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

Rheumatoid Arthritis Clinical Trial

— ASCEND  

Official title:

Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457792
• Other study ID #: IM101-679
• Status: Completed
• Start date: April 17, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Germany	Local Institution	Freiburg im Breisgau

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients continuing with abatacept treatment		Up to 12 months
Secondary	Anti-citrullinated protein antibody (ACPA) titer		At baseline
Secondary	Concomitant treatment given with abatacept as determined by the investigator		Up to 12 months
Secondary	Dosage of abatacept as determined by the investigator		Up to 12 months
Secondary	Frequency of administration of abatacept		Up to 12 months
Secondary	Reason for abatacept treatment initiation as determined by the investigator		At baseline
Secondary	Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)		Up to 12 months
Secondary	Socio-demographics of participants as determined by the investigator		At baseline
Secondary	Disease history of participants as determined by the investigator		At baseline
Secondary	Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)		Up to 12 months
Secondary	Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)		Up to 12 months
Secondary	Simplified Disease Activity Score (based on 28 joints) (DAS28)	DAS28: Swollen joint count [SJC], tender joint count [TJC], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]	Up to 12 months
Secondary	Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria		Up to 12 months
Secondary	Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (= 1.2)		Up to 12 months
Secondary	Number of patients who achieve the first low disease activity score (LDAS), DAS28 = 3.2		Up to 12 months
Secondary	Number of patients who achieve the first remission state, DAS28 < 2.6		Up to 12 months
Secondary	Number of Adverse Events (AE)		Up to 12 months
Secondary	Number of Serious Adverse Events (SAE)		Up to 12 months
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI)		Up to 12 months
Secondary	Existence or the absence of radiographic erosions as determined by the investigator by imaging technique		At baseline
Secondary	Existence or the absence of radiographic erosions as determined by the investigator by imaging technique		Up to 12 months
Secondary	Rheumatoid factor (RF)		Up to 12 months
Secondary	Patient global assessment (PGA)		Up to 12 months
Secondary	Evaluator global assessment (EGA)		Up to 12 months
Secondary	Clinical disease activity index (CDAI)		Up to 12 months
Secondary	Simple disease activity index (SDAI)		Up to 12 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form