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NCT04267380 · ClinicalTrials.gov registry record
A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day
A clinical trial of Arthritis, Rheumatoid, sponsored by Pfizer.
- Completed
- Registry status
- 298
- Enrollment target
- 1
- Study location
NCT04267380: Completed study of Arthritis, Rheumatoid, sponsored by Pfizer.
NCT04267380 is a study of Arthritis, Rheumatoid that has completed, run by Pfizer. The registered enrollment target is 298 participants, below the 630-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04267380, a study of Arthritis, Rheumatoid, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 298 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Study Locations (1)
New York
- Pfizer - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2018-09-30 |
| Est. Completion | 2019-08-31 |
What the finished NCT04267380 record still lists
NCT04267380 is an observational study that tracks outcomes without assigning an intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 630-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 0 interventions.
NCT04267380 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04267380 about?
NCT04267380 is a clinical study titled "A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day". 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...
What is the current status of trial NCT04267380?
This trial is currently completed. The enrollment target is 298 participants. The study started on 2018-09-30. Estimated completion is 2019-08-31.
What conditions does trial NCT04267380 study?
This clinical trial studies the following conditions: Arthritis, Rheumatoid.
Who is sponsoring clinical trial NCT04267380?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04267380 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04267380's enrollment target sits among peer trials
298 14th of 27 higher than 14 of 27 other Arthritis, Rheumatoid trials
participants (enrollment target), bucketed by value
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