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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03457792
Date of registration: 13/02/2018
Prospective Registration: No
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: December 19, 2017
Target sample size: 400
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03457792
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Germany
Contacts
Name:     Site 0001
Address: 
Telephone:
Email:
Affiliation: 
Name:     Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address: 
Telephone: please email:
Email: Clinical.Trials@bms.com
Affiliation: 
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
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
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
Number of patients continuing with abatacept treatment [Time Frame: Up to 12 months]
Secondary Outcome(s)
Anti-citrullinated protein antibody (ACPA) titer [Time Frame: At baseline]
Clinical disease activity index (CDAI) [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]
Dosage of abatacept as determined by the investigator [Time Frame: Up to 12 months]
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: At baseline]
Existence or the absence of radiographic erosions as determined by the investigator by imaging technique [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 Adverse Events (AE) [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 who achieve the first clinically significant Disease Activity Score (DAS)-change (= 1.2) [Time Frame: Up to 12 months]
Number of patients who achieve the first low disease activity score (LDAS), DAS28 = 3.2 [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 patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria [Time Frame: Up to 12 months]
Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia) [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]
Number of Serious Adverse Events (SAE) [Time Frame: Up to 12 months]
Patient global assessment (PGA) [Time Frame: Up to 12 months]
Reason for abatacept treatment initiation as determined by the investigator [Time Frame: At baseline]
Rheumatoid factor (RF) [Time Frame: Up to 12 months]
Simple disease activity index (SDAI) [Time Frame: Up to 12 months]
Simplified Disease Activity Score (based on 28 joints) (DAS28) [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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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