Systemic Sclerosis Clinical and Biomarker Study
30. oktober 2015 opdateret af: Biogen
A Multicenter, Prospective, Longitudinal Study to Evaluate Gastrointestinal Function and Clinical and Molecular Biomarkers in Subjects With Early and Late Diffuse Cutaneous Systemic Sclerosis, Limited Cutaneous Systemic Sclerosis, and Healthy Volunteers
The primary objective of the study is to assess the change in systemic sclerosis (SSc)-associated gastrointestinal (GI) tract symptoms over a 1-year period in participants with SSc.
Studieoversigt
Status
Trukket tilbage
Betingelser
Detaljeret beskrivelse
No study treatment will be administered.
Study participants will continue to be treated by their respective physicians according to standard clinical practice.
Data on concomitant therapy and procedures, administered as part of standard of care, will be collected at baseline and at each study visit.
Undersøgelsestype
Observationel
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
Study participants will be recruited at participating locations in a standard clinical practice setting.
Beskrivelse
Key Inclusion Criteria:
Healthy volunteers
- Must be in good health as determined by the Investigator, based on medical history, physical examination, and vital signs.
Participants with diffuse cutaneous systemic sclerosis (dcSSc):
- Must fulfill the 2013 classification criteria for SSc of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
- Absence of the anti-centromere autoantibody.
Participants with limited cutaneous systemic sclerosis (lcSSc):
- Must fulfill the 2013 classification criteria for SSc of the ACR and EULAR.
- Subjects with lcSSc must have disease duration of less than 5 years.
Key Exclusion Criteria:
- History of any clinically significant medical condition that can interfere with the conduct of the study, or that in the opinion of the Investigator, would compromise data interpretation.
- An active severe infection as determined by the Investigator.
- Female subjects who are pregnant or currently breastfeeding.
- A known history of malignancy.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Healthy
Approximately 10 healthy adults will be enrolled into this study
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SSc
Participants with dcSSc and lcSSc
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in University of California at Los Angeles Scleroderma Clinical Trial Consortium GI Tract (UCLA-SCTC GIT) instrument score in participants with SSc
Tidsramme: Baseline to Month 12
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This participant-reported assessment is a 34-item instrument designed to measure GI tract involvement in participants with SSc.
The UCLA SCTC GIT 2.0 has 7 multi-item scales: Reflux, Distension/Bloating, Diarrhea, Fecal Soilage, Constipation, Emotional Well-being, and Social Functioning and a total GIT score.
All scales are scored from 0 [better health-related quality of life (HRQOL)] to 3 (worse HRQOL) except the diarrhea and constipation scales (ranges 0-2 and 0-2.5, respectively).
The Total GIT Score, is developed by averaging 6 of 7 scales (excluding constipation) with lower scores indicating better HRQOL.
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Baseline to Month 12
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. december 2015
Primær færdiggørelse (Forventet)
1. marts 2017
Studieafslutning (Forventet)
1. marts 2017
Datoer for studieregistrering
Først indsendt
20. august 2015
Først indsendt, der opfyldte QC-kriterier
20. august 2015
Først opslået (Skøn)
21. august 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. oktober 2015
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 995SS001
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 .