Back to resultsA Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
Primary Purpose
Arthritis, Psoriatic
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
99Tc methylene diphosphonate
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Psoriatic focused on measuring 99Tc-MDP
Eligibility Criteria
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
Sites / Locations
- Peking Union Medical College hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
99Tc methylene diphosphonate
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change in PASI From Baseline From Baseline
Psoriasis Area and Severity Index
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.
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.
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.
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
Change in Tender Joint Count (TJC) 68 from baseline
TJC is determined by physical examination of 68 joint counts that are assessed for tenderness.
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.
Full Information
NCT ID
NCT05000086
First Posted
August 3, 2021
Last Updated
August 3, 2021
Sponsor
Peking Union Medical College Hospital
Collaborators
Chengdu Yunke Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05000086
Brief Title
A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
Official Title
A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Chengdu Yunke Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic
Keywords
99Tc-MDP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
99Tc methylene diphosphonate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
99Tc methylene diphosphonate
Other Intervention Name(s)
Yunke
Intervention Description
22mg qd，Once a day for 7 consecutive days
Primary Outcome Measure Information:
Title
Proportion of Patients Achieving DAS28-CRP<=3.2
Description
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
Title
Proportion of Patients Achieving DAS28-ESR<=3.2
Description
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
Secondary Outcome Measure Information:
Title
Change in PASI From Baseline From Baseline
Description
Psoriasis Area and Severity Index
Time Frame
24 weeks
Title
Change in HAQ-DI Score From Baseline
Description
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
Title
ACR20
Description
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.
Time Frame
12 weeks
Title
Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline
Description
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
Title
Percentage of Participants in MDA
Description
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
Title
Change in Tender Joint Count (TJC) 68 from baseline
Description
TJC is determined by physical examination of 68 joint counts that are assessed for tenderness.
Time Frame
12 weeks and 24 weeks
Title
Change in Swollen Joint Count (SJC) 66 from baseline
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peking Union Medical College hospital
City
Beijing
State/Province
Dongcheng
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years after article publication
IPD Sharing Access Criteria
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
Citations:
PubMed Identifier
30421571
Citation
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.
Results Reference
background
PubMed Identifier
29356462
Citation
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.
Results Reference
background
PubMed Identifier
34039871
Citation
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.
Results Reference
background
PubMed Identifier
24467668
Citation
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.
Results Reference
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A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
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