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Rheumatoid ArthritisNCT02608112

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

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 77 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Methotrexate and Tocilizumab
Type of treatment
Injection or infusion
How many people
291 participants
Where
77 sitesFrance
Study dates
31 Dec 2015to 26 Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

France77 sites

  • Hopital Nord; Rhumatologie

    Amiens, 80054

  • Ch D Ardeche Meridionale; Medecine A2

    Aubenas, 07205

  • Ch De Belfort; Rhumatologie

    Belfort, 90016

  • Institut Calot Helio Marin; Rhumatologie

    Berck, 62608

  • Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Pellegrin; Rhumatologie

    Bordeaux, 33076

  • Hopital La Cavale Blanche; Rhumatologie

    Brest, 29609

  • Hopital Cote De Nacre; Rhumatologie

    Caen, 14033

  • CH Jean Rougier; Rhumato Reed Fonctionnelle

    Cahors, 46005

  • Infirmerie Protestante; Medecine interne Cancerologie

    Caluire-et-Cuire, 69300

  • Hopital Pierre Nouveau;Medecine C Unite Rhumatologie

    Cannes, 06401

  • Cabinet medical,Rhumatologie

    Castelnaudary, 11400

  • Hopital Trousseau; Rhumatologie

    Chambray-lès-Tours, 37171

  • HIA PERCY; Medecine Interne

    Clamart, 92141

  • Hopital Gabriel Montpied; Service de Rhumatologie

    Clermont-Ferrand, 63003

  • CH compiègne

    Compiègne, 60200

  • Centre Hospitalier Alpes

    Contamine-sur-Arve, 74130

  • Chu Sud Francilien; Rhumatologie

    Corbeil-essones, 91106

  • CH Sud Francilien; Rhumatologie

    Corbeil-Essonnes, 91106

  • Hopital Henri Mondor; Rhumatologie

    Créteil, 94010

  • CH de Dax

    Dax, 40107

  • Ch De Douai; Medecine Polyvalente

    Dechy, 59187

  • Ch Louis Pasteur; Rhumato Med Interne Neurologie

    Dole, 39108

  • Hopital Victor Jousselin; Rhumatologie 4EME Sud

    Druex, 28102

  • Hopital Sud; Rhumatologie

    Échirolles, 38434

  • Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

    Gap, 05000

  • Cabinet Medical.

    Haguenau, 67500

  • Cabinet Medical

    Haguenau, 67500

  • Cabinet medical; Rhumatologie

    Joué-lès-Tours, 37300

  • CH de Juvisy sur Orge; Consult. externes

    Juvisy-sur-Orge, 91265

  • Cabinet

    La Madeleine, 59110

  • Hopital La Source; Rhumatologie

    La Source, 45100

  • Ch De Laon; Medecine Interne

    Laon, 02001

  • Ch Louis Pasteur; Medecine B3

    Le Coudray, 28630

  • CH de Bicêtre; Rhumatologie

    Le Kremlin-Bicêtre, 94275

  • Hopital Emile Roux; Rhumatologie

    Le Puy-en-Velay, 43012

  • Hopital B Roger Salengro; Rhumatologie

    Lille, 59037

  • Cabinet medical.

