Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX
Completed
Conditions studied: Rheumatoid Arthritis
In brief
To address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in RA patients newly initiating tofacitinib in combination with oral methotrexate (MTX)
Key facts
- Study ID
- NCT03975790
- Run by
- Pfizer
- People needed
- 479
- Starts
- 2018-05-29
- Expected to finish
- 2018-10-02
- Last updated by the study team
- 2023-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least one claim for tofacitinib between 01 January 2014 and 31 January 2017 (the identification period).
- Presence of The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) code for RA (in any position) during the one-year pre-index period or on the index date. ICD-9 = 714.0x-714.4x \& 714.81 or ICD10 = M05.* \& M06.0*-M06.3* or M06.8*-M06.9*.
- At least 18 years old as of the index date.
You may not qualify if…
- Patients with claims for other conditions for which biologics 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 biologics approved for RA (Tumor-Necrosis Factor-alpha inhibitors (TNFi) [adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), golimumab (Simponi), infliximab (Remicade)] and non-TNFi's with alternative mechanisms of action [abatacept (Orencia), and rituximab (Rituxan), anakinra (Kineret), tocilizumab (Actemra)]) during the one-year pre-index period.
Where it is running
- Pfizer — New York, New York, United States
Full record on ClinicalTrials.gov
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