Clinical trial NCT02809833: Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine
Official title: Tocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical Routine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-06-22
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from routine clinical practice in Germany who are receiving tocilizumab for RA according to SmPC are eligible.

Brief summary: This prospective, multicenter, non-interventional study will enroll participants from routine clinical practice in Germany who are receiving tocilizumab for RA. The objective of the study is systematic collection of data on use of tocilizumab in daily routine with special emphasis on treatment decision by the prescriber, compliance with Summary of Product Characteristics (SmPC), and documentation of relevant activity scores and adverse drug reactions (ADRs). The maximum observation period will be 12 months per participant.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe RA
* Tocilizumab indicated in accordance with SmPC and chosen by the treating physician in advance of the study

Exclusion Criteria:

* None specified

Primary outcomes:
measure: Percentage of Participants With Categorized Laboratory Data Available at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Categorized Laboratory Data Available at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Categorized Laboratory Data Available at Week 52
timeFrame: Week 52
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4
timeFrame: Week 4
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8
timeFrame: Week 8
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12
timeFrame: Week 12
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16
timeFrame: Week 16
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20
timeFrame: Week 20
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24
timeFrame: Week 24
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28
timeFrame: Week 28
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32
timeFrame: Week 32
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36
timeFrame: Week 36
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40
timeFrame: Week 40
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44
timeFrame: Week 44
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48
timeFrame: Week 48
measure: Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Tocilizumab Dose Adjustments by Reason
timeFrame: Baseline to end of treatment (up to 12 months)
measure: 28-Joint Disease Activity Score (DAS28) at Baseline
timeFrame: Baseline
measure: Change in DAS28 From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in DAS28 From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Change in DAS28 From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in DAS28 From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Change in DAS28 From Baseline to Week 20
timeFrame: Baseline to Week 20
measure: Change in DAS28 From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in DAS28 From Baseline to Week 28
timeFrame: Baseline to Week 28
measure: Change in DAS28 From Baseline to Week 32
timeFrame: Baseline to Week 32
measure: Change in DAS28 From Baseline to Week 36
timeFrame: Baseline to Week 36
measure: Change in DAS28 From Baseline to Week 40
timeFrame: Baseline to Week 40
measure: Change in DAS28 From Baseline to Week 44
timeFrame: Baseline to Week 44
measure: Change in DAS28 From Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in DAS28 From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: TJC at Baseline
timeFrame: Baseline
measure: Change in TJC From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in TJC From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in TJC From Baseline to Week 36
timeFrame: Baseline to Week 36
measure: Change in TJC From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: SJC at Baseline
timeFrame: Baseline
measure: Change in SJC From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in SJC From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in SJC From Baseline to Week 36
timeFrame: Baseline to Week 36
measure: Change in SJC From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: VAS Score of Participant-Assessed Disease Activity at Baseline
timeFrame: Baseline
measure: Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 36
timeFrame: Baseline to Week 36
measure: Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: VAS Score of Physician-Assessed Disease Activity at Baseline
timeFrame: Baseline
measure: Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 36
timeFrame: Baseline to Week 36
measure: Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4
timeFrame: Baseline to Week 4
measure: Percentage of Participants With EULAR Response at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Participants With EULAR Response at Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants With EULAR Response at Week 36
timeFrame: Baseline to Week 36
measure: Percentage of Participants With EULAR Response at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants With Low Disease Activity Score (LDAS) According to DAS28 at Baseline
timeFrame: Baseline
measure: Percentage of Participants With LDAS According to DAS28 at Week 12
timeFrame: Week 12
measure: Percentage of Participants With LDAS According to DAS28 at Week 24
timeFrame: Week 24
measure: Percentage of Participants With LDAS According to DAS28 at Week 36
timeFrame: Week 36
measure: Percentage of Participants With LDAS According to DAS28 at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Remission According to DAS28 at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Remission According to DAS28 at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Remission According to DAS28 at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Remission According to DAS28 at Week 36
timeFrame: Week 36
measure: Percentage of Participants With Remission According to DAS28 at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Minimum Clinically Important Improvement (MCII) According to DAS28 at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Participants With MCII According to DAS28 at Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants With MCII According to DAS28 at Week 36
timeFrame: Baseline to Week 36
measure: Percentage of Participants With MCII According to DAS28 at Week 52
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Percentage of Participants With AEs Considered Causally Related to Tocilizumab
timeFrame: Baseline to end of treatment (up to 12 months)
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: