A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis

Comparative Effectiveness of New Initiators of Tofacitinib and Other Biologic/Targeted Synthetic DMARDs in Patients With Rheumatoid Arthritis

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:

• Tofacitinib
• Abatacept
• Tocilizumab or sarilumab

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: tofacitinib; Drug: tumor necrosis factor inhibitors (TNFi); Drug: abatacept; Drug: tocilizumab or sarilumab

• Study Type: Observational
• Enrollment (Actual): 20000

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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 PremiOM™ 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 PremiOM™ RA dataset will include the time period from 01 January 2013 through 31 December 2023.

Description

Inclusion Criteria:

1. Age ≥18 years on the cohort entry date.

2. Diagnosed with rheumatoid arthritis (RA) at any time prior to cohort entry date:

   1. At least two RA diagnosis codes at least 30 days apart, each coming from an encounter with a rheumatologist;
   2. At least one inpatient visit with a RA diagnosis code;
   3. At least two outpatient records with a RA diagnosis code at least 30 days apart and within a year, regardless of physician specialty; or
   4. At least one outpatient record with an RA diagnosis and a prescription or fill for a disease modifying anti-rheumatic drug (DMARD) from a specified list and does not have any of the non-RA conditions for which those drugs may also be prescribed.
3. 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).
4. At least 180 days of baseline data available prior to and including the cohort entry date.
5. At least one Clinical Disease Activity Index (CDAI) score in 45 days prior to and including the cohort entry date (baseline).

Exclusion Criteria:

1. Patients diagnosed with concomitant indications for tofacitinib [psoriatic arthritis (PsA), UC, and polyarticular course juvenile idiopathic arthritis (pcJIA)] at any time prior to cohort entry date, determined by at least two (2) diagnosis codes at least 30 days apart and prior to baseline.
2. Patients with >1 b/tsDMARD (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept tocilizumab, or sarilumab) prescribed on index date.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
rheumatoid arthritis; Patients diagnosed with rheumatoid arthritis	Drug: tofacitinib; New index treatment of tofacitinib; Drug: tumor necrosis factor inhibitors (TNFi); New index treatment of TNFi; Drug: abatacept; New index treatment of abatacept; Drug: tocilizumab or sarilumab; New index treatment of tocilizumab or sarilumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10.0	Months 6, 12

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Janus Kinase Inhibitors; Abatacept; Tofacitinib; Tumor Necrosis Factor Inhibitors
• Other Study ID Numbers: A3921445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No