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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 February 2016
• Main ID: NCT02598466
• Date of registration: 04/11/2015
• Prospective Registration: No
• Primary sponsor: Bristol-Myers Squibb
• Public title: Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa
• Scientific title: Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa
• Date of first enrolment: July 2015
• Target sample size: 69
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02598466
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective
• Phase: N/A

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Abatacept

Primary Outcome(s)

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 Outcome(s)

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 skipping treatment based on the reasons mentioned in Questionnaire [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 [Time Frame: Approximately 2 years]

Reasons for discontinuation based on the reasons mentioned in Questionnaire [Time Frame: Approximately 2 years]

Secondary ID(s)

IM101-572

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hexor, South Africa