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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01683604