Clinical trial NCT02608112: Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year
Official title: Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with moderate to severe RA not previously treated with TCZ (IV or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another csDMARD.

Brief summary: This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* Participants at least 18 years old
* Participants with moderate to severe RA not previously treated with TCZ (Intravenous \[IV\] or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csDMARD)

Exclusion Criteria:

* Participants taking part in a clinical trial on RA at the time of inclusion
* Participants with a contra-indication to TCZ SC therapy

Primary outcomes:
measure: Percentage of Participants Who Were on TCZ SC for a Period of 12 Months
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP)
timeFrame: Months 3, 6, 12, and 18
measure: Simple Disease Activity Index (SDAI)
timeFrame: Months 3, 6, 12, and 18
measure: Clinical Disease Activity Index (CDAI)
timeFrame: Months 3, 6, 12, and 18
measure: Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response
timeFrame: Months 3, 6, 12, and 18
measure: Percentage of Participants Who Were on TCZ SC for a Period of 6 Months
timeFrame: Up to 6 Months
measure: Percentage of Participants Who Were on TCZ SC for a Period of 18 Months
timeFrame: Up to 18 Months
measure: Percentage of Participants who were on TCZ SC at 6, 12 and 18 Months Among 2 Subgroups: Participants Administered TCZ SC as Monotherapy and Participants Administered TCZ SC with Methotrexate or csDMARD
timeFrame: Up to 18 Months
measure: Dose of Concomitant Steroids After Introduction of TCZ SC
timeFrame: Months 6, 12, and 18
measure: Number of Participants with Adherence to TCZ SC Using the Compliance Questionnaire of Rheumatology 5 (CQR5) and Participants Diary Data
timeFrame: Months 6, 12, and 18
measure: Percentage of Participants with Definitive Discontinuation of Treatment
timeFrame: Up to 18 Months
measure: Percentage of Participants Performing All Visits at Hospital/Office Based Rheumatologist
timeFrame: Up to 18 Months
measure: Percentage of Participants Taking Sick Leaves or Getting Hospitalized Due to RA
timeFrame: Up to 18 Months
measure: Tender Joints Count
timeFrame: Months 3, 6, 12, and 18
measure: Swollen Joints Count
timeFrame: Months 3, 6, 12, and 18
measure: Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR)
timeFrame: Months 3, 6, 12, and 18
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hopital Nord; Rhumatologie
city: Aubenas
country: France
facility: Ch D Ardeche Meridionale; Medecine A2
city: Belfort
country: France
facility: Ch De Belfort; Rhumatologie
city: Berck
country: France
facility: Institut Calot Helio Marin; Rhumatologie
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Hopital Pellegrin; Rhumatologie
city: Brest
country: France
facility: Hopital La Cavale Blanche; Rhumatologie
city: Caen
country: France
facility: Hopital Cote De Nacre; Rhumatologie
city: Cahors
country: France
facility: CH Jean Rougier; Rhumato Reed Fonctionnelle
city: Caluire
country: France
facility: Infirmerie Protestante; Medecine interne Cancerologie
city: Cannes
country: France
facility: Hopital Pierre Nouveau;Medecine C Unite Rhumatologie
city: Castelnaudary
country: France
facility: Cabinet medical,Rhumatologie
city: Chambray Les Tours
country: France
facility: Hopital Trousseau; Rhumatologie
city: Clamart
country: France
facility: HIA PERCY; Medecine Interne
city: Clermont-ferrand
country: France
facility: Hopital Gabriel Montpied; Service de Rhumatologie
city: Compiègne
country: France
facility: CH compiègne
city: Contamine Sur Arve
country: France
facility: Centre Hospitalier Alpes
city: Corbeil Essonnes
country: France
facility: CH Sud Francilien; Rhumatologie
city: Corbeil-essones
country: France
facility: Chu Sud Francilien; Rhumatologie
city: Creteil
country: France
facility: Hopital Henri Mondor; Rhumatologie
city: Dax
country: France
facility: CH de Dax
city: Dechy
country: France
facility: Ch De Douai; Medecine Polyvalente
city: Dole
country: France
facility: Ch Louis Pasteur; Rhumato Med Interne Neurologie
city: Druex
country: France
facility: Hopital Victor Jousselin; Rhumatologie 4EME Sud
