Skip to main content
OpenTrials
Completed

NCT Number: NCT04018001

Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR)

The purpose of this study is to compare adherence, persistence, and effectiveness among patients initiating tofacitinib Modified Release (MR) with tofacitinib Immediate Release (IR).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date

    Time frame: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

    Effectiveness criteria: 1) High adherence with proportion of days covered greater than or equal to [>=] 0.8; 2) No increase in index medication dose; 3) No use of an advanced therapy other than index therapy 4) No addition/claims of conventional synthetic disease-modifying antirheumatic drug; 5) If no oral glucocorticoid prescriptions in the 6 months prior to index date, then no more than 30 total days supply of oral glucocorticoids between 3-12 months post index or if at least 1 claim for oral glucocorticoids during 6 months pre-index, then oral glucocorticoid not increased by >=20% between 6-12 months post-index compared to 6 months before index date (6) Participants have one or fewer glucocorticoid injections during 3-12 months after index date. Adherence was defined as percentage of time with medication on hand. Participants who met all 6 effectiveness criteria considered as treated effectively.

  2. Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date

    Time frame: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

    Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

  3. Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date

    Time frame: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

    Adherence was defined as percentage of time with medication on hand. Participants with MPR >=0.8 were considered to show high adherence and participants with MPR less than (<) 0.8 were considered as low adherence. MPR was calculated as the total days supply of tofacitinib between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

  4. Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Medication Possession Ratio (MPR) up to 12 Months From the Index Date

    Time frame: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

    Adherence is defined as percentage of time with medication on hand. Participants with MPR >=0.8 were considered to show high adherence. MPR was calculated as the total days supply between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

  5. Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date

    Time frame: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

    Adherence was defined as percentage of time with medication on hand. Participants with PDC >= 0.8 were considered to show high adherence and participants with PDC <0.8 were considered to show low adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 360 days post-index.

  6. Primary: Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Proportion of Days Covered (PDC) up to 12 Months From the Index Date

    Time frame: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

    Adherence was defined as percentage of time with medication on hand. Participants with PDC >=0.8 were considered to show high adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 360 days post-index.

Secondary outcomes

  1. Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date

    Time frame: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

    Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

  2. Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date

    Time frame: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

    Adherence was defined as percentage of time with medication on hand. Participants with MPR >=0.8 were considered to show high adherence and participants with MPR <0.8 were considered to show low adherence. MPR was calculated as the total days supply of tofacitinib between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

  3. Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Medication Possession Ratio (MPR) up to 6 Months From the Index Date

    Time frame: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

    Adherence is defined as percentage of time with medication on hand. Participants with MPR >=0.8 were considered to show high adherence. MPR was calculated as the total days supply between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

  4. Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date

    Time frame: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

    Adherence was defined as percentage of time with medication on hand. Participants with PDC >= 0.8 were considered to show high adherence and participants with PDC <0.8 were considered to show low adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 180 days post-index.

  5. Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Proportion of Days Covered (PDC) up to 12 Months From the Index Date

    Time frame: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

    Adherence was defined as percentage of time with medication on hand. Participants with PDC >=0.8 were considered to show high adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 180 days post-index.

Other outcomes

  1. Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date

    Time frame: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

    Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

  2. Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date

    Time frame: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

    Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR) Formulation 11mg Once Daily (QD) and Tofacitinib Immediate Release (IR) Formulation 5 mg Twice Daily (BID) Within a United States (US) Healthcare Claims Database

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.