Skip to main content
OpenTrials
Completed

NCT Number: NCT05000086

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking Union Medical College hospital

Beijing, Dongcheng, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

99Tc methylene diphosphonate

Drug

22mg qd，Once a day for 7 consecutive days

Other names: Yunke

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

Secondary outcomes

  1. Change in PASI From Baseline From Baseline

    Time frame: 24 weeks

    Psoriasis Area and Severity Index

  2. Change in HAQ-DI Score From Baseline

    Time frame: 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.

  3. ACR20

    Time frame: 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.

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

    Time frame: 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.

  5. Percentage of Participants in MDA

    Time frame: 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

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

    Time frame: 12 weeks and 24 weeks

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

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

    Time frame: 12 weeks and 24 weeks

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Chengdu Yunke Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2021
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.