city: Echirolles
country: France
facility: Hopital Sud; Rhumatologie
city: GAP
country: France
facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
city: Haguenau
country: France
facility: Cabinet Medical.
city: Haguenau
country: France
facility: Cabinet Medical
city: Joue Les Tours
country: France
facility: Cabinet medical; Rhumatologie
city: Juvisy sur Orge
country: France
facility: CH de Juvisy sur Orge; Consult. externes
city: La Madeleine
country: France
facility: Cabinet
city: La Source
country: France
facility: Hopital La Source; Rhumatologie
city: Laon
country: France
facility: Ch De Laon; Medecine Interne
city: Le Coudray
country: France
facility: Ch Louis Pasteur; Medecine B3
city: Le Kremlin Bicetre
country: France
facility: CH de Bicêtre; Rhumatologie
city: Le Puy En Velay
country: France
facility: Hopital Emile Roux; Rhumatologie
city: Lille
country: France
facility: Hopital B Roger Salengro; Rhumatologie
city: Lille
country: France
facility: Cabinet medical.
city: Limoges
country: France
facility: Hopital Dupuytren; Rhumatologie
city: Limoges
country: France
facility: Cabinet de Rhumatologie MSP de Beaublanc
city: Lyon
country: France
facility: Ctre De Rhumato Lyon Presqu ile
city: Lyon
country: France
facility: Hopital Edouard Herriot; Pavillon F Rhumatologie
city: Marseille
country: France
facility: Hopital Sainte Marguerite; Rhumatologie
city: Marseille
country: France
facility: Fondation Hopital Saint Joseph; Rhumatologie
city: Metz Tessy
country: France
facility: CH Annecy Genevois; Rhumatologie
city: Montfermeil
country: France
facility: GHI Le Raincy Montfermeil
city: Montpellier
country: France
facility: Cabinet medical; Cabinet medical
city: Montpellier
country: France
facility: Cabinet Medical
city: Montpellier
country: France
facility: Hopital Lapeyronie; Immunologie Rhumatologie
city: Montpellier
country: France
facility: Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen
city: Morlaix
country: France
facility: Ch Des Pays De Morlaix; Medecine I
city: Nice Cedex 1
country: France
facility: Hopital Pasteur; Rhumatologie
city: Nice
country: France
facility: Cabinet Medical
city: Nogent Le Rotrou
country: France
facility: Maison de Santé; MSP
city: Paris
country: France
facility: Ch Pitie Salpetriere; Rhumatologie
city: Paris
country: France
facility: Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Rhumato Secteur Jules Courmont
city: Poitiers
country: France
facility: Cabinet
city: Poitiers
country: France
facility: Chu La Miletrie; Rhumatologie
city: Rennes
country: France
facility: Hopital Sud Anne de Bretagne; Rhumatologie
city: Roubaix
country: France
facility: Hôpital Victor Provo
city: Saint Lo
country: France
facility: Cabinet Medical
city: Saint Nazaire
country: France
facility: Centre Hopsitalier Saint Nazaire; Medecine Polyvalente
city: Saint Quentin
country: France
facility: Centre Hospitalier Saint Quentin
city: Saint Quentin
country: France
facility: CH de Saint Quentin
city: Saintes
country: France
facility: Centre medical des coteaux; Rhumatologie
city: St Cyr Sur Loire
country: France
facility: Centre Medico-Chirurgical de Touraine
city: St Mande
country: France
facility: Hopital Instruction Armees Begin; Rhumatologie
city: St Priest En Jarez
country: France
facility: Hopital Nord; Rhumatologie
city: Strasbourg
country: France
facility: Hopital Hautepierre; Rhumatologie
city: Thonon Les Bains
country: France
facility: Hopitaux du Leman site Thonon; Rhumatologie
city: Toulouse
country: France
facility: Cabinet de Rhumatologie
city: Toulouse
country: France
facility: Hopital Purpan; Rhumatologie
city: Tours
country: France
facility: Cabinet Medical
city: Valenciennes
country: France
facility: Cabinet Medical
city: Vandoeuvre-les-nancy
country: France
facility: Hopitaux De Brabois; Rhumatologie
city: Villeneuve sur Lot
country: France
facility: Hopital; Pole geriatrique
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hilliquin P, Barnetche T, Baillet A, Flipo RM, Lespessailles E, Roux C, Fardellone P, Gilbert-Marceau A, Idier I, Constantin A, Shipley E, Baudens G, Saraux A. Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study. Rheumatol Ther. 2021 Mar;8(1):95-108. doi: 10.1007/s40744-020-00253-0. Epub 2020 Nov 20.