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The purpose of this study is to compare adherence, persistence, and effectiveness among patients initiating tofacitinib Modified Release (MR) with tofacitinib Immediate Release (IR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Truven Health MarketScan Research Database | individuals who are privately insured and with Medicare Supplemental insurance |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date | 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. | 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) |
| Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date | 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. | 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) |
| Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Individuals initiating tofacitinib
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33034006 | Derived | Cohen SB, Greenberg JD, Harnett J, Madsen A, Smith TW, Gruben D, Zhang R, Lukic T, Woolcott J, Dandreo KJ, Litman HJ, Blachley T, Lenihan A, Chen C, Rivas JL, Dougados M. Real-World Evidence to Contextualize Clinical Trial Results and Inform Regulatory Decisions: Tofacitinib Modified-Release Once-Daily vs Immediate-Release Twice-Daily for Rheumatoid Arthritis. Adv Ther. 2021 Jan;38(1):226-248. doi: 10.1007/s12325-020-01501-z. Epub 2020 Oct 9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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/data\_requests.
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The study was a retrospective follow-up study of participants treated with index medication (tofacitinib) and enrolled in a health insurance plan for a minimum of 24 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib Modified Release (MR) | Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study. |
| FG001 | Tofacitinib Immediate Release (IR) | Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis was performed on all participants included in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib Modified Release (MR) | Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date | 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. | Analysis was performed on all participants included in the study. | Posted | Number | percentage of participants | 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) |
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Due to the nature of claims data base from which these data where queried, no adverse events were collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib Modified Release (MR) | Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2019 | Mar 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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) |
| 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 | 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. | 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) |
| Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date | 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. | 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) |
| 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 | 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. | 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) |
| 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) |
| Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date | 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. | 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) |
| 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 | 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. | 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) |
| Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date | 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. | 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) |
| 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 | 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. | 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) |
| 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) |
| Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date | 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. | 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) |
| BG001 | Tofacitinib Immediate Release (IR) | Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Combination Therapy | Combination therapy was defined as first comedication with any Conventional synthetic disease-modifying antirheumatic drug (csDMARD). | Number | participants |
|
| Use of non-steroidal antiinflammatory drug (NSAID)s Pre-Index | Participants who took NSAIDs before index date were reported. | Number | participants |
|
| Number of Advanced Therapies At Index | Participants who took no advance therapy (0), 1 advance therapy (1) 2 advance therapies (2), and atleast 3 advance therapies (>=3) were reported. | Number | advanced therapies |
|
| Insurance type | Number | participants |
|
| Region | Number | participants |
|
| Year and month of the participant's index date | Number | participants |
|
| Index Medication | Participants who took index medication were reported. | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Tofacitinib Modified Release (MR) | Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study. |
| OG001 | Tofacitinib Immediate Release (IR) | Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study. |
|
|
|
| Primary | Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date | 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. | Analysis was performed on all participants included in the study. Here "Overall number of participants analyzed" signifies only those participants who had data available. | Posted | Mean | Standard Deviation | days | 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) |
|
|
|
|
| Primary | Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date | 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. | Analysis was performed on all participants included in the study. | Posted | Mean | Standard Deviation | ratio | 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) |
|
|
|
|
| Primary | 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 | 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. | Analysis was performed on all participants included in the study. | Posted | Number | percentage of participants | 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) |
|
|
|
|
| Primary | Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date | 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. | Analysis was performed on all participants included in the study. | Posted | Mean | Standard Deviation | ratio | 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) |
|
|
|
|
| Primary | 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 | 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. | Analysis was performed on all participants included in the study. | Posted | Number | percentage of participants | 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) |
|
|
|
|
| Secondary | Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date | 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. | Analysis was performed on all participants included in the study. | Posted | Mean | Standard Deviation | days | 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) |
|
|
|
|
| Secondary | Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date | 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. | Analysis was performed on all participants included in the study. | Posted | Mean | Standard Deviation | ratio | 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) |
|
|
|
|
| Secondary | 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 | 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. | Analysis was performed on all participants included in the study. | Posted | Number | percentage of participants | 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) |
|
|
|
|
| Secondary | Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date | 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. | Analysis was performed on all participants included in the study. | Posted | Mean | Standard Deviation | ratio | 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) |
|
|
|
|
| Secondary | 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 | 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. | Analysis was performed on all participants included in the study. | Posted | Number | percentage of participants | 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) |
|
|
|
|
| Other Pre-specified | Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date | 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. | Analysis was performed on all participants included in the study. | Posted | Number | percentage of participants | 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) |
|
|
|
|
| Other Pre-specified | Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date | 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. | Analysis was performed on all participants included in the study. | Posted | Number | percentage of participants | 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) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Tofacitinib Immediate Release (IR) | Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Hazard Ratio (HR) |
| 0.9022 |
| 2-Sided |
| 95 |
| 0.7534 |
| 1.0803 |
| Superiority |
| Difference in Least Squares (LS) Means |
| 0.0300853 |
| 2-Sided |
| 95 |
| 0.0092322 |
| 0.0509385 |
| Superiority |
| Odds Ratio (OR) |
| 1.7910474 |
| 2-Sided |
| 95 |
| 1.3167136 |
| 2.4362554 |
| Superiority |
| Difference in LS Means |
| 0.0104065 |
| 2-Sided |
| 95 |
| -0.030062 |
| 0.0508746 |
| Superiority |
| Odds Ratio (OR) |
| 1.5211586 |
| 2-Sided |
| 95 |
| 1.1594614 |
| 1.9956882 |
| Superiority |
| Hazard Ratio (HR) |
| 1.1225 |
| 2-Sided |
| 95 |
| 0.8873 |
| 1.4201 |
| Superiority |
| Difference in LS Means |
| 0.0151242 |
| 2-Sided |
| 95 |
| -0.003908 |
| 0.0341568 |
| Superiority |
| Odds Ratio (OR) |
| 1.4143816 |
| 2-Sided |
| 95 |
| 1.0221455 |
| 1.9571335 |
| Superiority |
| Difference in LS Means |
| -0.008587 |
| 2-Sided |
| 95 |
| -0.044317 |
| 0.0271416 |
| Superiority |
| Odds Ratio (OR) |
| 1.1077385 |
| 2-Sided |
| 95 |
| 0.8489444 |
| 1.4454238 |
| Superiority |