Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year
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
1 other identifier
observational
291
1 country
77
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Typical duration for all trials
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 18, 2015
CompletedStudy Start
First participant enrolled
December 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2018
CompletedFebruary 11, 2020
February 1, 2020
2.6 years
November 16, 2015
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Were on TCZ SC for a Period of 12 Months
Up to 12 Months
Secondary Outcomes (15)
Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP)
Months 3, 6, 12, and 18
Simple Disease Activity Index (SDAI)
Months 3, 6, 12, and 18
Clinical Disease Activity Index (CDAI)
Months 3, 6, 12, and 18
Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response
Months 3, 6, 12, and 18
Percentage of Participants Who Were on TCZ SC for a Period of 6 Months
Up to 6 Months
- +10 more secondary outcomes
Study Arms (1)
Participants with Moderate to Severe RA
Participants with moderate or severe RA, naïve to TCZ treatment (IV or SC), and who have no contra-indication to TCZ SC therapy as per the local label are included.
Interventions
Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.
Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- Participants with a contra-indication to TCZ SC therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Hopital Nord; Rhumatologie
Amiens, 80054, France
Ch D Ardeche Meridionale; Medecine A2
Aubenas, 07205, France
Ch De Belfort; Rhumatologie
Belfort, 90016, France
Institut Calot Helio Marin; Rhumatologie
Berck, 62608, France
Hopital Jean Minjoz
Besançon, 25030, France
Hopital Pellegrin; Rhumatologie
Bordeaux, 33076, France
Hopital La Cavale Blanche; Rhumatologie
Brest, 29609, France
Hopital Cote De Nacre; Rhumatologie
Caen, 14033, France
CH Jean Rougier; Rhumato Reed Fonctionnelle
Cahors, 46005, France
Infirmerie Protestante; Medecine interne Cancerologie
Caluire-et-Cuire, 69300, France
Hopital Pierre Nouveau;Medecine C Unite Rhumatologie
Cannes, 06401, France
Cabinet medical,Rhumatologie
Castelnaudary, 11400, France
Hopital Trousseau; Rhumatologie
Chambray-lès-Tours, 37171, France
HIA PERCY; Medecine Interne
Clamart, 92141, France
Hopital Gabriel Montpied; Service de Rhumatologie
Clermont-Ferrand, 63003, France
CH compiègne
Compiègne, 60200, France
Centre Hospitalier Alpes
Contamine-sur-Arve, 74130, France
Chu Sud Francilien; Rhumatologie
Corbeil-essones, 91106, France
CH Sud Francilien; Rhumatologie
Corbeil-Essonnes, 91106, France
Hopital Henri Mondor; Rhumatologie
Créteil, 94010, France
CH de Dax
Dax, 40107, France
Ch De Douai; Medecine Polyvalente
Dechy, 59187, France
Ch Louis Pasteur; Rhumato Med Interne Neurologie
Dole, 39108, France
Hopital Victor Jousselin; Rhumatologie 4EME Sud
Druex, 28102, France
Hopital Sud; Rhumatologie
Échirolles, 38434, France
Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
Gap, 05000, France
Cabinet Medical.
Haguenau, 67500, France
Cabinet Medical
Haguenau, 67500, France
Cabinet medical; Rhumatologie
Joué-lès-Tours, 37300, France
CH de Juvisy sur Orge; Consult. externes
Juvisy-sur-Orge, 91265, France
Cabinet
La Madeleine, 59110, France
Hopital La Source; Rhumatologie
La Source, 45100, France
Ch De Laon; Medecine Interne
Laon, 02001, France
Ch Louis Pasteur; Medecine B3
Le Coudray, 28630, France
CH de Bicêtre; Rhumatologie
Le Kremlin-Bicêtre, 94275, France
Hopital Emile Roux; Rhumatologie
Le Puy-en-Velay, 43012, France
Hopital B Roger Salengro; Rhumatologie
Lille, 59037, France
Cabinet medical.
Lille, 59800, France
Hopital Dupuytren; Rhumatologie
Limoges, 87042, France
Cabinet de Rhumatologie MSP de Beaublanc
Limoges, 87100, France
Ctre De Rhumato Lyon Presqu ile
Lyon, 69002, France
Hopital Edouard Herriot; Pavillon F Rhumatologie
Lyon, 69437, France
Hopital Sainte Marguerite; Rhumatologie
Marseille, 13274, France
Fondation Hopital Saint Joseph; Rhumatologie
Marseille, 13285, France
CH Annecy Genevois; Rhumatologie
Metz-Tessy, 74370, France
GHI Le Raincy Montfermeil
Montfermeil, 93370, France
Cabinet medical; Cabinet medical
Montpellier, 34000, France
Cabinet Medical
Montpellier, 34070, France
Hopital Lapeyronie; Immunologie Rhumatologie
Montpellier, 34295, France
Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen
Montpellier, 34295, France
Ch Des Pays De Morlaix; Medecine I
Morlaix, 29672, France
Cabinet Medical
Nice, 06000, France
Hopital Pasteur; Rhumatologie
Nice, 06002, France
Maison de Santé; MSP
Nogent-le-Rotrou, 28400, France
Ch Pitie Salpetriere; Rhumatologie
Paris, 75651, France
Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie
Paris, 75960, France
Ch Lyon Sud; Rhumato Secteur Jules Courmont
Pierre-Bénite, 69495, France
Cabinet
Poitiers, 86000, France
Chu La Miletrie; Rhumatologie
Poitiers, 86021, France
Hopital Sud Anne de Bretagne; Rhumatologie
Rennes, 35203, France
Hôpital Victor Provo
Roubaix, 59056, France
Centre Medico-Chirurgical de Touraine
Saint-Cyr-sur-Loire, 37540, France
Cabinet Medical
Saint-Lô, 50000, France
Hopital Instruction Armees Begin; Rhumatologie
Saint-Mandé, 94163, France
Centre Hopsitalier Saint Nazaire; Medecine Polyvalente
Saint-Nazaire, 44606, France
Hopital Nord; Rhumatologie
Saint-Priest-en-Jarez, 42277, France
Centre Hospitalier Saint Quentin
Saint-Quentin, 02321, France
CH de Saint Quentin
Saint-Quentin, 2100, France
Centre medical des coteaux; Rhumatologie
Saintes, 17100, France
Hopital Hautepierre; Rhumatologie
Strasbourg, 67098, France
Hopitaux du Leman site Thonon; Rhumatologie
Thonon-les-Bains, 74203, France
Cabinet de Rhumatologie
Toulouse, 31000, France
Hopital Purpan; Rhumatologie
Toulouse, 31059, France
Cabinet Medical
Tours, 37000, France
Cabinet Medical
Valenciennes, 59300, France
Hopitaux De Brabois; Rhumatologie
Vandœuvre-lès-Nancy, 54511, France
Hopital; Pole geriatrique
Villeneuve-sur-Lot, 47305, France
Related Publications (1)
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.
PMID: 33216287DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2015
First Posted
November 18, 2015
Study Start
December 31, 2015
Primary Completion
July 26, 2018
Study Completion
July 26, 2018
Last Updated
February 11, 2020
Record last verified: 2020-02