facility: Centre Hospitalier
city: Montauban Cedex
country: France
facility: CHG Montauban
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre
city: Montpellier
country: France
facility: Centre Hospitalier de Montpellier Hopital Saint Eloi
city: Montpellier
country: France
facility: CHU de Montpellier - Saint Eloi
city: Montpellier
country: France
facility: CHU de MONTPELLIER HOPITAL LAPEYRONIE
city: Montpellier
country: France
facility: CHU
city: Nice Cedex 3
country: France
facility: CHU Nice-Hopital Archet I
city: NICE Cedex 3
country: France
facility: Hopital de l'Archet
city: Nimes
country: France
facility: CHU Nimes
city: Paris Cedex 18
country: France
facility: Hopital Claude Bichat
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hôpital Cochin
city: Pessac Cedex
country: France
facility: Hôpital Haut-Lévêque
city: Pierre Benite Cedex
country: France
facility: Hopital Lyon Sud
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Reims cedex
country: France
facility: Hopital Robert Debre, Service d'Hepato-gastro-enterologie et de Cancerologie Digestive
city: Reims CEDEX
country: France
facility: Hopital Robert Debre, Service D'Hepato-gastro-enterolo
city: Rouen
country: France
facility: CHU de Rouen
city: Rouen
country: France
facility: CHRU Charles Nicolle
city: Saint Etienne
country: France
facility: Service Rhumatologie
city: St Priest En Jarez Cedex
country: France
facility: Hopital Nord
city: St. Priest En Jarez
country: France
facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
city: Talence Cedex
country: France
facility: Fondation Maison Sante Bagatelle, Gastro Enterologie
city: Tarbes
country: France
facility: Centre Hospitalier de la Gespe
city: Thonon les Bains
country: France
facility: Hopital du Leman
city: Thonon Les Bains
country: France
facility: Hopitaux du Leman
city: Toulouse cedex 04
country: France
facility: Hopital Rangueil
city: Toulouse Cedex 09
country: France
facility: Hopital Purpan
city: Toulouse
country: France
facility: Hopital Purpan
city: Troyes
country: France
facility: Hopital des Hauts Clos
city: Vandoeuvre Les Nancy
country: France
facility: Chu Brabois
city: Vitre
country: France
facility: Hopital Saint Nicolas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: