Clinical trial NCT01683604: Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia
Official title: A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACT-UP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RA participants treated with tocilizumab

Brief summary: This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start of treatment.


Eligibility criteria: Inclusion Criteria:

* Severe RA.
* Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
* Participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit.

Exclusion Criteria:

* Tocilizumab treatment more than 8 weeks prior to the enrolment visit.
* Previous tocilizumab treatment in a clinical trial or for compassionate use.
* Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab.
* History of autoimmune disease or any joint inflammatory disease other than RA.

Primary outcomes:
measure: Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
timeFrame: Month 6
measure: Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
timeFrame: Baseline
measure: Patient Global Assessment of Disease Activity Using VAS at Baseline
timeFrame: Baseline
measure: Physician Global Assessment of Disease Activity Using VAS at Baseline
timeFrame: Baseline
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline
timeFrame: Baseline
measure: Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
timeFrame: Baseline
measure: Erythrocyte Sedimentation Rate (ESR) at Baseline
timeFrame: Baseline
measure: C-Reactive Protein (CRP) at Baseline
timeFrame: Baseline
Secondary outcomes:
measure: Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs
timeFrame: Baseline
measure: Median Dose at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change
timeFrame: Baseline up to Month 6
measure: Mean Dosing Interval at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Reasons Who Discontinued Tocilizumab
timeFrame: Baseline up to Month 6
measure: Time to Restoration of Initial Dosing Regimen
timeFrame: Baseline up to Month 6
measure: Percentage of Participants by Reason for Choice of Monotherapy at Baseline
timeFrame: Baseline up to Month 6
measure: Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6
timeFrame: Baseline, Month 6
measure: Duration of Tocilizumab Treatment
timeFrame: Baseline up to Month 6
measure: Percentage of Participants by Duration of Morning Stiffness
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants With and Without Morning Stiffness
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants Adhering to Local Label for Adverse Events
timeFrame: Baseline up to Month 6
measure: Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
timeFrame: Month 3 and Month 6
measure: Clinical Disease Activity Index (CDAI) Score by Visit
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in TJC and SJC at Month 3 and Month 6
timeFrame: Baseline, Month 3, Month 6
measure: Simplified Disease Activity Index (SDAI) Score by Visit
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment
timeFrame: Month 3 and Month 6
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in HAQ-DI Score at Months 3 and 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in VAS-Fatigue at Months 3 and 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Patient's Assessment of Pain at Months 3 and 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6
timeFrame: Baseline, Month 3, Month 6
Other outcomes:
Locations:
city: Campsie
country: Australia
state: New South Wales
city: Coffs Harbour
country: Australia
state: New South Wales
city: New Lambton
country: Australia
state: New South Wales
city: Woodville
country: Australia
state: South Australia
city: Heidelberg
country: Australia
state: Victoria
city: Morwell
country: Australia
state: Victoria
city: Shenton Park
country: Australia
state: Western Australia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: