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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03457792
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-08
• Study Start: 2018-04-17
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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)

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Exclusion Criteria

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

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients continuing with abatacept treatment	Up to 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution; 🇩🇪 Freiburg im Breisgau, Germany