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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06418529 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn how different types of medicines may improve disease activity in people with rheumatoid arthritis (RA). RA is a kind of joint disease that causes pain and swelling.
The study will look at data from a large, US-based group of RA patients who have taken the below medicines:
The study will compare clinical disease activity scores of patients on the different medicines taken. The study will also decide whether some patient traits or disease factors play a role in how medicines may improve disease activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rheumatoid arthritis | Patients diagnosed with rheumatoid arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib | Drug | New index treatment of tofacitinib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Low Disease Activity (LDA) or Remission Based on Clinical Disease Activity Index (CDAI) at 6-Months Follow-up: Tofacitinib vs. TNFi | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: swollen joint counts (SJC) and tender/painful joint counts (TJC) (score range from 0 to 28, higher scores = worse condition), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA) (assessed on 0-10 centimeter [cm)] visual analog scale [VAS]; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. Inverse probability of treatment weighting (IPTW) using stabilized weights to adjust for baseline confounders, was used for analysis. | During 6 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
| Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. TNFi | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. | During 12 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
| Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. Abatacept |
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Inclusion Criteria:
Age ≥18 years on the cohort entry date.
Diagnosed with rheumatoid arthritis (RA) at any time prior to cohort entry date:
Initiation of specified biologic or targeted synthetic molecule DMARDs of interest for treatment of RA (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept, tocilizumab, or sarilumab).
At least 180 days of baseline data available prior to and including the cohort entry date.
At least one Clinical Disease Activity Index (CDAI) score in 45 days prior to and including the cohort entry date (baseline).
Exclusion Criteria:
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A retrospective design will be used to explore the comparative effectiveness of tofacitinib among a cohort of patients with rheumatoid arthritis (RA) in the U.S. using the OM1 PremiOMâ„¢ RA dataset (OM1, Inc., Boston, MA). This dataset of over 244,000 patients with RA is derived from deterministically linked, de-identified, individual-level healthcare claims and electronic medical record (EMR) data. EMR data are derived from several healthcare systems and rheumatologist's EMR provider systems geographically representative of the U.S. population. For this analysis, the OM1 PremiOMâ„¢ RA dataset will include the time period from 01 January 2013 through 31 December 2023.
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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 |
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| 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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Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months).
Eligible retrospective data retrieved from US based OM1 PremiOMâ„¢ Rheumatoid Arthritis (RA)dataset (OM1, Inc., Boston, MA) from 1 Jan 2013 to 13 Mar 2024 (approximately 11.2 years). Dataset included participants diagnosed with RA in routine clinical care among network of rheumatologists across US. Participants who initiated treatment with tofacitinib or comparator (tumor necrosis factor inhibitor [TNFi], abatacept, interleukin 6 [IL-6]) were assigned to respective reporting groups for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib | Participants diagnosed with RA and who initiated treatment with tofacitinib, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different targeted synthetic/biologic (ts/b)DMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 7, 2024 |
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| tumor necrosis factor inhibitors (TNFi) |
| Drug |
New index treatment of TNFi |
|
| abatacept | Drug | New index treatment of abatacept |
|
| tocilizumab or sarilumab | Drug | New index treatment of tocilizumab or sarilumab |
|
CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. |
| During 6 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
| Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. | During 12 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
| Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. IL-6 | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. | During 6 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
| Incident Rate of Low Disease Activity or Remission Based on CDAI at Month 12: Tofacitinib vs. IL-6, IPTW | CDAI was a simplified index for assessing disease activity comprising of the SJC, tender/painful joint counts TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to 10 in participants with moderate or high disease activity CDAI greater than 10 at baseline. IPTW method was used for analysis of this outcome measure. | During 12 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
| FG001 | TNFi | Participants diagnosed with RA and who initiated treatment with TNFi, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
| FG002 | Abatacept | Participants diagnosed with RA and who initiated treatment with abatacept, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
| FG003 | IL-6 | Participants diagnosed with RA and who initiated treatment with IL-6, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
| COMPLETED |
|
| NOT COMPLETED |
|
Analysis population included all eligible participants whose data were retrieved from dataset and observed retrospectively in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib | Participants diagnosed with RA and who initiated treatment with tofacitinib, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
| BG001 | TNFi | Participants diagnosed with RA and who initiated treatment with TNFi, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
| BG002 | Abatacept | Participants diagnosed with RA and who initiated treatment with abatacept, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
| BG003 | IL-6 | Participants diagnosed with RA and who initiated treatment with IL-6, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Incidence Rate of Low Disease Activity (LDA) or Remission Based on Clinical Disease Activity Index (CDAI) at 6-Months Follow-up: Tofacitinib vs. TNFi | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: swollen joint counts (SJC) and tender/painful joint counts (TJC) (score range from 0 to 28, higher scores = worse condition), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA) (assessed on 0-10 centimeter [cm)] visual analog scale [VAS]; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. Inverse probability of treatment weighting (IPTW) using stabilized weights to adjust for baseline confounders, was used for analysis. | Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study. | Posted | Number | Events per 1000 person years | During 6 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
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| Primary | Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. TNFi | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. | Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study. | Posted | Number | Events per 1000 person years | During 12 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
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| Primary | Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. Abatacept | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. | Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study. | Posted | Number | Events per 1000 person years | During 6 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
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| Primary | Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. | Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study. | Posted | Number | Events per 1000 person years | During 12 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
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| Primary | Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. IL-6 | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. | Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study. | Posted | Number | Events per 1000 person years | During 6 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
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| Primary | Incident Rate of Low Disease Activity or Remission Based on CDAI at Month 12: Tofacitinib vs. IL-6, IPTW | CDAI was a simplified index for assessing disease activity comprising of the SJC, tender/painful joint counts TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to 10 in participants with moderate or high disease activity CDAI greater than 10 at baseline. IPTW method was used for analysis of this outcome measure. | Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study. | Posted | Number | Events per 1000 person years | During 12 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) |
|
Not applicable as adverse events and all-cause mortality were not planned to be assessed, which explains "at risk" as "0"
Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not planned to be assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib | Participants diagnosed with RA and who initiated treatment with tofacitinib, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | TNFi | Participants diagnosed with RA and who initiated treatment with TNFi, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Abatacept | Participants diagnosed with RA and who initiated treatment with abatacept, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | IL-6 | Participants diagnosed with RA and who initiated treatment with IL-6, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. | 0 | 0 | 0 | 0 | 0 | 0 |
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Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Jul 14, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D000079424 | Tumor Necrosis Factor Inhibitors |
| D000069594 | Abatacept |
| C502936 | tocilizumab |
| C000592401 | sarilumab |
| ID | Term |
|---|---|
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| White |
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| Other |
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| Unknown |
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| OG001 | TNFi | Participants diagnosed with RA and who initiated treatment with TNFi, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
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| OG001 | Abatacept | Participants diagnosed with RA and who initiated treatment with abatacept, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
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| OG001 | Abatacept | Participants diagnosed with RA and who initiated treatment with abatacept, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
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| OG001 | IL-6 | Participants diagnosed with RA and who initiated treatment with IL-6, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
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| OG001 | IL-6 | Participants diagnosed with RA and who initiated treatment with IL-6, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. |
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