- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05000086
A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
3. august 2021 oppdatert av: Peking Union Medical College Hospital
This study is aim to evaluate the efficacy and safety of technetium [99Tc] methylene diphosphonate (99Tc-MDP, trade name: Yunke) in the treatment of psoriatic arthritis.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a single-arm, open label, 24 weeks study.
Patients with psoriatic arthritis get 99Tc-MDP 22mg (5.5mg/set, four sets) was injected intravenously once a day for 7 successive days, one course every 4 weeks until week 24.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Dongcheng
-
Beijing, Dongcheng, Kina, 100730
- Peking Union Medical College Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 18-70 years of age;
- Clinical diagnosis of PsA according to the CASPAR classification criteria
- Active PsA at baseline defined as ≥ 3 tender joints and ≥ 3 swollen joints
- If subjects were taking csDMARDs, the doses of csDMARDs had to be stable for at least 4 weeks and had to remain the same during the trial
The application of bDMARDs and tsDMARDs should meet the following requirements:
- Etanercept and its biological analogues: stop at least 4 weeks prior to their baseline visit;
- Other biological: stop at least 6 months prior to their baseline visit
- tsDMARDs: stop at least 8 weeks prior to their baseline visit
- If subjects were taking glucocorticoids, the doses of GC(prednisone < 10mg) had to be stable for at least 4 weeks and had to remain the same during the trial;
- Non steroidal anti-inflammatory drugs: if applied, the dose was stable one week prior to their baseline visit
- Negative pregnancy test for child-bearing women at screening and baseline
- Provide written informed consent
Exclusion Criteria:
- Patients with severe heart, liver, kidney and other important organ diseases
- Abnormal liver function (ALT or AST is 2 times higher than normal)
- White blood cell count less than 4,000/mm^3 (less than 4 X 10^9/L)
- Platelet count less than 100,000/mm^3 (less than 100 X 10^9/L)
- Serum creatinine more than or equal to 1.5 mg/dL (less than or equal to 132.6 μmol/L)
- Pregnancy or breastfeeding women
- Contraindications to 99Tc-MDP therapy and/or known hypersensitivity to 99Tc-MDP
- Participated in other drugs clinical trials within 4 weeks
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 99Tc methylene diphosphonate
99Tc-MDP was applied as follows: for each course of treatment, 99Tc-MDP 22 mg (5.5mg/set, four sets) was injected intravenously once a day for 7 successive days, one course every 4 weeks until week 24.
|
22mg qd,Once a day for 7 consecutive days
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Proportion of Patients Achieving DAS28-CRP<=3.2
Tidsramme: 24 weeks
|
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment.
Scores can take any positive value with a lower value indicating a better clinical condition.
DAS28-CRP score of <=3.2 indicates low disease activity.
<2.6 means disease remission
|
24 weeks
|
Proportion of Patients Achieving DAS28-ESR<=3.2
Tidsramme: 24 weeks
|
DAS28-ESR: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (ESR) and the patient's own assessment.
Scores can take any positive value with a lower value indicating a better clinical condition.
DAS28-ESR score of <=3.2 indicates low disease activity.
<2.6 means disease remission
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in PASI From Baseline From Baseline
Tidsramme: 24 weeks
|
Psoriasis Area and Severity Index
|
24 weeks
|
Change in HAQ-DI Score From Baseline
Tidsramme: 24 weeks
|
The HAQ-DI is a standardized measure of physical function in arthritis.
The HAQ-DI questionnaire contains 20 items divided into 8 domains that measure: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
|
24 weeks
|
ACR20
Tidsramme: 12 weeks
|
The ACR is a standard criteria originally developed to measure the effectiveness of various arthritis medications or treatments in clinical trials for RA, but is also widely used in PsA.
The ACR measures improvement in tender joint count (TJC) or swollen joint count (SJC), and improvement in at least 3 of the following 5 parameters: Patient Global Assessment (PtGA), Physician's Global Assessment of Disease Activity (PhGA), physical function (using HAQ-DI) and acute phase reactant (using CRP).
ACR 20 response is achieved if ≥ 20% improvement in tender joint count (TJC) or swollen joint count (SJC) as well as a ≥ 20%/≥ 50%/≥ 70% improvement in ≥ 3 of the other 5 parameters.
|
12 weeks
|
Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline
Tidsramme: 24 weeks
|
Disease Activity in Psoriatic Arthritis Score (DAPSA) score is a the sum of swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/dL), Patient's Assessment of Pain (on a 10-unit VAS;0=no pain, 10=worst possible pain), and Patient's Global Assessment of Disease Activity (arthritis, on a 10-unit VAS; 0 to 100 centimeter [cm] VAS, 0=excellent and 10=poor).
