A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day

NCT04267380 | Completed Results

• 1 other identifier: A3921359
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

Brief Summary

It is hypothesized that patients prescribed tofacitinib 11 mg Modified Release (MR) formulation once daily (QD) will achieve similar benefit to those prescribed tofacitinib 5 mg twice a day (BID) dosage in real world use. This study will therefore seek to compare the effectiveness of the MR 11 mg QD regimen to the IR 5 mg BID regimen for the treatment of RA in a real-world registry of RA patients.

Conditions

Arthritis Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline Upto 6 Months

  MCID improvement assessed based on Clinical disease activity index (CDAI). CDAI: numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 centimeter (cm) Visual analogue scale (VAS); CDAI total score = 0-76, higher scores=greater affection due to disease activity (DA). CDAI less than or equal to (\<=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 = low DA, \>10 to 22 = moderate DA, and \>22 = high DA. MCID improvement defined by difference in CDAI from baseline (at time of tofacitinib initiation) to 6 month visit. Participants were considered to show improvement from baseline on 3 cut points (1) greater than or equal (\>=) to 2 (for participants in low DA at baseline); (2) \>= 6 (moderate DA at baseline, and (3) \>= 11 (high DA at baseline). Here, overall number of participants who showed improvement have been reported.

  Baseline Up to 6 Months

Secondary Outcomes (19)

• Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6

  Baseline, Month 6

• Number of Participants Achieving Remission at Month 6 (All Participants)

  Month 6

• Number of Participants Achieving Remission at Month 6 (For Participants With Baseline CDAI >2.8)

  Month 6

• Number of Participants Achieving Low Disease Activity at Month 6 (All Participants)

  Month 6

• Number of Participants Achieving Low Disease Activity at Month 6 (Participants With Baseline CDAI >10)

  Month 6

Study Arms (2)

Corrona US RA Registry 11 mg

patients with RA who have been exposed to tofacitinib 11 mg QD tablet

Corrona US RA Registry 5 mg

patients with RA who have been exposed to tofacitinib 5 mg BID tablet

Eligibility Criteria

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

Study Population

Patients prescribed Tofacitinib in routine clinical practice

You may qualify if:

• All US Corrona RA Registry patients who initiated tofacitinib 5 mg twice a day (BID) or tofacitinib 11 mg once daily (QD) after it became available in February 2016
• Patients must have a follow-up visit at 6 months (+/- 3 months) after tofacitinib initiation. These 6 month visits are part of routine practice and is not associated with this protocol.
• Patients must have a valid clinical disease activity index (CDAI) at initiation and at 6-month follow-up visit

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10017, United States

Location

Related Publications (1)

• Cohen SB, Greenberg JD, Harnett J, Madsen A, Smith TW, Gruben D, Zhang R, Lukic T, Woolcott J, Dandreo KJ, Litman HJ, Blachley T, Lenihan A, Chen C, Rivas JL, Dougados M. Real-World Evidence to Contextualize Clinical Trial Results and Inform Regulatory Decisions: Tofacitinib Modified-Release Once-Daily vs Immediate-Release Twice-Daily for Rheumatoid Arthritis. Adv Ther. 2021 Jan;38(1):226-248. doi: 10.1007/s12325-020-01501-z. Epub 2020 Oct 9.

  PMID: 33034006 DERIVED

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: February 10, 2020
• First Posted: February 12, 2020
• Study Start: September 30, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: May 22, 2023
• Results First Posted: September 18, 2020

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)