A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
3. august 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Dongcheng
-
Beijing, Dongcheng, Kina, 100730
- Peking Union Medical College Hospital
-
-
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 til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
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.
Generelle publikationer
- 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.
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 (Faktiske)
1. juni 2019
Primær færdiggørelse (Faktiske)
1. juli 2021
Studieafslutning (Faktiske)
1. juli 2021
Datoer for studieregistrering
Først indsendt
3. august 2021
Først indsendt, der opfyldte QC-kriterier
3. august 2021
Først opslået (Faktiske)
11. august 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. august 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- YK1901PsA
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
IPD-delingsadgangskriterier
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 Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .