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Arthritis, PsoriaticPhase 4NCT05000086

A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis

A Phase 4 study testing 99Tc methylene diphosphonate in people with Arthritis, Psoriatic, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
99Tc methylene diphosphonate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Jun 2019to 1 Jul 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College hospital

    Beijing, Dongcheng, 100730

Other trials in China

About this study

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.

Read the detailed description

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.

Being tested
99Tc methylene diphosphonate
Keywords
99Tc-MDP
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 99Tc methylene diphosphonateDrug

    Also called Yunke

    22mg qd，Once a day for 7 consecutive days

Study groups in NCT05000086
Study groupRoleWhat they receive
99Tc methylene diphosphonateExperimental99Tc-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.
Receives: Drug: 99Tc methylene diphosphonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Achieving DAS28-CRP<=3.2

    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

    Measured: 24 weeks

  2. Proportion of Patients Achieving DAS28-ESR<=3.2

    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

    Measured: 24 weeks

Secondary outcomes (7)

  1. Change in PASI From Baseline From Baseline

    Psoriasis Area and Severity Index

    Measured: 24 weeks

  2. Change in HAQ-DI Score From Baseline

    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.

    Measured: 24 weeks

  3. ACR20

    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.

    Measured: 12 weeks

  4. Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline

    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.

    Measured: 24 weeks

  5. Percentage of Participants in MDA

    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

    Measured: 24 weeks

  6. Change in Tender Joint Count (TJC) 68 from baseline

    TJC is determined by physical examination of 68 joint counts that are assessed for tenderness.

    Measured: 12 weeks and 24 weeks

  7. Change in Swollen Joint Count (SJC) 66 from baseline

    SJC is determined by physical examination of 66 joint counts that are classified as either swollen or not swollen.

    Measured: 12 weeks and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start1 Jun 2019
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05000086
Sponsor's protocol ID
YK1901PsA
Status last verified
Jul 2021
First submitted
3 Aug 2021
Last updated
11 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

  • 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.

    PubMed 30421571

  • 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.

    PubMed 29356462

  • 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.

    PubMed 34039871

  • 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.

    PubMed 24467668

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 99Tc methylene diphosphonate in people with Arthritis, Psoriatic, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Achieving DAS28-CRP<=3.2 (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05000086, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.

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