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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03663829




Registration number
NCT03663829
Ethics application status
Date submitted
6/09/2018
Date registered
10/09/2018
Date last updated
9/03/2022

Titles & IDs
Public title
Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Participants With Rheumatoid Arthritis (RA) Who Are Treated With Abatacept or Tumor Necrosis Factor Inhibitors in Australia
Scientific title
Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Patients With Rheumatoid Arthritis Who Are Treated With Abatacept or Tumour Necrosis Factor Inhibitors. An Analysis From the Optimising Patient Outcome in Australian Rheumatology (OPAL) Registry.
Secondary ID [1] 0 0
IM101-728
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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Non-Interventional
Other interventions - Non-Interventional

Participants RA who have received a TNFi -

Participants with RA who have received abatacept -


Other interventions: Non-Interventional
Non-Interventional

Other interventions: Non-Interventional
Non-Interventional
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ACPA (Anti-cyclic citrullinated peptide) status
Timepoint [1] 0 0
Pre-Index
Secondary outcome [1] 0 0
Number of participants with positive ACPA
Timepoint [1] 0 0
Index
Secondary outcome [2] 0 0
Number of participants with negative ACPA
Timepoint [2] 0 0
Index
Secondary outcome [3] 0 0
CDAI (clinical disease activity index) score
Timepoint [3] 0 0
Index plus or minus 1 month
Secondary outcome [4] 0 0
CDAI (clinical disease activity index) score
Timepoint [4] 0 0
12 months plus or minus 3 months
Secondary outcome [5] 0 0
DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score
Timepoint [5] 0 0
Index plus or minus 1 month
Secondary outcome [6] 0 0
DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score
Timepoint [6] 0 0
12 months plus or minus 3 months
Secondary outcome [7] 0 0
Number of participants with treatment persistence
Timepoint [7] 0 0
Approximately 11 years and 5 months
Secondary outcome [8] 0 0
Number of participants with treatment discontinuation
Timepoint [8] 0 0
Approximately 11 years and 5 months
Secondary outcome [9] 0 0
Number of participants identified as taking abatacept
Timepoint [9] 0 0
Index
Secondary outcome [10] 0 0
Number of participants identified as taking TNFi (tumor necrosis factor inhibitor)
Timepoint [10] 0 0
Index
Secondary outcome [11] 0 0
Number of participants that achieved remission
Timepoint [11] 0 0
12 months plus or minus 3 months

Eligibility
Key inclusion criteria
- Diagnosed with rheumatoid arthritis

- Have a baseline ACPA recorded

- Received either abatacept or a TNFi (adalimumab, certolizumab, etanercept or
golimumab) during the sample selection window 1 August 2006 to 30 June 2017
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have died

- Patients with concomitant inflammatory diseases (e.g. ankylosing spondylitis,
psoriatic arthritis, Crohn's disease, ulcerative colitis)

- Patients who have no visit data recorded (even if medication data is available)

Other protocol defined inclusion/exclusion criteria could apply

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/12/2019
Sample size
Target
Accrual to date
Final
2052
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Canberra City
Recruitment postcode(s) [1] 0 0
- Canberra City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
An observational study assessing the impact of anti-citrullinated antibody (ACPA) in
rheumatoid arthritis (RA) participants who have received abatacept or tumour necrosis factor
inhibitors (TNFi) from the Optimising Patient outcome in Australian rheumatoLogy (OPAL)
registry
Trial website
https://clinicaltrials.gov/ct2/show/NCT03663829
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/ct2/show/NCT03663829