- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04267380
A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day
May 18, 2023 updated by: Pfizer
Compare Effectiveness of Tofacitinib 11 mg QD to Tofacitinib 5 mg BID
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
298
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10017
- Pfizer
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients prescribed Tofacitinib in routine clinical practice
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- There are no exclusion criteria for this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Corrona US RA Registry 11 mg
patients with RA who have been exposed to tofacitinib 11 mg QD tablet
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Corrona US RA Registry 5 mg
patients with RA who have been exposed to tofacitinib 5 mg BID tablet
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline Upto 6 Months
Time Frame: Baseline Up to 6 Months
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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.
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Baseline Up to 6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6
Time Frame: Baseline, Month 6
|
CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity.
CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Here, all participants who achieved remission (CDAI <=2.8) at Month 6 have been reported.
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Baseline, Month 6
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Number of Participants Achieving Remission at Month 6 (All Participants)
Time Frame: Month 6
|
CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity.
CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Here, all participants who achieved remission (CDAI <=2.8) at Month 6 have been reported.
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Month 6
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Number of Participants Achieving Remission at Month 6 (For Participants With Baseline CDAI >2.8)
Time Frame: Month 6
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CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity.
CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Here, only those participants who had baseline CDAI greater than 2.8, and who achieved remission (CDAI <= 2.8) at Month 6 have been reported.
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Month 6
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Number of Participants Achieving Low Disease Activity at Month 6 (All Participants)
Time Frame: Month 6
|
CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity.
CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Here, all participants who achieved low disease activity (CDAI > 2.8 to 10) at Month 6 have been reported.
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Month 6
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Number of Participants Achieving Low Disease Activity at Month 6 (Participants With Baseline CDAI >10)
Time Frame: Month 6
|
CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity.
CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Here, only those participants who had baseline CDAI greater than 10, and who achieved low disease activity (CDAI > 2.8 to 10) at Month 6 have been reported.
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Month 6
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Number of Participants With Decrease From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6
Time Frame: Month 6
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Modified HAQ: participant-reported questionnaire for the assessment of ability to perform tasks due to rheumatoid arthritis.
It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point.
Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Participants who had a baseline mHAQ score of >=0.25 were evaluable for this outcome measure and number of participants who had decrease from baseline in mHAQ score at Month 6 were reported.
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Month 6
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Number of Participants With Decrease From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6
Time Frame: Month 6
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HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis.
It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week.
Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Participants who had a baseline HAQ score of >=0.22 were evaluable for this outcome measure and number of participants who had decrease from baseline in HAQ score at Month 6 were reported.
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Month 6
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Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6: Dichotomous Variable
Time Frame: Baseline, Month 6
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Baseline, Month 6
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Change From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6
Time Frame: Baseline, Month 6
|
Modified HAQ: participant-reported questionnaire for the assessment of ability to perform tasks due to rheumatoid arthritis.
It comprised of 8 questions in 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week.
Eight item were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
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Baseline, Month 6
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Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6
Time Frame: Baseline, Month 6
|
HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis.
It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week.
Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
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Baseline, Month 6
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Change From Baseline in Modified Disease Activity Score Based on 28-joints Count (mDAS28) at Month 6
Time Frame: Baseline, Month 6
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Modified DAS28: Indicator of disease activity calculated as weighted average of six components: tender joint counts (TJC), swollen joint counts (SJC), mHAQ measure of disease activity, participant reported pain, physician reported global health assessment (PGA) and participant reported global health assessment (PtGA).
TJC and SJC calculated using 28 joints count; mHAQ scored on a scale of 0 to 3 (0 = least difficulty, 3 = extreme difficulty); participant reported pain scored on a scale of 0 to 100 (0 = no pain, 100= pain as bad as it could be); PGA and PtGA recorded on a visual analog scale (VAS) of 0 millimeter (mm) to 100 mm (0 = no disease activity and 100=high disease activity).
Transformed mDAS28 score ranged from 0 to 9.4, where higher scores indicated more disease activity.
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Baseline, Month 6
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Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) Erythrocyte Sedimentation Rate (ESR) at Month 6
Time Frame: Baseline, Month 6
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DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components.
The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and PtGA recorded on 100mm VAS (scores ranging 0 [very well] to 100 mm [extremely bad]).
DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of.
Total score range: 0 to 9.4, higher score indicated more disease activity.
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Baseline, Month 6
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Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) C- Reactive Protein (CRP) at 6 Month
Time Frame: Baseline, 6 months
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DAS28 is a measure of disease activity in participants with rheumatoid arthritis.
DAS28 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (milligrams per liter [mg/L]) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition).
DAS28 (CRP) was calculated as = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96.Total DAS28 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
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Baseline, 6 months
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Change From Baseline in Participant Pain Score at Month 6
Time Frame: Baseline, Month 6
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Participants were asked the following question to answer on a numeric rating scale (NRS): "How much pain have you had because of your arthritis in the past week?"
The scale ranged from 0-100, where 0=no pain and 100=pain as bad as it could be.
Higher scores indicated worsening of condition.
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Baseline, Month 6
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Change From Baseline in Participant Fatigue Score at Month 6
Time Frame: Baseline, Month 6
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Participants were asked the following question to answer on NRS: "How much of a problem has unusual fatigue of tiredness been for you in the past week?"
The scale ranged from 0-100, where 0=no fatigue and 100=fatigue as bad as it could be.
Higher scores indicated worsening of condition.
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Baseline, Month 6
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Change From Baseline in European Quality of Life- 5 Dimension (EQ-5D) Index at Month 6
Time Frame: Baseline, Month 6
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EQ-5D index: participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
It assesses level of current health in 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Each dimension had 3 levels: no problems (1), some problems (2) and severe problems (3).
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range 0 to 1, where 0=death and 1=perfect health; higher score indicates a better health state.
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Baseline, Month 6
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Number of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response
Time Frame: Month 6
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mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
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Month 6
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Number of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response
Time Frame: Month 6
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mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
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Month 6
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Number of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response
Time Frame: Month 6
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mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
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Month 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2018
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
August 31, 2019
Study Registration Dates
First Submitted
February 10, 2020
First Submitted That Met QC Criteria
February 10, 2020
First Posted (Actual)
February 12, 2020
Study Record Updates
Last Update Posted (Actual)
May 22, 2023
Last Update Submitted That Met QC Criteria
May 18, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3921359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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