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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
22mg qd,Once a day for 7 consecutive days
Peking Union Medical College hospital
Beijing, Dongcheng, China
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
Time frame: 24 weeks
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
Time frame: 24 weeks
Change in PASI From Baseline From Baseline
Psoriasis Area and Severity Index
Time frame: 24 weeks
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.
Time frame: 24 weeks
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 weeks
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.
Time frame: 24 weeks
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
Time frame: 24 weeks
Change in Tender Joint Count (TJC) 68 from baseline
TJC is determined by physical examination of 68 joint counts that are assessed for tenderness.
Time frame: 12 weeks and 24 weeks
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.
Time frame: 12 weeks and 24 weeks