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

Browse trials for

• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 291 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study population

Groups and cohorts

• 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.

  Drug: Methotrexate · Drug: Tocilizumab

Interventions

• DrugMethotrexate

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

• DrugTocilizumab

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

Primary outcomes

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

   Time frame: Up to 12 Months

Secondary outcomes

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

   Time frame: Months 3, 6, 12, and 18

2. Simple Disease Activity Index (SDAI)

   Time frame: Months 3, 6, 12, and 18

3. Clinical Disease Activity Index (CDAI)

   Time frame: Months 3, 6, 12, and 18

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

   Time frame: Months 3, 6, 12, and 18

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

   Time frame: Up to 6 Months

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

   Time frame: 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

   Time frame: Up to 18 Months

8. Dose of Concomitant Steroids After Introduction of TCZ SC

   Time frame: 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

   Time frame: Months 6, 12, and 18

10. Percentage of Participants with Definitive Discontinuation of Treatment

    Time frame: Up to 18 Months

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

    Time frame: Up to 18 Months

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

    Time frame: Up to 18 Months

13. Tender Joints Count

    Time frame: Months 3, 6, 12, and 18

14. Swollen Joints Count

    Time frame: Months 3, 6, 12, and 18

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

    Time frame: Months 3, 6, 12, and 18

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 ↗