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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Germany
  • Freiburg im Breisgau, Germany, 79095
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Abatacept for Rheumatoid Arthritis (RA); Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients continuing with abatacept treatment	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-citrullinated protein antibody (ACPA) titer		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
Frequency of administration of abatacept		Up to 12 months
Reason for abatacept treatment initiation as determined by the investigator		At baseline
Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)		Up to 12 months
Socio-demographics of participants as determined by the investigator		At baseline
Disease history of participants as determined by the investigator		At baseline
Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)		Up to 12 months
Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)		Up to 12 months
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
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 clinically significant Disease Activity Score (DAS)-change (≥ 1.2)		Up to 12 months
Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2		Up to 12 months
Number of patients who achieve the first remission state, DAS28 < 2.6		Up to 12 months
Number of Adverse Events (AE)		Up to 12 months
Number of Serious Adverse Events (SAE)		Up to 12 months
Health Assessment Questionnaire Disability Index (HAQ-DI)		Up to 12 months
Existence or the absence of radiographic erosions as determined by the investigator by imaging technique		At baseline
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
Patient global assessment (PGA)		Up to 12 months
Evaluator global assessment (EGA)		Up to 12 months
Clinical disease activity index (CDAI)		Up to 12 months
Simple disease activity index (SDAI)		Up to 12 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IM101-679

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No