An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02552940
• Date of registration: 16/09/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice
• Scientific title: A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE
• Date of first enrolment: October 31, 2015
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02552940
• Study type: Observational

Countries of recruitment

Belgium, Luxembourg

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior
to the enrolment visit can be included

- Participants in whom the treating physician has made the decision to commence TCZ SC
in accordance with the label and reimbursement criteria

Exclusion Criteria:

- Participants who have received TCZ >8 weeks prior to the enrolment visit

- Participants who have previously received TCZ SC

- Participants who have received treatment with any investigational agent within 4 weeks
before starting treatment with TCZ SC



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tocilizumab

Primary Outcome(s)

Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl) [Time Frame: Up to Week 24]

Secondary Outcome(s)

Morisky Medication-Taking Adherence Scale (MMAS) [Time Frame: Up to Week 24]

Percentage of participants having SJC <=1 [Time Frame: Up to Week 24]

Patient Global Assessment of disease activity visual analogue scale (VAS) score [Time Frame: Up to Week 24]

Percentage of participants to achieve a major and minor improvement in CDAl (more than or equal to [>=]13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively) [Time Frame: Up to Week 24]

EQ-5D-5L Health Questionnaire (EuroQoL) [Time Frame: Up to Week 24]

Percentage of participants using TCZ in monotherapy [Time Frame: At baseline]

Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR [Time Frame: Up to Week 24]

Percentage of participants having CRP <=1mg/dl [Time Frame: Up to Week 24]

Percentage of participants having TJC <=1 [Time Frame: Up to Week 24]

Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3) [Time Frame: Up to Week 24]

Change from baseline in total tender joint count (TJC) [Time Frame: Up to Week 24]

Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Up to Week 24]

Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's) [Time Frame: At baseline]

Percentage of participants presenting a high inflammation (DAS28-ESR >5.1) [Time Frame: At baseline]

Percentage of participants to achieve low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0) [Time Frame: Up to Week 24]

Physician Global Assessment of disease activity VAS score [Time Frame: Up to Week 24]

Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3) [Time Frame: Up to Week 24]

Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0) [Time Frame: Up to week 24]

Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units) [Time Frame: Up to Week 24]

Change from baseline in total swollen joint count (SJC) [Time Frame: Up to Week 24]

Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units) [Time Frame: Up to Week 24]

Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively) [Time Frame: Up to Week 24]

Secondary ID(s)

ML29691

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

nv Roche sa