NCT02598466 - Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa | Crick | Crick

Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa

N/ACompletedNCT02598466

Bristol-Myers Squibb69 enrolled

Overview

Research question: what are the patterns of patient-reported changes in physical function among adult patients using SC abatacept with moderate to severe RA since commencement of the compassionate use program (CUP).

Study Type

OBSERVATIONAL

Enrollment

69

Conditions

Rheumatoid Arthritis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The global clinical trials and associated long-term extension phases imposed inclusion and exclusion criteria. Only patients that completed the clinical trials and the long-term extension phase were eligible for inclusion in the CUP

Outcomes

Primary Outcomes

Patterns of change in patient assessments of physical function with scores of the Health Assessment Questionnaire (HAQ) among users of SC Abatacept for RA since the commencement of a CUP in South Africa's private sector

Time frame: Approximately 2 years

Secondary Outcomes

Demographic characteristics (age, gender, education and population group) of patients

Time frame: Approximately 2 years

Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients

Time frame: Approximately 2 years

Reasons for discontinuation based on the reasons mentioned in Questionnaire

Reasons for discontinuation: defined as common responses given for stopping treatment and include death, adverse event, lack of efficacy, lost to follow-up, withdrawal of consent, or other reasons

Time frame: Approximately 2 years

Reasons for skipping treatment based on the reasons mentioned in Questionnaire

Reasons for skipping treatment: defined as explanations given for inability to adhere to the recommended treatment regime and include fear of side effects, lack of access (too far) to medicine, inconvenient to use, too busy or forgetting, or other reasons

Time frame: Approximately 2 years

Association of demographic and clinical characteristics based on Standard Disability Index of the Health Assessment Questionnaire (HAQ-DI) scores

Time frame: Approximately 2 years

Changes in physical functioning against clinical trial and long-term extension phase data based incidence of adverse events

Adverse events: defined as any untoward medical event in a patient whether related or unrelated to SC abatacept and may include any sign (laboratory finding), symptom, or disease

Data from ClinicalTrials.gov

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