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Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy

3. února 2015 aktualizováno: Pfizer

Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy

People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Observational prospective study Purely descriptive

Typ studie

Pozorovací

Zápis (Aktuální)

62

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Belgie
      • Leuven, Belgie, 3000
        • UZ Gasthuisberg

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

patients seen in a rheumatology practice

Popis

Inclusion Criteria:

Patients who:

  • Are active RA patients (as judged by treating MD)
  • Are 18 years of age or older at time of consent
  • Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX

Exclusion Criteria:

Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.

Participation in other clinical or observational trials

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
RA Patients treated with SC anti-TNF
Jiný: SC anti-TNF
SC anti-TNF

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
Časové okno: Baseline
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Baseline
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
Časové okno: Month 6
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Month 6
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
Časové okno: Month 12
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Month 12
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
Časové okno: Month 18
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Month 18
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
Časové okno: Month 24
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Month 24

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Visual Analog Scale (VAS) Fatigue Score
Časové okno: Baseline, Month 6, 12, 18, 24
Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
Baseline, Month 6, 12, 18, 24
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
Časové okno: Baseline, Month 6, 12, 18, 24
DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score=more disease activity (DA). DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA
Baseline, Month 6, 12, 18, 24
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Časové okno: Baseline, Month 6, 12, 18, 24
DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.
Baseline, Month 6, 12, 18, 24
Health Assessment Questionnaire (HAQ) Total Score
Časové okno: Baseline, Month 6, 12, 18, 24
HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of item scores. HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.
Baseline, Month 6, 12, 18, 24

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
Časové okno: Baseline, Month 6, 12, 18, 24
Spearman correlation coefficient between AIMS2 component score and VAS fatigue score (AIMS2 component score versus [vs] VAS fatigue) was calculated. AIMS2 : 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and VAS score: Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
Baseline, Month 6, 12, 18, 24
Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)
Časové okno: Baseline, Month 6,1 2, 18, 24
Pearson correlation coefficient between AIMS2 component score and DAS28-ESR score (AIMS2 component score vs DAS28-ESR) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA.
Baseline, Month 6,1 2, 18, 24
Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Časové okno: Baseline, Month 6, 12, 18, 24
Pearson correlation coefficient between AIMS2 component score and DAS28-CRP score (AIMS2 component score vs DAS28-CRP) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission.
Baseline, Month 6, 12, 18, 24
Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score
Časové okno: Baseline, Month 6, 12, 18, 24
Spearman correlation coefficient between DAS28-ESR and VAS fatigue (DAS28-ESR vs VAS score) was calculated. DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA and VAS fatigue = Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
Baseline, Month 6, 12, 18, 24
Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score
Časové okno: Baseline, Month 6, 12, 18, 24
Spearman correlation coefficient between DAS28-CRP and VAS score (DAS28-CRP vs VAS score) was calculated. DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission and VAS= Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
Baseline, Month 6, 12, 18, 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2010

Primární dokončení (Aktuální)

1. února 2014

Dokončení studie (Aktuální)

1. února 2014

Termíny zápisu do studia

První předloženo

19. srpna 2011

První předloženo, které splnilo kritéria kontroly kvality

30. ledna 2012

První zveřejněno (Odhad)

31. ledna 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

19. února 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. února 2015

Naposledy ověřeno

1. února 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 0881A1-4748
  • B1801046 (Jiný identifikátor: Alias Study Number)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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