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Completed

NCT Number: NCT06418529

A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years on the cohort entry date.
  • Diagnosed with rheumatoid arthritis (RA) at any time prior to cohort entry date:
  • At least two RA diagnosis codes at least 30 days apart, each coming from an encounter with a rheumatologist;
  • At least one inpatient visit with a RA diagnosis code;
  • At least two outpatient records with a RA diagnosis code at least 30 days apart and within a year, regardless of physician specialty; or
  • 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.
  • 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).
  • At least 180 days of baseline data available prior to and including the cohort entry date.
  • At least one Clinical Disease Activity Index (CDAI) score in 45 days prior to and including the cohort entry date (baseline).

Exclusion criteria

  • 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.
  • Patients with >1 b/tsDMARD (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept tocilizumab, or sarilumab) prescribed on index date.

Treatment and study plan

tofacitinib

Drug

New index treatment of tofacitinib

tumor necrosis factor inhibitors (TNFi)

Drug

New index treatment of TNFi

Abatacept

Drug

New index treatment of abatacept

tocilizumab or sarilumab

Drug

New index treatment of tocilizumab or sarilumab

Primary outcomes

  1. Incidence Rate of Low Disease Activity (LDA) or Remission Based on Clinical Disease Activity Index (CDAI) at 6-Months Follow-up: Tofacitinib vs. TNFi

    Time frame: During 6 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)

    CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: swollen joint counts (SJC) and tender/painful joint counts (TJC) (score range from 0 to 28, higher scores = worse condition), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA) (assessed on 0-10 centimeter [cm)] visual analog scale [VAS]; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. Inverse probability of treatment weighting (IPTW) using stabilized weights to adjust for baseline confounders, was used for analysis.

  2. Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. TNFi

    Time frame: During 12 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)

    CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis.

  3. Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. Abatacept

    Time frame: During 6 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)

    CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis.

  4. Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept

    Time frame: During 12 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)

    CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis.

  5. Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. IL-6

    Time frame: During 6 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)

    CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis.

  6. Incident Rate of Low Disease Activity or Remission Based on CDAI at Month 12: Tofacitinib vs. IL-6, IPTW

    Time frame: During 12 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)

    CDAI was a simplified index for assessing disease activity comprising of the SJC, tender/painful joint counts TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to 10 in participants with moderate or high disease activity CDAI greater than 10 at baseline. IPTW method was used for analysis of this outcome measure.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 17, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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