A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2022
• Main ID: NCT03457792
• Date of registration: 13/02/2018
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis ASCEND
• Scientific title: Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice
• Date of first enrolment: April 17, 2018
• Target sample size: 158
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03457792
• Study type: Observational

Countries of recruitment

Germany

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Primary Outcome(s)

Number of patients continuing with abatacept treatment [Time Frame: Up to 12 months]

Secondary Outcome(s)

Number of patients who achieve the first low disease activity score (LDAS), DAS28 = 3.2 [Time Frame: Up to 12 months]

Existence or the absence of radiographic erosions as determined by the investigator by imaging technique [Time Frame: At baseline]

Number of Adverse Events (AE) [Time Frame: Up to 12 months]

Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (= 1.2) [Time Frame: Up to 12 months]

Reason for abatacept treatment initiation as determined by the investigator [Time Frame: At baseline]

Simplified Disease Activity Score (based on 28 joints) (DAS28) [Time Frame: Up to 12 months]

Clinical disease activity index (CDAI) [Time Frame: Up to 12 months]

Dosage of abatacept as determined by the investigator [Time Frame: Up to 12 months]

Patient global assessment (PGA) [Time Frame: Up to 12 months]

Rheumatoid factor (RF) [Time Frame: Up to 12 months]

Number of patients who achieve the first remission state, DAS28 < 2.6 [Time Frame: Up to 12 months]

Number of Serious Adverse Events (SAE) [Time Frame: Up to 12 months]

Frequency of administration of abatacept [Time Frame: Up to 12 months]

Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Up to 12 months]

Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency) [Time Frame: Up to 12 months]

Anti-citrullinated protein antibody (ACPA) titer [Time Frame: At baseline]

Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria [Time Frame: Up to 12 months]

Simple disease activity index (SDAI) [Time Frame: Up to 12 months]

Concomitant treatment given with abatacept as determined by the investigator [Time Frame: Up to 12 months]

Disease history of participants as determined by the investigator [Time Frame: At baseline]

Evaluator global assessment (EGA) [Time Frame: Up to 12 months]

Existence or the absence of radiographic erosions as determined by the investigator by imaging technique [Time Frame: Up to 12 months]

Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD) [Time Frame: Up to 12 months]

Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia) [Time Frame: Up to 12 months]

Socio-demographics of participants as determined by the investigator [Time Frame: At baseline]

Secondary ID(s)

IM101-679

Source(s) of Monetary Support

Please refer to primary and secondary sponsors