## Protocol Section
### Identification Module
**NCT ID:** NCT06418529

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

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

#### Organization Study ID Info
**ID:** A3921445
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**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
* 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.

### Conditions Module

**Conditions:**

- Rheumatoid Arthritis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 20000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients diagnosed with rheumatoid arthritis

**Intervention Names:**

- Drug: tofacitinib

- Drug: tumor necrosis factor inhibitors (TNFi)

- Drug: abatacept

- Drug: tocilizumab or sarilumab

**Label:** rheumatoid arthritis

### Interventions

#### Intervention 1

**Arm Group Labels:**

- rheumatoid arthritis

**Description:** New index treatment of tofacitinib

**Name:** tofacitinib

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- rheumatoid arthritis

**Description:** New index treatment of TNFi

**Name:** tumor necrosis factor inhibitors (TNFi)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- rheumatoid arthritis

**Description:** New index treatment of abatacept

**Name:** abatacept

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- rheumatoid arthritis

**Description:** New index treatment of tocilizumab or sarilumab

**Name:** tocilizumab or sarilumab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10.0

**Time Frame:** Months 6, 12

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ClinicalTrials.gov_Inquiries@pfizer.com

**Name:** Pfizer CT.gov Call Center

**Phone:** 1-800-718-1021

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Pfizer

**Name:** Pfizer CT.gov Call Center

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**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.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: HIGH

- As Found: Rheumatoid Arthritis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001172

- Term: Arthritis, Rheumatoid

### Intervention Browse Module - Ancestors

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000075242

- Term: Janus Kinase Inhibitors

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000000893

- Term: Anti-Inflammatory Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M2052

- Name: Tumor Necrosis Factor Inhibitors

- Relevance: HIGH

- As Found: Celiac artery

- ID: M483

- Name: Abatacept

- Relevance: HIGH

- As Found: Oxygenation

- ID: M258018

- Name: Tofacitinib

- Relevance: HIGH

- As Found: Burn

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M1474

- Name: Janus Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000079424

- Term: Tumor Necrosis Factor Inhibitors

- ID: D000069594

- Term: Abatacept

- ID: C000479163

- Term: Tofacitinib

### Misc Info Module

- Version Holder: 2024-05-31