Change from baseline in DAPSA measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates worsening of disease activity.
|
24 weeks
|
Percentage of Participants in MDA
Tidsramme: 24 weeks
|
MDA for PsA was defined as fulfilling at least 5 of the following 7 criteria: TJC ≤ 1 (out of TJC68 assessed in this study), SJC ≤ 1 (out of SJC66 assessed in this study), PASI ≤ 1 or BSA ≤ 3; Patient's assessment of pain VAS ≤ 15, PtGA VAS ≤ 20, HAQ-DI score ≤ 0.5, and tender entheseal points ≤ 1
|
24 weeks
|
Change in Tender Joint Count (TJC) 68 from baseline
Tidsramme: 12 weeks and 24 weeks
|
TJC is determined by physical examination of 68 joint counts that are assessed for tenderness.
|
12 weeks and 24 weeks
|
Change in Swollen Joint Count (SJC) 66 from baseline
Tidsramme: 12 weeks and 24 weeks
|
SJC is determined by physical examination of 66 joint counts that are classified as either swollen or not swollen.
|
12 weeks and 24 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Shen S, Wang W, Yang C, Xu B, Zeng L, Qian Y. Effect of technetium-99 conjugated with methylene diphosphonate (99 Tc-MDP) on OPG/RANKL/RANK system in vitro. J Oral Pathol Med. 2019 Feb;48(2):129-135. doi: 10.1111/jop.12801. Epub 2018 Dec 9.
- Mu R, Liang J, Sun L, Zhang Z, Liu X, Huang C, Zhu P, Zuo X, Gu J, Li X, Li X, Liu Y, Feng P, Li Z. A randomized multicenter clinical trial of 99 Tc-methylene diphosphonate in treatment of rheumatoid arthritis. Int J Rheum Dis. 2018 Jan;21(1):161-169. doi: 10.1111/1756-185X.12934. Epub 2017 Feb 3.
- Fu Q, Feng P, Sun LY, Zuo XX, Zhao DB, He DY, Wu HX, Zhang W, Zhang W, Du F, Bao CD. A double-blind, double-dummy, randomized controlled, multicenter trial of 99Tc-methylene diphosphonate in patients with moderate to severe rheumatoid arthritis. Chin Med J (Engl). 2021 May 19;134(12):1457-1464. doi: 10.1097/CM9.0000000000001527.
- Su D, Shen M, Gu B, Wang X, Wang D, Li X, Sun L. (99) Tc-methylene diphosphonate improves rheumatoid arthritis disease activity by increasing the frequency of peripheral gammadelta T cells and CD4(+) CD25(+) Foxp3(+) Tregs. Int J Rheum Dis. 2016 Jun;19(6):586-93. doi: 10.1111/1756-185X.12292. Epub 2014 Jan 28.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2019
Primær fullføring (Faktiske)
1. juli 2021
Studiet fullført (Faktiske)
1. juli 2021
Datoer for studieregistrering
Først innsendt
3. august 2021
Først innsendt som oppfylte QC-kriteriene
3. august 2021
Først lagt ut (Faktiske)
11. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2021
Sist bekreftet
1. juli 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Leddsykdommer
- Muskel- og skjelettsykdommer
- Hudsykdommer, Papulosquamous
- Spinal sykdommer
- Beinsykdommer
- Spondylarthropatier
- Spondylartritt
- Spondylitt
- Psoriasis
- Leddgikt
- Leddgikt, psoriasis
- Fysiologiske effekter av legemidler
- Bone Density Conservation Agents
- Metylendifosfonat
- Difosfonater
Andre studie-ID-numre
- YK1901PsA
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All of the individual participant data collected during the trial, after deidentification.
IPD-delingstidsramme
Beginning 3 months and ending 5 years after article publication
Tilgangskriterier for IPD-deling
Researchers who provide a methodologically sound proposal.
Proposals should be directed to lpumch@126.com.
To gain access, data requestors will need to sign a data access agreement
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på 99Tc methylene diphosphonate
-
Xinhua Hospital, Shanghai Jiao Tong University...FullførtOsteoporose | Differensiert kreft i skjoldbruskkjertelenKina
-
Cell>Point LLCFullført
-
University of ManitobaWinnipeg Regional Health AuthorityAvsluttet
-
Cell>Point LLCVenn Life Sciences; Numoda; Camargo Pharmaceutical Services; Biomedical ServicesFullførtIkke småcellet lungekreftForente stater, Canada
-
London School of Hygiene and Tropical MedicineFullførtMalaria | AnemiTanzania
-
Cell>Point LLCVenn Life Sciences; Biomedical Systems; Numoda; Camargo Pharmaceutical ServicesFullførtIkke småcellet lungekreftForente stater
-
Stanford UniversityNational Cancer Institute (NCI)FullførtTilbakevendende melanomForente stater
-
National Cancer Institute (NCI)FullførtProstata karsinom | Ingen tegn på sykdomForente stater
-
Xinhua Hospital, Shanghai Jiao Tong University...Rekruttering
-
Reata, a wholly owned subsidiary of BiogenFullførtFriske FrivilligeForente stater