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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02598466
Recruitment Status : Completed
First Posted : November 6, 2015
Last Update Posted : February 8, 2016
Hexor, South Africa
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Abatacept

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Abatacept Drug: Abatacept

Primary Outcome Measures :
  1. 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 Measures :
  1. Demographic characteristics (age, gender, education and population group) of patients [ Time Frame: Approximately 2 years ]
  2. Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients [ Time Frame: Approximately 2 years ]
  3. Reasons for discontinuation based on the reasons mentioned in Questionnaire [ Time Frame: 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

  4. Reasons for skipping treatment based on the reasons mentioned in Questionnaire [ Time Frame: 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

  5. Association of demographic and clinical characteristics based on Standard Disability Index of the Health Assessment Questionnaire (HAQ-DI) scores [ Time Frame: Approximately 2 years ]
  6. Changes in physical functioning against clinical trial and long-term extension phase data based incidence of adverse events [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02598466

Sponsors and Collaborators
Bristol-Myers Squibb
Hexor, South Africa
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT02598466     History of Changes
Other Study ID Numbers: IM101-572
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Connective Tissue Diseases
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents