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

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.
ClinicalTrials.gov Identifier: NCT03670667
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date September 7, 2018
First Posted Date September 13, 2018
Last Update Posted Date December 20, 2018
Actual Study Start Date February 22, 2017
Estimated Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2018)
  • Incidence of cancer among RA patients treated with abatacept [ Time Frame: Approximately 8 years ]
  • Incidence of cancer among RA patients treated with anti-TNF's [ Time Frame: Approximately 8 years ]
  • Incidence of cancer among RA patients treated with other biologics [ Time Frame: Approximately 8 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03670667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 12, 2018)
  • Incidence of cancer relative to the use of TNFi's in patients taking abatacept [ Time Frame: Approximately 8 years ]
  • Incidence of cancer relative to the use of other biologic disease modifiers in patients taking abatacept [ Time Frame: Approximately 8 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents
Official Title The Risk of Cancer Associated With the Use of Abatacept and Other Biologic Agents Among Rheumatoid Arthritis Patients
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The population will include patients who had incident cancer diagnosed from the SEER-Medicare linked database
Condition Rheumatoid Arthritis
Intervention Other: Non-Interventional
Non-Interventional
Study Groups/Cohorts
  • RA patients treated with abatacept
    Intervention: Other: Non-Interventional
  • RA patients treated with anti-TNFi's
    Intervention: Other: Non-Interventional
  • RA patients treated with other biologics
    Intervention: Other: Non-Interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 12, 2018)
1015
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 29, 2019
Estimated Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03670667
Other Study ID Numbers IM101-674
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date December 2018