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

NCT05000086 | Completed Phase 4

• 1 other identifier: YK1901PsA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Psoriatic

Keywords

99Tc-MDP

Outcome Measures

Primary Outcomes (2)

• 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

  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

  24 weeks

Secondary Outcomes (7)

• Change in PASI From Baseline From Baseline

  24 weeks

• Change in HAQ-DI Score From Baseline

  24 weeks

• ACR20

  12 weeks

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

  24 weeks

• Percentage of Participants in MDA

  24 weeks

Study Arms (1)

99Tc methylene diphosphonate

EXPERIMENTAL

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.

Drug: 99Tc methylene diphosphonate

Interventions

99Tc methylene diphosphonate DRUG

22mg qd，Once a day for 7 consecutive days

Also known as: Yunke

99Tc methylene diphosphonate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Chengdu Yunke Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College hospital

Beijing, Dongcheng, 100730, China

Location

Related Publications (4)

• 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.

  PMID: 30421571 BACKGROUND

• 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.

  PMID: 29356462 BACKGROUND

• 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.

  PMID: 34039871 BACKGROUND

• 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.

  PMID: 24467668 BACKGROUND

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: June 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 5 years after article publication
• 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

Locations

CN (1)