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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01683604




Registration number
NCT01683604
Ethics application status
Date submitted
5/09/2012
Date registered
12/09/2012
Date last updated
21/07/2016

Titles & IDs
Public title
Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia
Scientific title
A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACT-UP)
Secondary ID [1] 0 0
ML28144
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Rheumatoid Arthritis (RA) Participants (All Groups) - Participants with severe RA were prescribed with tocilizumab in accordance with routine clinic practice, and were observed for 6 months.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
Timepoint [1] 0 0
Month 6
Primary outcome [2] 0 0
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Patient Global Assessment of Disease Activity Using VAS at Baseline
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Physician Global Assessment of Disease Activity Using VAS at Baseline
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline
Timepoint [5] 0 0
Baseline
Primary outcome [6] 0 0
Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
Timepoint [6] 0 0
Baseline
Primary outcome [7] 0 0
Erythrocyte Sedimentation Rate (ESR) at Baseline
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
C-Reactive Protein (CRP) at Baseline
Timepoint [8] 0 0
Baseline
Secondary outcome [1] 0 0
Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Median Dose at Month 6
Timepoint [2] 0 0
Month 6
Secondary outcome [3] 0 0
Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change
Timepoint [3] 0 0
Baseline up to Month 6
Secondary outcome [4] 0 0
Mean Dosing Interval at Month 6
Timepoint [4] 0 0
Month 6
Secondary outcome [5] 0 0
Percentage of Participants With Reasons Who Discontinued Tocilizumab
Timepoint [5] 0 0
Baseline up to Month 6
Secondary outcome [6] 0 0
Time to Restoration of Initial Dosing Regimen
Timepoint [6] 0 0
Baseline up to Month 6
Secondary outcome [7] 0 0
Percentage of Participants by Reason for Choice of Monotherapy at Baseline
Timepoint [7] 0 0
Baseline up to Month 6
Secondary outcome [8] 0 0
Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6
Timepoint [8] 0 0
Baseline, Month 6
Secondary outcome [9] 0 0
Duration of Tocilizumab Treatment
Timepoint [9] 0 0
Baseline up to Month 6
Secondary outcome [10] 0 0
Percentage of Participants by Duration of Morning Stiffness
Timepoint [10] 0 0
Baseline, Month 3, Month 6
Secondary outcome [11] 0 0
Percentage of Participants With and Without Morning Stiffness
Timepoint [11] 0 0
Baseline, Month 3, Month 6
Secondary outcome [12] 0 0
Percentage of Participants Adhering to Local Label for Adverse Events
Timepoint [12] 0 0
Baseline up to Month 6
Secondary outcome [13] 0 0
Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit
Timepoint [13] 0 0
Baseline, Month 3, Month 6
Secondary outcome [14] 0 0
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Timepoint [14] 0 0
Month 3 and Month 6
Secondary outcome [15] 0 0
Clinical Disease Activity Index (CDAI) Score by Visit
Timepoint [15] 0 0
Baseline, Month 3, Month 6
Secondary outcome [16] 0 0
Change From Baseline in TJC and SJC at Month 3 and Month 6
Timepoint [16] 0 0
Baseline, Month 3, Month 6
Secondary outcome [17] 0 0
Simplified Disease Activity Index (SDAI) Score by Visit
Timepoint [17] 0 0
Baseline, Month 3, Month 6
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Month 3 and Month 6
Secondary outcome [19] 0 0
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
Timepoint [19] 0 0
Baseline, Month 3, Month 6
Secondary outcome [20] 0 0
Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6
Timepoint [20] 0 0
Baseline, Month 3, Month 6
Secondary outcome [21] 0 0
Change From Baseline in HAQ-DI Score at Months 3 and 6
Timepoint [21] 0 0
Baseline, Month 3, Month 6
Secondary outcome [22] 0 0
Change From Baseline in VAS-Fatigue at Months 3 and 6
Timepoint [22] 0 0
Baseline, Month 3, Month 6
Secondary outcome [23] 0 0
Change From Baseline in Patient's Assessment of Pain at Months 3 and 6
Timepoint [23] 0 0
Baseline, Month 3, Month 6
Secondary outcome [24] 0 0
Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6
Timepoint [24] 0 0
Baseline, Month 3, Month 6

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
- Campsie
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- New Lambton
Recruitment hospital [4] 0 0
- Woodville
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Morwell
Recruitment hospital [7] 0 0
- Shenton Park
Recruitment postcode(s) [1] 0 0
2194 - Campsie
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3842 - Morwell
Recruitment postcode(s) [7] 0 0
6008 - Shenton Park

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01683604
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01683604