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

Active, not recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: tofacitinib; Drug: tumor necrosis factor inhibitors (TNFi); Drug: abatacept; Drug: tocilizumab or sarilumab

• Registration Number: NCT06418529
• Lead Sponsor: Pfizer

Brief Summary

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
...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Study Start: 2024-05-15
• Study First Posted: 2024-05-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20000

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rheumatoid arthritis	tumor necrosis factor inhibitors (TNFi)	Patients diagnosed with rheumatoid arthritis
rheumatoid arthritis	tocilizumab or sarilumab	Patients diagnosed with rheumatoid arthritis
rheumatoid arthritis	tofacitinib	Patients diagnosed with rheumatoid arthritis
rheumatoid arthritis	abatacept	Patients diagnosed with rheumatoid arthritis

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10.0	Months 6, 12

Trial Locations

Locations (1)

Pfizer; 🇺🇸 New York, New York, United States