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Completed

NCT Number: NCT03419143

Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.

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Key information

Conditions

Psoriatic Arthritis (PsA) Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Nuremberg, 90429, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants 18 years or older
  • Participants who signed an informed consent
  • Participants diagnosed with PsA as per the criteria of the Classification of Psoriatic Arthritis (CASPAR) Study Group18
  • Participants naïve of abatacept and who at their physician's discretion initiate abatacept
  • Participants meeting criteria for abatacept treatment for PsA as specified in the German label

Exclusion criteria

  • Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)

Treatment and study plan

Primary outcomes

  1. Disease Activity index for PSoriatic Arthritis (DAPSA)

    Time frame: 12 months

Secondary outcomes

  1. Participant retention rate

    Time frame: 12 Months

  2. Proportion of concomitant treatment given

    Time frame: 12 Months

  3. Initial dosage of Abatacept given

    Time frame: At Treatment Initiation

  4. Frequency of Abatacept administration

    Time frame: 12 months

  5. Descriptive Analysis: Reasons for Abatacept initiation

    Time frame: up to 2 years prior to treatment

  6. Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD)

    Time frame: up to 2 years prior to treatment

  7. Descriptive Analysis: Socio-Demographics at Treatment Initiation

    Time frame: At Treatment Initiation

  8. Descriptive Analysis: Disease history at Treatment initiation

    Time frame: Prior to treatment

  9. Incidence of Risk factors and Comorbidities

    Time frame: At Treatment Initiation

  10. Descriptive Analysis: Baseline Characteristics

    Time frame: up to 2 years prior to treatment

  11. Descriptive Analysis: Change in participant characteristics and symptoms

    Time frame: 12 months

  12. Proportion of Rheumatologist: Geography

    Time frame: up to 2 months prior to treatment to 12 months post treatment

  13. Proportion of Rheumatologist: Type of Institution

    Time frame: up to 2 months prior to treatment to 12 months post treatment

  14. Proportion and type of treatment after abatacept discontinuation

    Time frame: 12 months

  15. Proportion of reasons for abatacept discontinuation and initiation of new therapy

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)

Acronym: ALTEA

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2018
Registry last updated
May 31, 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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