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Safety Study of Abatacept to Treat Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01247766
Recruitment Status : Active, not recruiting
First Posted : November 24, 2010
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Arthritis Research Centre of Canada
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Observational Study Assessing the Long-term Safety of Abatacept Using a Population-based Cohort of Rheumatoid Arthritis Patients in the Province of British Columbia
Actual Study Start Date : December 31, 2010
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort
Patients with rheumatoid arthritis (RA) who receive abatacept
Patients with RA who receive BDM drugs
biologic disease-modifying (BDM)
Patients with RA who receive non-biologic DMARDs
disease-modifying anti-rheumatic drugs (DMARDs)



Primary Outcome Measures :
  1. Serious infection [ Time Frame: Every 2 years throughout the study ]
  2. Incidence rates of malignancy [ Time Frame: Every 2 years throughout the study ]
    (total, lymphoma, lung cancer, breast cancer, colorectal cancer)

  3. Total mortality [ Time Frame: Every 2 years throughout the study ]

Secondary Outcome Measures :
  1. Multiple sclerosis [ Time Frame: Every 2 years throughout the study ]
    To determine the incidence rate of multiple sclerosis (MS) in RA patients treated with abatacept and to compare this rate with the rate in RA patients matched for age, gender, RA duration and DMARD use, after adjusting for other potential confounders.



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:   Non-Probability Sample
Study Population
Residents of British Columbia who have received health care service for rheumatoid arthritis
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis
  • Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug
  • Age 18 years or older

Exclusion Criteria:

  • Below 18 years of age

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 ClinicalTrials.gov identifier (NCT number): NCT01247766


Sponsors and Collaborators
Bristol-Myers Squibb
Arthritis Research Centre of Canada
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01247766     History of Changes
Other Study ID Numbers: IM101-213
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Immunosuppressive Agents
Physiological Effects of Drugs
Antirheumatic Agents
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors