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A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents

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ClinicalTrials.gov Identifier: NCT03670667
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
An observational study to determine the risk of cancer associated with the use of abatacept and other biologic agents among rheumatoid arthritis patients

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Non-Interventional

Study Type : Observational
Estimated Enrollment : 1015 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Risk of Cancer Associated With the Use of Abatacept and Other Biologic Agents Among Rheumatoid Arthritis Patients
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
RA patients treated with abatacept Other: Non-Interventional
Non-Interventional

RA patients treated with anti-TNFi's Other: Non-Interventional
Non-Interventional

RA patients treated with other biologics Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. Incidence of cancer among RA patients treated with abatacept [ Time Frame: Approximately 8 years ]
  2. Incidence of cancer among RA patients treated with anti-TNF's [ Time Frame: Approximately 8 years ]
  3. Incidence of cancer among RA patients treated with other biologics [ Time Frame: Approximately 8 years ]

Secondary Outcome Measures :
  1. Incidence of cancer relative to the use of TNFi's in patients taking abatacept [ Time Frame: Approximately 8 years ]
  2. Incidence of cancer relative to the use of other biologic disease modifiers in patients taking abatacept [ Time Frame: Approximately 8 years ]


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
The population will include patients who had incident cancer diagnosed from the SEER-Medicare linked database
Criteria

Inclusion Criteria:

  • RA patients will be identified using algorithms that require ≥ 1 rheumatologist (physician specialty code: 66) diagnosis codes for RA (at least one of the following ICD9 diagnosis codes: 714.0, 714.2, 714.81) at any time before the first claim for a specific drug (Index date) during the study period and ≥1 physician (affiliated with physician evaluation & management codes, listed in the appendix 2) diagnosis codes within 12 months before the first claim for a specific drug use. The index date is defined as the date of the first claim for a specific drug use, and the baseline period is defined as 12 months prior to specific drug use
  • Naive users of biologics, including abatacept, anti-TNFs (i.e. etanercept, adalimumab, certolizumab, golimumab, infliximab), rituximab, and tocilizumab, will be defined specific to each drug as no claim for that therapy in any time prior to the index date
  • Eligible subjects, including cancer patients in SEER and non-cancer beneficiaries from 5% sample, must have been continuously enrolled in Medicare Parts A, B and D and not C at their index date and during baseline

Exclusion Criteria:

  • Patients diagnosed with any cancer (ignoring non-melanoma skin cancer, which is not captured within SEER) before the use of biologics under study. Cancer cases will be identified based on the records in SEER
  • Patients who were younger than 18 years on the index date
  • Patients with claims for other types of auto-immune diseases (e.g. psoriatic arthritis, systemic lupus erythematosus) during baseline
  • Month or year of diagnosis of malignancy in SEER was unknown
  • Cancer cases who were identified by death certificate or autopsy only in SEER

Other protocol defined inclusion/exclusion criteria could apply


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): NCT03670667


Locations
United States, New Jersey
Local Institution
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03670667     History of Changes
Other Study ID Numbers: IM101-674
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents