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

Rheumatoid Arthritis Clinical Trial

Official title:

Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598466
• Other study ID #: IM101-572
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: February 5, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: None
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Hexor, South Africa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Demographic characteristics (age, gender, education and population group) of patients		Approximately 2 years	No
Secondary	Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients		Approximately 2 years	No
Secondary	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	Approximately 2 years	No
Secondary	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	Approximately 2 years	No
Secondary	Association of demographic and clinical characteristics based on Standard Disability Index of the Health Assessment Questionnaire (HAQ-DI) scores		Approximately 2 years	No
Secondary	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	Approximately 2 years	Yes

External Links

•   BMS Clinical Trial Information
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