- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01521884
Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
3. februar 2015 opdateret af: 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.
Studieoversigt
Detaljeret beskrivelse
Observational prospective study Purely descriptive
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
62
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Leuven, Belgien, 3000
- UZ Gasthuisberg
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
patients seen in a rheumatology practice
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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RA Patients treated with SC anti-TNF
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SC anti-TNF
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
Tidsramme: 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
Tidsramme: Month 6
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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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Month 6
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
Tidsramme: Month 12
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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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Month 12
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
Tidsramme: Month 18
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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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Month 18
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
Tidsramme: Month 24
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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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Month 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Visual Analog Scale (VAS) Fatigue Score
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2010
Primær færdiggørelse (Faktiske)
1. februar 2014
Studieafslutning (Faktiske)
1. februar 2014
Datoer for studieregistrering
Først indsendt
19. august 2011
Først indsendt, der opfyldte QC-kriterier
30. januar 2012
Først opslået (Skøn)
31. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. februar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. februar 2015
Sidst verificeret
1. februar 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0881A1-4748
- B1801046 (Anden identifikator: Alias Study Number)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Rheumatoid arthritis
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Janssen Research & Development, LLCTrukket tilbageAktiv reumatoid arthritis; Rheumatoid arthritis
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Healthcare Homoeo Charitable SocietyUkendtRheumatoid arthritis.Indien
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Federal University of São PauloAfsluttetRheumatoid arthritis.Brasilien
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Hamad Medical CorporationUkendtRHEUMATOID ARTHRITISQatar
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Richard Burt, MDAfsluttet
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Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUkendt- Rheumatoid arthritisBrasilien
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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University of SalfordAfsluttetRheumatoid arthritis | Håndslidgigt | Inflammatorisk arthritisDet Forenede Kongerige
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Link America, Inc.AfsluttetSlidgigt | Rheumatoid arthritis | Post-traumatisk arthritisForenede Stater
Kliniske forsøg med SC anti-TNF
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PfizerAfsluttet
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HaEmek Medical Center, IsraelUniversity of Toronto; Mount Sinai Hospital, CanadaAfsluttetColitis ulcerosa | Anti TNF terapi | Ileal Pouch Anal Anastomosis (IPAA)
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TakedaAfsluttetInflammatoriske tarmsygdomme | Crohns sygdom | Colitis, UlcerativKina, Korea, Republikken, Taiwan, Den Russiske Føderation, Kalkun, Argentina, Colombia, Mexico, Saudi Arabien, Singapore
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Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases...AfsluttetJuvenil idiopatisk arthritisForenede Stater
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Universidade Federal do Rio de JaneiroUkendtGigt | PsoriasisgigtBrasilien
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NeovacsAfsluttetCrohns sygdomTyskland, Belgien, Frankrig, Rumænien, Bulgarien, Kroatien, Tjekkiet, Ungarn, Holland
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Assistance Publique - Hôpitaux de ParisUkendtRheumatoid arthritis | Psoriasis | Crohns sygdom | Ankyloserende spondylitisFrankrig
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Janssen Biotech, Inc.Afsluttet
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Immunicom IncRekruttering