Study of Arthritis and Related Conditions
11 mars 2021 uppdaterad av: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Studies of the Pathogenesis and Natural History of Arthritis and Related Conditions
This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions.
Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients.
Additional imaging using sensitive MRI methods will be obtained in some patients.
The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases.
Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status.
Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions.
Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients.
Additional imaging using sensitive MRI methods will be obtained in some patients.
The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases.
Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status.
Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.
Studietyp
Observationell
Inskrivning (Faktisk)
697
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Maryland
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Bethesda, Maryland, Förenta staterna, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Subjects with known or suspected arthritis
Beskrivning
- INCLUSION CRITERIA:
No age limits.
History of inflammatory synovitis of at least one or more swollen joints.
Patient's ability and willingness to give informed consent or in the pediatric patients, the parent's willingness to give informed consent and the patient's willingness to assent to the protocol whenever possible.
EXCLUSION CRITERIA:
None if patients fulfill inclusion criteria.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Subjects with known or suspected arthritis
Subjects with known or suspected arthritis will be evaluated longitudinally
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Determine patterns of arthritis
Tidsram: End of the study
|
Evaluate natural history and disease trajectories in rheumatoid arthritis
|
End of the study
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Confirmatory Studies In RA and related diseases
Tidsram: End of the study
|
We would like to continue confirmatory studies and test whether serologic disease markers identified early in the course of the disease are indeed markers of disease severity in patients with more established forms of the disease.
|
End of the study
|
|
Co-culture experiments using synovial tissue and surgical cartilage specimens
Tidsram: End of the study
|
The erosive potential of some but not all forms of arthritis is still poorly understood.
We propose to resume co-culture experiments using synovial tissue and surgical cartilage specimens to develop a tissue model of bone erosions using the bioreactor
|
End of the study
|
|
MRI Imaging in RA and related diseases
Tidsram: End of the study
|
We would like to use patients from this cohort to develop the analysis of MRI images, including three dimensionally reconstructed images, and test their use in the evaluation of joint damage and impact on early diagnosis and therapeutic decisions.
|
End of the study
|
|
Collection of DNA in RA and related diseases
Tidsram: End of the study
|
Genetic associations need to be tested in large populations of patients with heterogenous diseases.
We would like to continue the collection of DNA in a cohort of clinically well-characterized patients to allow for genetic analysis once a critical body of patients has been collected.
|
End of the study
|
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Evaluation of early disability in RA and related diseases
Tidsram: End of the study
|
Analysis of the degree of early disability resulting from inflammatory arthritis in the early synovitis cohort patients is currently ongoing.
We intend to continue work with the rehabilitation department on the analysis of the extent of disability related to the inflammatory conditions and associated factors in the adult and pediatric population.
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End of the study
|
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Assess cytokine profiles
Tidsram: End of the study
|
We would like to comprehensively assess cytokine profiles in the serum of patients with pauciarticular, poly-articular and systemic onset JRA and the influence of response to treatment on cytokine changes.
|
End of the study
|
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Correlate the cartilage and bone markers of tissue destruction and repair with MRI images
Tidsram: End of the study
|
We would further like to correlate the cartilage and bone markers of tissue destruction and repair with the amount of damage seen on MRI in the different patient disease subsets.
|
End of the study
|
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Determine the degree of early disability
Tidsram: End of the study
|
Very subtle degrees of early disability have been seen in patients with relatively short disease duration.
We would like to determine the degree of early disability in JRA patients and correlate measures of disability with the number, joint location and degree of joint damage on MRI.
|
End of the study
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: James D Katz, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 oktober 2000
Primärt slutförande (Faktisk)
10 mars 2021
Avslutad studie (Faktisk)
10 mars 2021
Studieregistreringsdatum
Först inskickad
4 oktober 2000
Först inskickad som uppfyllde QC-kriterierna
4 oktober 2000
Första postat (Uppskatta)
5 oktober 2000
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 mars 2021
Senast verifierad
1 mars 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 000222
- 00-AR-0222
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