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Completed

NCT Number: NCT02608112

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Nord; Rhumatologie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

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

Tocilizumab

Drug

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 18, 2015
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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