An observational study in Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-08.
Sponsored by Bristol-Myers Squibb · Observational
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).
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 69 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Primary care clinic
Inclusion Criteria:
Drug: Abatacept
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
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
Time frame: Approximately 2 years
No study locations are listed for this record.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb