Clinical trial NCT03663829: 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
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 2052
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of rheumatoid arthritis (RA) who have received a TNFi or abatacept and registered in the OPAL registry

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


Eligibility criteria: 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

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

Primary outcomes:
measure: ACPA (Anti-cyclic citrullinated peptide) status
timeFrame: Pre-Index
Secondary outcomes:
measure: Number of participants with positive ACPA
timeFrame: Index
measure: Number of participants with negative ACPA
timeFrame: Index
measure: CDAI (clinical disease activity index) score
timeFrame: Index plus or minus 1 month
measure: CDAI (clinical disease activity index) score
timeFrame: 12 months plus or minus 3 months
measure: DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score
timeFrame: Index plus or minus 1 month
measure: DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score
timeFrame: 12 months plus or minus 3 months
measure: Number of participants with treatment persistence
timeFrame: Approximately 11 years and 5 months
measure: Number of participants with treatment discontinuation
timeFrame: Approximately 11 years and 5 months
measure: Number of participants identified as taking abatacept
timeFrame: Index
measure: Number of participants identified as taking TNFi (tumor necrosis factor inhibitor)
timeFrame: Index
measure: Number of participants that achieved remission
timeFrame: 12 months plus or minus 3 months
Other outcomes:
Locations:
city: Canberra City
country: Australia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: