- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT04721821
Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.
2022. június 8. frissítette: Pfizer
Comparative Effectiveness of Tumor Necrosis Factor (TNF) Inhibitors and Tofacitinib, Overall, by Line of Therapy and by Combination Therapy
This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.
A tanulmány áttekintése
Tanulmány típusa
Megfigyelő
Beiratkozás (Tényleges)
4012
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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New York
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New York, New York, Egyesült Államok, 10017
- Pfizer
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
Data will be collected from the Corrona RA Registry.
The Corrona RA Registry is a prospective, multicenter, observational disease-based registry.
Leírás
Inclusion Criteria:
- RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis
- Have a 6 and / or 12-month follow-up visit (with +/- 2 month window)
- Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit
Exclusion Criteria:
- Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
---|---|
Patients with Rheumatoid Arthritis (RA)
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Patients who received Tofacitinib for RA
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of participants achieving low disease activity at 6 months
Időkeret: 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 <=10) at Month 6 have been reported.
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Month 6
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of participants achieving remission at month 6
Időkeret: 6 months
|
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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6 months
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Number of participants achieving remission at month 12
Időkeret: 12 months
|
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 12 have been reported.
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12 months
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Number of participants achieving low disease activity at month 12
Időkeret: 12 months
|
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 <=10) at Month 12 have been reported.
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12 months
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Number of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response
Időkeret: 6 months
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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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6 months
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Number of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response
Időkeret: 6 months
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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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6 months
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Number of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response
Időkeret: 6 months
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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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6 months
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Number of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response
Időkeret: 12 months
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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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12 months
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Number of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response
Időkeret: 12 months
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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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12 months
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Number of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response
Időkeret: 12 months
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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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12 months
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Number of Participants with mild pain
Időkeret: 6 months
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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.
Participants who had a baseline pain score of >= 20 were evaluable for this outcome measure and number of participants who a pain score less than or equal to 20 at Month 6 were reported.
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6 months
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Number of Participants with mild pain
Időkeret: 12 months
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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.
Participants who had a baseline pain score of >= 20 were evaluable for this outcome measure and number of participants who a pain score less than or equal to 20 at Month 12 were reported.
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12 months
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Change From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6
Időkeret: 6 months
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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 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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6 months
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Change From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 12
Időkeret: 12 months
|
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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12 months
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Change From Baseline in Participant Fatigue Score at Month 6
Időkeret: 6 months
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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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6 months
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Change From Baseline in Participant Fatigue Score at Month 12
Időkeret: 12 months
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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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12 months
|
Change From Baseline in Participant Pain Score at Month 6
Időkeret: 6 months
|
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.
|
6 months
|
Change From Baseline in Participant Pain Score at Month 12
Időkeret: 12 months
|
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.
|
12 months
|
Number of participants achieving low disease activity at 6 months
Időkeret: 6 months
|
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.
Here, all participants who achieved remission (DAS28-ESR <=3.2) at Month 6 have been reported
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6 months
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Number of participants achieving low disease activity at 12 months
Időkeret: 12 months
|
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.
Here, all participants who achieved remission (DAS28-ESR <=3.2) at Month 6 have been reported
|
12 months
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6
Időkeret: 6 months
|
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.
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6 months
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 12
Időkeret: 12 months
|
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.
|
12 months
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6
Időkeret: 6 month
|
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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6 month
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Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 12
Időkeret: 12 month
|
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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12 month
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Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline up to 6 months
Időkeret: 6 months
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MCID improvement assessed based on HAQ.
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.
MCID improvement defined by difference in HAQ from baseline (at time of tofacitinib initiation) to 6 month visit of at least 0.22
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6 months
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Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline up to 12 months
Időkeret: 12 months
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MCID improvement assessed based on HAQ.
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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12 months
|
Change from baseline in Participant morning stiffness
Időkeret: 6 months
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Participants were asked the following question to answer: "If you have morning stiffness, how long does it take until you feel as limber as you will for the day?" in hours and minutes.
Higher scores indicated a worsening of conditions.
Total hours were reported for all participants at 6 months who reported morning stiffness >0 at baseline
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6 months
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Change from baseline in Participant morning stiffness
Időkeret: 12 months
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Participants were asked the following question to answer: "If you have morning stiffness, how long does it take until you feel as limber as you will for the day?" in hours and minutes.
Higher scores indicated a worsening of conditions.
Total hours were reported for all participants at 12 months who reported morning stiffness >0 at baseline
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12 months
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2021. január 22.
Elsődleges befejezés (Tényleges)
2021. november 29.
A tanulmány befejezése (Tényleges)
2021. november 29.
Tanulmányi regisztráció dátumai
Először benyújtva
2021. január 19.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2021. január 19.
Első közzététel (Tényleges)
2021. január 25.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2022. június 9.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2022. június 8.
Utolsó ellenőrzés
2022. június 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Patológiás folyamatok
- Immunrendszeri betegségek
- Autoimmun betegség
- Ízületi betegségek
- Mozgásszervi betegségek
- Reumás betegségek
- Kötőszöveti betegségek
- Ízületi gyulladás
- Ízületi gyulladás, rheumatoid
- Elhalás
- A farmakológiai hatás molekuláris mechanizmusai
- Enzim gátlók
- Protein kináz inhibitorok
- Tofacitinib
Egyéb vizsgálati azonosító számok
- A3921389
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
IPD terv leírása
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.
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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PfizerBefejezve
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