Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608112
• Other study ID #: ML29256
• Status: Completed
• Start date: December 31, 2015
• Est. completion date: July 26, 2018

Study information

• Verified date: February 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate
Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.
• Tocilizumab
Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.

Locations

Country	Name	City	State
France	Hopital Nord; Rhumatologie	Amiens
France	Ch D Ardeche Meridionale; Medecine A2	Aubenas
France	Ch De Belfort; Rhumatologie	Belfort
France	Institut Calot Helio Marin; Rhumatologie	Berck
France	Hopital Jean Minjoz	Besancon
France	Hopital Pellegrin; Rhumatologie	Bordeaux
France	Hopital La Cavale Blanche; Rhumatologie	Brest
France	Hopital Cote De Nacre; Rhumatologie	Caen
France	CH Jean Rougier; Rhumato Reed Fonctionnelle	Cahors
France	Infirmerie Protestante; Medecine interne Cancerologie	Caluire
France	Hopital Pierre Nouveau;Medecine C Unite Rhumatologie	Cannes
France	Cabinet medical,Rhumatologie	Castelnaudary
France	Hopital Trousseau; Rhumatologie	Chambray Les Tours
France	HIA PERCY; Medecine Interne	Clamart
France	Hopital Gabriel Montpied; Service de Rhumatologie	Clermont-ferrand
France	CH compiègne	Compiègne
France	Centre Hospitalier Alpes	Contamine Sur Arve
France	CH Sud Francilien; Rhumatologie	Corbeil Essonnes
France	Chu Sud Francilien; Rhumatologie	Corbeil-essones
France	Hopital Henri Mondor; Rhumatologie	Creteil
France	CH de Dax	Dax
France	Ch De Douai; Medecine Polyvalente	Dechy
France	Ch Louis Pasteur; Rhumato Med Interne Neurologie	Dole
France	Hopital Victor Jousselin; Rhumatologie 4EME Sud	Druex
France	Hopital Sud; Rhumatologie	Echirolles
France	Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente	GAP
France	Cabinet Medical	Haguenau
France	Cabinet Medical.	Haguenau
France	Cabinet medical; Rhumatologie	Joue Les Tours
France	CH de Juvisy sur Orge; Consult. externes	Juvisy sur Orge
France	Cabinet	La Madeleine
France	Hopital La Source; Rhumatologie	La Source
France	Ch De Laon; Medecine Interne	Laon
France	Ch Louis Pasteur; Medecine B3	Le Coudray
France	CH de Bicêtre; Rhumatologie	Le Kremlin Bicetre
France	Hopital Emile Roux; Rhumatologie	Le Puy En Velay
France	Cabinet medical.	Lille
France	Hopital B Roger Salengro; Rhumatologie	Lille
France	Cabinet de Rhumatologie MSP de Beaublanc	Limoges
France	Hopital Dupuytren; Rhumatologie	Limoges
France	Ctre De Rhumato Lyon Presqu ile	Lyon
France	Hopital Edouard Herriot; Pavillon F Rhumatologie	Lyon
France	Fondation Hopital Saint Joseph; Rhumatologie	Marseille
France	Hopital Sainte Marguerite; Rhumatologie	Marseille
France	CH Annecy Genevois; Rhumatologie	Metz Tessy
France	GHI Le Raincy Montfermeil	Montfermeil
France	Cabinet Medical	Montpellier
France	Cabinet medical; Cabinet medical	Montpellier
France	Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen	Montpellier
France	Hopital Lapeyronie; Immunologie Rhumatologie	Montpellier
France	Ch Des Pays De Morlaix; Medecine I	Morlaix
France	Cabinet Medical	Nice
France	Hopital Pasteur; Rhumatologie	Nice Cedex 1
France	Maison de Santé; MSP	Nogent Le Rotrou
France	Ch Pitie Salpetriere; Rhumatologie	Paris
France	Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie	Paris
France	Ch Lyon Sud; Rhumato Secteur Jules Courmont	Pierre Benite
France	Cabinet	Poitiers
France	Chu La Miletrie; Rhumatologie	Poitiers
France	Hopital Sud Anne de Bretagne; Rhumatologie	Rennes
France	Hôpital Victor Provo	Roubaix
France	Cabinet Medical	Saint Lo
France	Centre Hopsitalier Saint Nazaire; Medecine Polyvalente	Saint Nazaire
France	Centre Hospitalier Saint Quentin	Saint Quentin
France	CH de Saint Quentin	Saint Quentin
France	Centre medical des coteaux; Rhumatologie	Saintes
France	Centre Medico-Chirurgical de Touraine	St Cyr Sur Loire
France	Hopital Instruction Armees Begin; Rhumatologie	St Mande
France	Hopital Nord; Rhumatologie	St Priest En Jarez
France	Hopital Hautepierre; Rhumatologie	Strasbourg
France	Hopitaux du Leman site Thonon; Rhumatologie	Thonon Les Bains
France	Cabinet de Rhumatologie	Toulouse
France	Hopital Purpan; Rhumatologie	Toulouse
France	Cabinet Medical	Tours
France	Cabinet Medical	Valenciennes
France	Hopitaux De Brabois; Rhumatologie	Vandoeuvre-les-nancy
France	Hopital; Pole geriatrique	Villeneuve sur Lot

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Were on TCZ SC for a Period of 12 Months		Up to 12 Months
Secondary	Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP)		Months 3, 6, 12, and 18
Secondary	Simple Disease Activity Index (SDAI)		Months 3, 6, 12, and 18
Secondary	Clinical Disease Activity Index (CDAI)		Months 3, 6, 12, and 18
Secondary	Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response		Months 3, 6, 12, and 18
Secondary	Percentage of Participants Who Were on TCZ SC for a Period of 6 Months		Up to 6 Months
Secondary	Percentage of Participants Who Were on TCZ SC for a Period of 18 Months		Up to 18 Months
Secondary	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		Up to 18 Months
Secondary	Dose of Concomitant Steroids After Introduction of TCZ SC		Months 6, 12, and 18
Secondary	Number of Participants with Adherence to TCZ SC Using the Compliance Questionnaire of Rheumatology 5 (CQR5) and Participants Diary Data		Months 6, 12, and 18
Secondary	Percentage of Participants with Definitive Discontinuation of Treatment		Up to 18 Months
Secondary	Percentage of Participants Performing All Visits at Hospital/Office Based Rheumatologist		Up to 18 Months
Secondary	Percentage of Participants Taking Sick Leaves or Getting Hospitalized Due to RA		Up to 18 Months
Secondary	Tender Joints Count		Months 3, 6, 12, and 18
Secondary	Swollen Joints Count		Months 3, 6, 12, and 18
Secondary	Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR)		Months 3, 6, 12, and 18