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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02608112
• Date of registration: 16/11/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year
• Scientific 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
• Date of first enrolment: December 31, 2015
• Target sample size: 291
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02608112
• Study type: Observational

Countries of recruitment

France

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tocilizumab

Drug: Methotrexate

Primary Outcome(s)

Percentage of Participants Who Were on TCZ SC for a Period of 12 Months [Time Frame: Up to 12 Months]

Secondary Outcome(s)

Simple Disease Activity Index (SDAI) [Time Frame: Months 3, 6, 12, and 18]

Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) [Time Frame: Months 3, 6, 12, and 18]

Dose of Concomitant Steroids After Introduction of TCZ SC [Time Frame: Months 6, 12, and 18]

Tender Joints Count [Time Frame: Months 3, 6, 12, and 18]

Percentage of Participants Who Were on TCZ SC for a Period of 18 Months [Time Frame: Up to 18 Months]

Percentage of Participants Who Were on TCZ SC for a Period of 6 Months [Time Frame: Up to 6 Months]

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]

Clinical Disease Activity Index (CDAI) [Time Frame: Months 3, 6, 12, and 18]

Percentage of Participants with Definitive Discontinuation of Treatment [Time Frame: Up to 18 Months]

Percentage of Participants Taking Sick Leaves or Getting Hospitalized Due to RA [Time Frame: Up to 18 Months]

Percentage of Participants Performing All Visits at Hospital/Office Based Rheumatologist [Time Frame: Up to 18 Months]

Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response [Time Frame: Months 3, 6, 12, and 18]

Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP) [Time Frame: Months 3, 6, 12, and 18]

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]

Swollen Joints Count [Time Frame: Months 3, 6, 12, and 18]

Secondary ID(s)

ML29256

Source(s) of Monetary Support

Please refer to primary and secondary sponsors