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

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab or sarilumab; Drug: abatacept; Drug: tofacitinib; Drug: tumor necrosis factor inhibitors (TNFi)

Study type: Observational

Funder types: Industry

Identifiers

NCT06418529

NCT06418529 (Registry Identifier)

A3921445

Details and patient eligibility

About

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.

Enrollment: 21,340 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

21,340 participants in 1 patient group

rheumatoid arthritis

Description:

Patients diagnosed with rheumatoid arthritis

Treatment:

Drug: tumor necrosis factor inhibitors (TNFi)

Drug: tofacitinib

Drug: abatacept

Drug: tocilizumab or sarilumab