A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients

NCT04047121 | Completed Results

• 1 other identifier: A3921346
• Study Type: observational
• Target: 1,349
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients initiating treatment comparator groups of interest between January 2014 and September 2016 across three United States insurance claims databases.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date

  Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Index medications were tofacitinib, adalimumab or etanercept.

  During 12 months post-index date

• Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date

  Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept.

  During 12 months post-index date

• Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date

  Participants who discontinued index medication then switched from index medication were those who had gap in the index medication therapy of at least 60 days and then after the gap they switched to an advanced therapy different from index medication. Index medications were tofacitinib, adalimumab or etanercept.

  During 12 months post-index date

• Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date

  Participants who discontinued index medication and then restarted index medication were those who had a gap in the index medication therapy of at least 60 days and the first advanced therapy observed after the gap was the index medication. Index medications were tofacitinib, adalimumab or etanercept.

  During 12 months post index date

• Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date

  Participants who discontinued index medication without switching or restarting index medication were those who had a gap in index medication therapy of at least 60 days and there were no claims for either the index medication or a different advanced therapy for the remainder of the follow-up period. Index medications were tofacitinib, adalimumab or etanercept.

  During 12 months post index date

Secondary Outcomes (37)

• Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date

  During 12 months post-index date

• Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date

  During 12 months post-index date

• Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date

  During 12 month post-index date

• Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date

  During 12 months post-index date

• Duration of Index Medication Persistent Therapy During 12 Months Post-index Date

  During 12 months post-index date

Study Arms (1)

Truven Health MarketScan

The Truven Health MarketScan Research Databases reflects the combined healthcare service use of individuals covered by Truven Health clients (including employers, health plans, and hospitals) nationwide.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients

You may qualify if:

• first pharmacy claim for Tofacitinib and then Etanercept or Adalimumab between Jan 2014 and Sep 2016 represents the index claim
• First, select patients receiving ≥1 Tofacitinib pharmacy claim (Jan 2014-Sep 2016) who did not have a Tofacitinib claim anytime prior to index
• Patients do have \>1 advanced therapy filled on index date
• Physician diagnosis of Rheumatoid Arthritis (in any position) during the 1-year pre-index period, or on the index date
• Age 18+ years at index

You may not qualify if:

• None

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Collegeville, Pennsylvania, 19426, United States

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Prioritization for outcome measures was per study team's discretion.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 6, 2019
• Study Start: May 20, 2019
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: June 9, 2023
• Results First Posted: October 19, 2020

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)