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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Abatacept

• Registration Number: NCT02598466
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-05
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abatacept	Abatacept	-

Primary Outcome Measures

Name	Time	Method
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	Approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Association of demographic and clinical characteristics based on Standard Disability Index of the Health Assessment Questionnaire (HAQ-DI) scores	Approximately 2 years
Demographic characteristics (age, gender, education and population group) of patients	Approximately 2 years
Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients	Approximately 2 years
Reasons for discontinuation based on the reasons mentioned in Questionnaire	Approximately 2 years	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
Reasons for skipping treatment based on the reasons mentioned in Questionnaire	Approximately 2 years	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
Changes in physical functioning against clinical trial and long-term extension phase data based incidence of adverse events	Approximately 2 years	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