Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics

Back to Search
Print
Bookmark Trial

NCT03964649

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer
New York, New York, 10017, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- At least one claim for methotrexate during the variable-length pre-index period.

- At least one claim for tofacitinib or bDMARDs between 01 February 2016 and 31 July 2019 (the identification period).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with claims for other conditions for which bDMARDs are used during the
one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's
disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from
the study.


- Patients with evidence of the index medication during the one-year pre-index period
will be removed from the analysis. Patients will be allowed to have been treated with
(other) bDMARDs during the one-year pre-index period.


- Patients with more than 1 bDMARD or bDMARD with tofacitinib filled on the index date
will be removed from the study.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Rheumatoid ArthritisStudy To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients
NCT04428424
  1. Baghdad,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisTO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
NCT04413617
  1. Winnipeg, Manitoba
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisStudy Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis
NCT00141830
  1. Largo, Florida
  2. Palm Harbor, Florida
  3. Sarasota, Florida
  4. Boise, Idaho
  5. Kansas City, Kansas
  6. Frederick, Maryland
  7. Albuquerque, New Mexico
  8. Charlotte, North Carolina
  9. Duncansville, Pennsylvania
  10. Austin, Texas
  11. Dallas, Texas
  12. San Antonio, Texas
  13. Spokane, Washington
  14. La Crosse, Wisconsin
  15. Penticton, British Columbia
  16. Newmarket, Ontario
  17. Toronto, Ontario
  18. Montréal, Quebec
  19. Trois-Rivières, Quebec
  20. Saskatoon, Saskatchewan
  21. Quebec,
  22. Budapest,
  23. Békéscsaba,
  24. Veszprém,
  25. Brescia,
  26. Genova,
  27. Pavia,
  28. Roma,
  29. Siena,
  30. Jalisco, Guadalajara
  31. Delegacion Cuahutemoc,
  32. Andalucia,
  33. Castilla la Mancha,
  34. Comunidad Valenciana,
  35. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisStudy Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
NCT01059864
  1. Birmingham, Alabama
  2. Huntsville, Alabama
  3. Gilbert, Arizona
  4. Scottsdale, Arizona
  5. Upland, California
  6. Jacksonville, Florida
  7. Dayton, Ohio
  8. Mayfield Village, Ohio
  9. Greenville, South Carolina
  10. Allen, Texas
  11. Seoul,
  12. Seoul,
  13. Seoul,
  14. Seoul,
  15. Seoul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics
Official Title Comparative Analysis of Outcomes Among Rheumatoid Arthritis Patients Treated With Xeljanz Versus Biologic DMARDs Using a United States Healthcare Claims Database
Brief Summary To compare rheumatoid arthritis (RA) patient characteristics, adherence, and costs between patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs.
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 Non-Probability Sample
Study Population This study will utilize the de-identified claims data in the Truven Health MarketScan Research Database.
Condition Arthritis, Rheumatoid
Intervention Not Provided
Study Groups/Cohorts Truven Health MarketScan Research Database
To compare RA-related costs among patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs (individually, as well as to TNFi and to non-TNFi each combined as groups).
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 Completed
Actual Enrollment
 (submitted: May 24, 2019)		1
Original Actual Enrollment Same as current
Actual Study Completion Date April 6, 2020
Actual Primary Completion Date April 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • At least one claim for methotrexate during the variable-length pre-index period.
  • At least one claim for tofacitinib or bDMARDs between 01 February 2016 and 31 July 2019 (the identification period).

Exclusion Criteria:

  • Patients with claims for other conditions for which bDMARDs are used during the one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study.
  • Patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. Patients will be allowed to have been treated with (other) bDMARDs during the one-year pre-index period.
  • Patients with more than 1 bDMARD or bDMARD with tofacitinib filled on the index date will be removed from the study.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, 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 NCT03964649
Other Study ID Numbers A3921305
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020