Clinical trial NCT03457792: A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis
Official title: Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-03-08
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participant population targeted in this study consists of participants with early-stage RA (i.e. diagnosis of RA not longer than 24 months) that initiate treatment with Abatacept.

Brief summary: This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.


Eligibility criteria: Inclusion Criteria:

* Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA
* Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)

Exclusion Criteria:

* Participants who are currently included in any interventional clinical trial in RA

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of patients continuing with abatacept treatment
timeFrame: Up to 12 months
Secondary outcomes:
measure: Anti-citrullinated protein antibody (ACPA) titer
timeFrame: At baseline
measure: Concomitant treatment given with abatacept as determined by the investigator
timeFrame: Up to 12 months
measure: Dosage of abatacept as determined by the investigator
timeFrame: Up to 12 months
measure: Frequency of administration of abatacept
timeFrame: Up to 12 months
measure: Reason for abatacept treatment initiation as determined by the investigator
timeFrame: At baseline
measure: Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)
timeFrame: Up to 12 months
measure: Socio-demographics of participants as determined by the investigator
timeFrame: At baseline
measure: Disease history of participants as determined by the investigator
timeFrame: At baseline
measure: Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)
timeFrame: Up to 12 months
measure: Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)
timeFrame: Up to 12 months
measure: Simplified Disease Activity Score (based on 28 joints) (DAS28)
timeFrame: Up to 12 months
measure: Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria
timeFrame: Up to 12 months
measure: Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2)
timeFrame: Up to 12 months
measure: Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2
timeFrame: Up to 12 months
measure: Number of patients who achieve the first remission state, DAS28 < 2.6
timeFrame: Up to 12 months
measure: Number of Adverse Events (AE)
timeFrame: Up to 12 months
measure: Number of Serious Adverse Events (SAE)
timeFrame: Up to 12 months
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Up to 12 months
measure: Existence or the absence of radiographic erosions as determined by the investigator by imaging technique
timeFrame: At baseline
measure: Existence or the absence of radiographic erosions as determined by the investigator by imaging technique
timeFrame: Up to 12 months
measure: Rheumatoid factor (RF)
timeFrame: Up to 12 months
measure: Patient global assessment (PGA)
timeFrame: Up to 12 months
measure: Evaluator global assessment (EGA)
timeFrame: Up to 12 months
measure: Clinical disease activity index (CDAI)
timeFrame: Up to 12 months
measure: Simple disease activity index (SDAI)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Freiburg im Breisgau
country: Germany
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: