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Completed

NCT Number: NCT03457792

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Freiburg im Breisgau, 79095, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients continuing with abatacept treatment

    Time frame: Up to 12 months

Secondary outcomes

  1. Anti-citrullinated protein antibody (ACPA) titer

    Time frame: At baseline

  2. Concomitant treatment given with abatacept as determined by the investigator

    Time frame: Up to 12 months

  3. Dosage of abatacept as determined by the investigator

    Time frame: Up to 12 months

  4. Frequency of administration of abatacept

    Time frame: Up to 12 months

  5. Reason for abatacept treatment initiation as determined by the investigator

    Time frame: At baseline

  6. Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)

    Time frame: Up to 12 months

  7. Socio-demographics of participants as determined by the investigator

    Time frame: At baseline

  8. Disease history of participants as determined by the investigator

    Time frame: At baseline

  9. Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)

    Time frame: Up to 12 months

  10. Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)

    Time frame: Up to 12 months

  11. Simplified Disease Activity Score (based on 28 joints) (DAS28)

    Time frame: Up to 12 months

    DAS28: Swollen joint count [SJC], tender joint count [TJC], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]

  12. Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria

    Time frame: Up to 12 months

  13. Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2)

    Time frame: Up to 12 months

  14. Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2

    Time frame: Up to 12 months

  15. Number of patients who achieve the first remission state, DAS28 < 2.6

    Time frame: Up to 12 months

  16. Number of Adverse Events (AE)

    Time frame: Up to 12 months

  17. Number of Serious Adverse Events (SAE)

    Time frame: Up to 12 months

  18. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: Up to 12 months

  19. Existence or the absence of radiographic erosions as determined by the investigator by imaging technique

    Time frame: At baseline

  20. Existence or the absence of radiographic erosions as determined by the investigator by imaging technique

    Time frame: Up to 12 months

  21. Rheumatoid factor (RF)

    Time frame: Up to 12 months

  22. Patient global assessment (PGA)

    Time frame: Up to 12 months

  23. Evaluator global assessment (EGA)

    Time frame: Up to 12 months

  24. Clinical disease activity index (CDAI)

    Time frame: Up to 12 months

  25. Simple disease activity index (SDAI)

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: ASCEND

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2018
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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