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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 15 February 2016
Main ID:  NCT02598466
Date of registration: 04/11/2015
Prospective Registration: Yes
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
Countries of recruitment
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
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)
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]
Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients [Time Frame: Approximately 2 years]
Demographic characteristics (age, gender, education and population group) of patients [Time Frame: Approximately 2 years]
Reasons for discontinuation based on the reasons mentioned in Questionnaire [Time Frame: Approximately 2 years]
Reasons for skipping treatment 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
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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