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- Klinische proef NCT01521884
Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
3 februari 2015 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
Observational prospective study Purely descriptive
Studietype
Observationeel
Inschrijving (Werkelijk)
62
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Leuven, België, 3000
- UZ Gasthuisberg
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
patients seen in a rheumatology practice
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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RA Patients treated with SC anti-TNF
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SC anti-TNF
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
Tijdsspanne: Baseline
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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.
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Baseline
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
Tijdsspanne: 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.
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Month 6
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
Tijdsspanne: 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.
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Month 12
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
Tijdsspanne: 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.
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Month 18
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
Tijdsspanne: 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.
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Month 24
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Visual Analog Scale (VAS) Fatigue Score
Tijdsspanne: Baseline, Month 6, 12, 18, 24
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Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
Tijdsspanne: Baseline, Month 6, 12, 18, 24
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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
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Baseline, Month 6, 12, 18, 24
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Tijdsspanne: Baseline, Month 6, 12, 18, 24
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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.
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Baseline, Month 6, 12, 18, 24
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Health Assessment Questionnaire (HAQ) Total Score
Tijdsspanne: Baseline, Month 6, 12, 18, 24
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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.
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Baseline, Month 6, 12, 18, 24
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
Tijdsspanne: Baseline, Month 6, 12, 18, 24
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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.
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Baseline, Month 6, 12, 18, 24
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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)
Tijdsspanne: Baseline, Month 6,1 2, 18, 24
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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.
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Baseline, Month 6,1 2, 18, 24
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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)
Tijdsspanne: Baseline, Month 6, 12, 18, 24
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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.
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Baseline, Month 6, 12, 18, 24
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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
Tijdsspanne: Baseline, Month 6, 12, 18, 24
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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.
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Baseline, Month 6, 12, 18, 24
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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
Tijdsspanne: 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.
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Baseline, Month 6, 12, 18, 24
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2010
Primaire voltooiing (Werkelijk)
1 februari 2014
Studie voltooiing (Werkelijk)
1 februari 2014
Studieregistratiedata
Eerst ingediend
19 augustus 2011
Eerst ingediend dat voldeed aan de QC-criteria
30 januari 2012
Eerst geplaatst (Schatting)
31 januari 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
19 februari 2015
Laatste update ingediend die voldeed aan QC-criteria
3 februari 2015
Laatst geverifieerd
1 februari 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0881A1-4748
- B1801046 (Andere identificatie: Alias Study Number)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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