    Lille, 59800

  • Hopital Dupuytren; Rhumatologie

    Limoges, 87042

  • Cabinet de Rhumatologie MSP de Beaublanc

    Limoges, 87100

  • Ctre De Rhumato Lyon Presqu ile

    Lyon, 69002

  • Hopital Edouard Herriot; Pavillon F Rhumatologie

    Lyon, 69437

  • Hopital Sainte Marguerite; Rhumatologie

    Marseille, 13274

  • Fondation Hopital Saint Joseph; Rhumatologie

    Marseille, 13285

  • CH Annecy Genevois; Rhumatologie

    Metz-Tessy, 74370

  • GHI Le Raincy Montfermeil

    Montfermeil, 93370

  • Cabinet medical; Cabinet medical

    Montpellier, 34000

  • Cabinet Medical

    Montpellier, 34070

  • Hopital Lapeyronie; Immunologie Rhumatologie

    Montpellier, 34295

  • Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen

    Montpellier, 34295

  • Ch Des Pays De Morlaix; Medecine I

    Morlaix, 29672

  • Cabinet Medical

    Nice, 06000

  • Hopital Pasteur; Rhumatologie

    Nice, 06002

  • Maison de Santé; MSP

    Nogent-le-Rotrou, 28400

  • Ch Pitie Salpetriere; Rhumatologie

    Paris, 75651

  • Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie

    Paris, 75960

  • Ch Lyon Sud; Rhumato Secteur Jules Courmont

    Pierre-Bénite, 69495

  • Cabinet

    Poitiers, 86000

  • Chu La Miletrie; Rhumatologie

    Poitiers, 86021

  • Hopital Sud Anne de Bretagne; Rhumatologie

    Rennes, 35203

  • Hôpital Victor Provo

    Roubaix, 59056

  • Centre Medico-Chirurgical de Touraine

    Saint-Cyr-sur-Loire, 37540

  • Cabinet Medical

    Saint-Lô, 50000

  • Hopital Instruction Armees Begin; Rhumatologie

    Saint-Mandé, 94163

  • Centre Hopsitalier Saint Nazaire; Medecine Polyvalente

    Saint-Nazaire, 44606

  • Hopital Nord; Rhumatologie

    Saint-Priest-en-Jarez, 42277

  • Centre Hospitalier Saint Quentin

    Saint-Quentin, 02321

  • CH de Saint Quentin

    Saint-Quentin, 2100

  • Centre medical des coteaux; Rhumatologie

    Saintes, 17100

  • Hopital Hautepierre; Rhumatologie

    Strasbourg, 67098

  • Hopitaux du Leman site Thonon; Rhumatologie

    Thonon-les-Bains, 74203

  • Cabinet de Rhumatologie

    Toulouse, 31000

  • Hopital Purpan; Rhumatologie

    Toulouse, 31059

  • Cabinet Medical

    Tours, 37000

  • Cabinet Medical

    Valenciennes, 59300

  • Hopitaux De Brabois; Rhumatologie

    Vandœuvre-lès-Nancy, 54511

  • Hopital; Pole geriatrique

    Villeneuve-sur-Lot, 47305

Other trials in France

About this study

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

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).

Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.

  • TocilizumabDrug

    Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.

Study groups in NCT02608112
Study groupRoleWhat they receive
Participants with Moderate to Severe RAParticipants 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.
Receives: Drug: Methotrexate; Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Were on TCZ SC for a Period of 12 Months

    Measured: Up to 12 Months

Secondary outcomes (15)

  1. Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP)

    Measured: Months 3, 6, 12, and 18

  2. Simple Disease Activity Index (SDAI)

    Measured: Months 3, 6, 12, and 18

  3. Clinical Disease Activity Index (CDAI)

    Measured: Months 3, 6, 12, and 18

  4. Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response

    Measured: Months 3, 6, 12, and 18

  5. Percentage of Participants Who Were on TCZ SC for a Period of 6 Months

    Measured: Up to 6 Months

  6. Percentage of Participants Who Were on TCZ SC for a Period of 18 Months

    Measured: Up to 18 Months

  7. 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

    Measured: Up to 18 Months

  8. Dose of Concomitant Steroids After Introduction of TCZ SC

    Measured: Months 6, 12, and 18

  9. Number of Participants with Adherence to TCZ SC Using the Compliance Questionnaire of Rheumatology 5 (CQR5) and Participants Diary Data

    Measured: Months 6, 12, and 18

  10. Percentage of Participants with Definitive Discontinuation of Treatment

    Measured: Up to 18 Months

  11. Percentage of Participants Performing All Visits at Hospital/Office Based Rheumatologist

    Measured: Up to 18 Months

  12. Percentage of Participants Taking Sick Leaves or Getting Hospitalized Due to RA

    Measured: Up to 18 Months

  13. Tender Joints Count

    Measured: Months 3, 6, 12, and 18

  14. Swollen Joints Count

    Measured: Months 3, 6, 12, and 18

  15. Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR)

    Measured: Months 3, 6, 12, and 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2015 (estimated)
  2. Study start31 Dec 2015
  3. Primary completion26 Jul 2018
  4. Study completion26 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
291 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02608112
Sponsor's protocol ID
ML29256
Status last verified
Feb 2020
First submitted
16 Nov 2015
Last updated
11 Feb 2020
Results posted
No

Publications

  • 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.

    PubMed 33216287

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 77 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Were on TCZ SC for a Period of 12 Months (time frame: Up to 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02608112, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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