A Study To Investigate And Describe The Treatment Patterns And Effect Of Tofacitinib Indicators For Patients With Rheumatoid Arthritis

NCT04721808 | Completed Results

• 1 other identifier: A3921379
• Study Type: observational
• Target: 1,712
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate and describe the treatment patterns and effect of tofacitinib indicators for patients with Rheumatoid Arthritis (RA) assessing real world patient data entered in the Corrona RA Registry on or after November 2012

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators

  CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count and swollen joint count (both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a visual analog scale (VAS) from 0 to 100 millimeter (mm); higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; between \>10 and \<=22 indicated moderate disease activity and \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.

  At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators

  CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count (TJC) and swollen joint count (\[SJC\] both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.

  At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy

  CDAI=composite index for assessing disease activity (DA) based on summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate DA and score \>22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any disease modifying antirheumatic drug \[DMARD\]) and by each line of therapy, second line: participants with prior use of at least 1 conventional synthetic (cs) DMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.

  At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy

  CDAI=composite index for assessing DA based on numerical summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate DA and score \>22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy, second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.

  At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose

  CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg twice daily (BID) or 11 mg once daily (QD).

  At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose

  CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg BID or 11 mg QD.

  At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation

  CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020).

  At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation

  CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020).

  At 12 months after tofacitinib initiation (from the data retrieved and observed for approximately 10 months of this retrospective study)

Secondary Outcomes (40)

• Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators

  At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators

  Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators

  Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators

  Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)

• Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators

  Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)

Study Arms (1)

Patients with Rheumatoid Arthritis (RA)

Patients receiving tofacitinib from the Corrona RA Registry from November 2012 onward

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be collected from the Corrona RA Registry. The Corrona registry is a prospective, multicenter, observational disease-based registry launched in 2001.

You may qualify if:

• Enrolled in the Corrona RA Registry and initiated tofacitinib on or after November 2012
• Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment visit or at a Corrona follow-up visit from November 2012 onward.
• Have CDAI measured at baseline
• Have at least a 6-month follow-up visit and CDAI measured at the 6-month follow-up visit

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10017, United States

Location

Related Publications (1)

• Pappas DA, O'Brien J, Moore PC, Dodge R, Germino R, Masri KR, Bingham CO 3rd, Cappelli LC. Treatment Patterns and Effectiveness of Tofacitinib in Patients Initiating Therapy for Rheumatoid Arthritis: Results From the CorEvitas Rheumatoid Arthritis Registry. J Rheumatol. 2024 May 1;51(5):452-461. doi: 10.3899/jrheum.2023-0752.

  PMID: 38359941 DERIVED

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

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: January 19, 2021
• First Posted: January 25, 2021
• Study Start: January 22, 2021
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: September 29, 2023
• Results First Posted: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)